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XTX202 bei Patienten mit fortgeschrittenen soliden Tumoren

30. April 2026 aktualisiert von: Xilio Development, Inc.

Eine First-in-Human, Multicenter, Phase 1/2, Open-Label-Studie von XTX202 bei Patienten mit fortgeschrittenen soliden Tumoren

Eine First-in-Human, Multicenter, Phase 1/2, Open-Label-Studie von XTX202 bei Patienten mit fortgeschrittenen soliden Tumoren

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Dies ist eine erste multizentrische Phase-1/2-Open-Label-Studie am Menschen zur Bewertung der Sicherheit, Verträglichkeit und Wirksamkeit von XTX202, einem technisch hergestellten IL-2-Prodrug mit maskierter Aktivität, als Monotherapie bei Patienten mit fortgeschrittenem Status solide Tumore.

Phase 1, Teil 1a, wird die XTX202-Monotherapie in einem beschleunigten und standardmäßigen 3+3-Dosiseskalationsdesign untersuchen. Basierend auf den Ergebnissen von Teil 1a wird Teil 1b eingeleitet, um XTX202 bei Patienten mit ausgewählten fortgeschrittenen soliden Tumoren weiter zu untersuchen und XTX202 weiter zu charakterisieren.

Basierend auf den Ergebnissen von Phase 1 werden Patienten mit ausgewählten fortgeschrittenen soliden Tumoren in Phase 2 aufgenommen.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

95

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • La Jolla, California, Vereinigte Staaten, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Vereinigte Staaten, 90095
        • University of California Los Angeles
      • Los Angeles, California, Vereinigte Staaten, 90033
        • Norris Comprehensive Cancer Center
      • Newport Beach, California, Vereinigte Staaten, 92663
        • Hoag Memorial Hospital Presbyterian- Newport Beach
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20007
        • Georgetown University Medical Center
    • Florida
      • Tampa, Florida, Vereinigte Staaten, 33612
        • Moffitt Cancer Center
    • Iowa
      • Iowa City, Iowa, Vereinigte Staaten, 52242
        • University of Iowa Hospitals and Clinics
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Saint Paul, Minnesota, Vereinigte Staaten, 55101
        • HealthPartners Cancer Center at regions Hospital
    • New Jersey
      • Morristown, New Jersey, Vereinigte Staaten, 07960
        • Atlantic Health System/Morristown Medical Center
      • New Brunswick, New Jersey, Vereinigte Staaten, 08903
        • Rutgers Cancer Institute of NJ
    • North Carolina
      • Huntersville, North Carolina, Vereinigte Staaten, 28078
        • Carolina BioOncology Institute
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • UPMC Hillman Cancer Center Pavilion
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37203
        • Sarah Cannon Research Institute

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  1. Krankheitskriterien

    • Phase 1, Teil 1a: Jede histologisch oder zytologisch bestätigte Malignität eines soliden Tumors, die lokal fortgeschritten oder metastasiert ist und bei der die Standardtherapie versagt hat oder die Standardtherapie nicht kurativ oder verfügbar ist
    • Phase 1, Teil 1b: Histologisch oder zytologisch bestätigter maligner solider Tumor mit einer der folgenden Tumorhistologien: RCC nur mit klarzelliger Histologie, Melanom, Plattenepithelkarzinom der Haut, Eierstockkrebs, nicht-kleinzelliger Lungenkrebs. Die Patienten müssen mit einer verfügbaren Standardtherapie behandelt worden sein. Patienten, die zuvor eine Immuntherapie erhalten haben, müssen von dieser Behandlung profitiert haben. Darüber hinaus können Patienten mit einer der oben genannten Histologien in einem fortgeschrittenen Setting, die sich einer Debulking-Operation oder einer Oligometastasektomie unterziehen möchten, für eine Behandlung mit 2 Zyklen XTX202 in einer Subkohorte des „Fensters der Gelegenheit“ in Frage kommen.
    • Phase 2, Teil 2a: Patienten mit metastasiertem RCC, die zuvor mit einem zugelassenen Anti-PD-1 und einem TKI behandelt wurden. Die Patienten müssen unter der Behandlung mit einem Anti-PD-1-mAb, der entweder als Monotherapie oder in Kombination mit anderen Therapien verabreicht wurde, Fortschritte gemacht haben
    • Phase 2, Teil 2b: Patienten mit inoperablem oder metastasiertem Melanom, die zuvor mit einem zugelassenen Anti-PD-1- und einem Anti-CTLA4-Checkpoint-Inhibitor behandelt wurden
  2. ECOG-Leistungsstatus von 0 oder 1
  3. Ausreichende Organfunktion
  4. Nur Teil 1b-Patienten müssen bereit sein, vor und nach Beginn der Studienbehandlung frische Tumorbiopsien bereitzustellen.

Ausschlusskriterien:

  1. Erhaltene vorherige Behandlung mit IL-2-Therapie
  2. Vorgeschichte einer klinisch signifikanten Lungenerkrankung
  3. Vorgeschichte einer klinisch signifikanten Herz-Kreislauf-Erkrankung
  4. Hat eine Diagnose von Immunschwäche
  5. Hat eine aktive Autoimmunerkrankung, die in den letzten 2 Jahren eine systemische Behandlung erfordert hat, einschließlich der Verwendung von krankheitsmodifizierenden Mitteln, Kortikosteroiden oder immunsuppressiven Medikamenten
  6. Hat eine aktive Infektion, die innerhalb von 4 Wochen vor der Studienbehandlung eine systemische Therapie erfordert

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Phase 2 XTX202 Dosiserweiterung

In Teil 2A werden Patienten mit metastasiertem Nierenzellkarzinom aufgenommen, die nach der Standardbehandlung Fortschritte gemacht haben.

In Teil 2B werden Melanompatienten aufgenommen, die nach der Standardbehandlung Fortschritte gemacht haben.
Arzneimittel: XTX202
XTX202 Monotherapie
Experimental: Phase 1 XTX202-Dosiseskalation und Erweiterung der Pharmakodynamik

Teil 1A Dosissteigerung von XTX202, verabreicht in aufsteigenden Dosen an Patienten mit fortgeschrittenen oder metastasierten soliden Tumoren, um die empfohlenen Phase-2-Dosen (RP2Ds) zu ermitteln.

Teil 1B: Bewertung von XTX202 bei Patienten mit ausgewählten fortgeschrittenen soliden Tumoren zur weiteren Charakterisierung des pharmakodynamischen Profils von XTX202
Arzneimittel: XTX202
XTX202 Monotherapie

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
Zeitfenster: Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)

All participants in Phase 1 Part 1A (Dose Escalation) who received at least 1 dose of XTX202 and experienced a DLT. DLTs were defined as the following:

  • Any treatment-related Grade ≥ 3 toxicity
  • Any Grade febrile neutropenia

  • The following nonhematologic exceptions:

    • Grade 3 nausea or vomiting lasting < 3 days
    • Grade 3 fatigue lasting < 7 days
  • Any treatment-related toxicity that resulted in a treatment delay of ≥ 7 days
Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)
Incidence of Treatment-emergent Adverse Events (Phase 1 Only)
Zeitfenster: Up to 24 months
Treatment-emergent adverse event (TEAE) is defined as any adverse event that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. Adverse events are graded using the NCI CTCAE version 5.0.
Up to 24 months
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 2 Only)
Zeitfenster: Up to 24 months

Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response is based on Investigator assessment according to RECIST v1.1.

In the analysis set used for ORR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Biochemistry
Zeitfenster: Up to 24 months
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Hematology
Zeitfenster: up to 24 months
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Thyroid Function
Zeitfenster: Up to 24 months
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 1 Only) - Coagulation
Zeitfenster: Up to 24 months
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value. Missing = number of patients with missing baseline and/or post baseline laboratory value
Up to 24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Zeitfenster: Up to 24 months
Percentage of participants who achieved at least one confirmed Complete Response (CR) or Partial Response (PR). Response will be based on Investigator's assessment according to RECIST v1.1.
Up to 24 months
Duration of Response (DOR) (Phase 2 Only)
Zeitfenster: Up to 24 months
Duration of response is defined as time from first documentation of a subsequently confirmed objective response (CR or PR) to the date of the first documentation of radiographic disease progression according to Investigator assessment by RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.
Up to 24 months
Disease Control Rate (Phase 2 Only)
Zeitfenster: Up to 24 months

Disease Control Rate (DCR) is defined as percentage of participants with confirmed BOR of CR, PR or SD (minimum duration of 6 weeks) according to RECIST v1.1, after the first dose of study treatment.

In the analysis set used for DCR, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
Up to 24 months
Overall Survival (OS) (Phase 2 Only)
Zeitfenster: Up to 24 months

OS is defined as the time from first administration of study treatment to death due to any cause. For participants without a record of death, OS will be censored at the date they were last known alive.

In the analysis set used for OS, participants are assigned to a treatment group based on the initial dose received.. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Up to 24 months
Progression-free Survival (PFS) (Phase 2 Only)
Zeitfenster: Up to 24 months

PFS is defined as the time from first administration of study treatment until first documentation of radiographic PD according to RECIST v1.1, or death due to any cause, whichever occurs first. Participants who do not have an observed documented disease progression or death from any cause will be censored at the latest tumor response assessment date.

In the analysis set used for PFS, participants are assigned to a treatment group based on the initial dose received. In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
Up to 24 months
Incidence of Treatment-emergent Adverse Events (Phase 2 Only)
Zeitfenster: Up to 24 months
Treatment-emergent adverse event is defined as any adverse event (AE) that starts or increases in severity on or after the first dose of study drug and no later than 90 days after the last dose of study drug. AEs are graded using the NCI CTCAE version 5.0.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Hematology
Zeitfenster: Up to 24 months
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Biochemistry
Zeitfenster: Up to 24 months
Number of participants that experienced a clinical laboratory test abnormality. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Laboratory data is graded using the NCI CTCAE version 5.0. Participants are included only once, in the highest level of CTCAE Grade.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Thyroid Function
Zeitfenster: Up to 24 months
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Up to 24 months
Incidence of Changes in Clinical Laboratory Values (Phase 2 Only) - Coagulation
Zeitfenster: Up to 24 months
Number of participants with shift from baseline in laboratory results. Baseline is defined as the last available measurement taken prior to the first administration of study treatment. Participants with both baseline and at least one postbaseline result are included. Participants are included only once, in the highest level of CTCAE Grade. Missing = number of patients with missing baseline and/or post baseline laboratory value.
Up to 24 months
Plasma Concentrations of Total XTX202
Zeitfenster: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1

Plasma Concentration of Total XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Plasma Concentrations of Intact XTX202
Zeitfenster: 0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1

Plasma Concentration of Intact XTX202 by Nominal Time (h) From End of Infusion Following a Single IV Administration of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
0.00, 0.0167, 0.250, 0.500, 1.50, 3.00, 24.0, 72.0, 144, 312, 504 hours post-dose following a single administration of XTX202 on Cycle 1
Total XTX202 Plasma Trough Concentration
Zeitfenster: From Cycle 1 to up to Cycle 18 (21 days per cycle)

Plasma Trough Concentration of Total XTX202 Following Multiple IV Administrations of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group
From Cycle 1 to up to Cycle 18 (21 days per cycle)
Intact XTX202 Plasma Trough Concentration
Zeitfenster: from Cycle 1 to up to Cycle 18 (21 days per cycle)

Plasma Trough Concentration of Intact XTX202 Following Multiple IV Administrations of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
from Cycle 1 to up to Cycle 18 (21 days per cycle)
Maximum Observed Plasma Concentration (Cmax) of Total XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Cmax following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Intact XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Cmax following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Total XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Time of maximum observed concentration (Tmax) of total XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Time of Maximum Observed Concentration (Tmax) of Intact XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Time of maximum observed concentration (Tmax) of intact XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Total XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Area under the curve (AUC)of total XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Area Under the Curve From Time 0 to 504 Hours (AUC0-504) of Intact XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Area under the curve (AUC) of intact XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Total XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Half-life (T1/2) of total XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Half-life (T1/2) of Intact XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Half-life (T1/2) of intact XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Total XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Systemic clearance (CL) of Total XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Systemic Clearance (CL) of Intact XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Systemic clearance (CL) of intact XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Total XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Volume of distribution (Vd) of total XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Volume of Distribution (Vd) of Intact XTX202
Zeitfenster: up to 21 days following a single IV infusion of XTX202 on Cycle 1

Volume of distribution (Vd) of intact XTX202 following a single IV infusion of XTX202.

In the analysis set used for PK, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
up to 21 days following a single IV infusion of XTX202 on Cycle 1
Antidrug Antibody (ADA) Occurrence and Titer in Serum (Phase 1 Only)
Zeitfenster: from Cycle 1 Day 1 to up to 24 months

Overall ADA Incidence Following a Single IV Administration of XTX202

In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 1 Part 1B initially received XTX202 2.8 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
from Cycle 1 Day 1 to up to 24 months
Incidence and Persistence of ADAs (Including Neutralizing ADAs) and Titers (Phase 2 Only)
Zeitfenster: From Cycle 1 Day 1 to up to 24 months

Overall ADA Incidence Following a Single IV Administration of XTX202.

In the analysis set used for ADA, participants are assigned to a treatment group based on the initial dose received.

In the Participant Flow module, participants are assigned to a treatment group based on the highest dose received. One participant in Phase 2 Part 2B initially received XTX202 1.4 mg/kg, then increased the dose to 4.0 mg/kg at a later cycle and was therefore included in the XTX202 4.0 mg/kg dose group.
From Cycle 1 Day 1 to up to 24 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Xilio Development, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Januar 2022

Primärer Abschluss (Tatsächlich)

22. März 2025

Studienabschluss (Tatsächlich)

25. März 2025

Studienanmeldedaten

Zuerst eingereicht

23. August 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. September 2021

Zuerst gepostet (Tatsächlich)

22. September 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. April 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • XTX202-01/02-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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