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XTX202 hos patienter med avancerede solide tumorer

30. april 2026 opdateret af: Xilio Development, Inc.

Et første-i-menneskeligt, multicenter, fase 1/2, åbent studie af XTX202 i patienter med avancerede solide tumorer

Et første-i-menneskeligt, multicenter, fase 1/2, åbent studie af XTX202 i patienter med avancerede solide tumorer

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et første-i-menneske, fase 1/2, multicenter, åbent studie designet til at evaluere sikkerheden, tolerabiliteten og effektiviteten af ​​XTX202, et konstrueret IL-2 prodrug med dets aktivitet maskeret, som monoterapi hos patienter med fremskreden solide tumorer.

Fase 1, del 1a, vil undersøge XTX202 monoterapi i et accelereret og standard 3+3 dosis-eskaleringsdesign. Baseret på resultaterne af del 1a vil del 1b blive igangsat for yderligere at undersøge XTX202 hos patienter med udvalgte fremskredne solide tumorer og for yderligere at karakterisere XTX202.

Baseret på resultaterne af fase 1-patienter med udvalgte fremskredne solide tumorer vil blive indskrevet i fase 2.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

95

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Sygdomskriterier

    • Fase 1, del 1a: Enhver histologisk eller cytologisk bekræftet solid tumor malignitet, der er lokalt fremskreden eller metastatisk og har mislykket standardbehandling, eller standardterapi er ikke helbredende eller tilgængelig
    • Fase 1, del 1b: Histologisk eller cytologisk bekræftet malignitet i solid tumor med en af ​​følgende tumorhistologier: RCC af kun klarcellet histologi, melanom, pladecellehudcarcinom, ovariecancer, ikke-småcellet lungecancer. Patienter skal have været behandlet med tilgængelig standardterapi. De patienter, der tidligere har modtaget immunterapi, skal have haft gavn af denne behandling. Derudover kan patienter med en af ​​ovenstående histologier i en avanceret indstilling, som planlægger at gennemgå debulking-kirurgi eller oligometastasektomi, være berettiget til at modtage 2 cyklusser af XTX202-behandling i en "vindue af muligheder"-underkohorte.
    • Fase 2, del 2a: Patienter med metastatisk RCC, som tidligere er blevet behandlet med en godkendt anti-PD-1 og en TKI. Patienter skal være gået videre med behandling med en anti-PD-1 mAb administreret enten som monoterapi eller i kombination med andre behandlinger
    • Fase 2, del 2b: Patienter med uoperabelt eller metastatisk melanom, som tidligere er blevet behandlet med en godkendt anti-PD-1 og en anti-CTLA4 checkpoint hæmmer
  2. ECOG-ydelsesstatus på 0 eller 1
  3. Tilstrækkelig organfunktion
  4. Kun del 1b patienter skal være villige til at give friske tumorbiopsier før og efter påbegyndelse af undersøgelsesbehandling.

Ekskluderingskriterier:

  1. Modtaget tidligere behandling med IL-2 terapi
  2. Anamnese med klinisk signifikant lungesygdom
  3. Anamnese med klinisk signifikant kardiovaskulær sygdom
  4. Har diagnosen immundefekt
  5. Har en aktiv autoimmun sygdom, der har krævet systemisk behandling i de sidste 2 år, inklusive brug af sygdomsmodificerende midler, kortikosteroider eller immunsuppressive lægemidler
  6. Har en aktiv infektion, der kræver systemisk behandling inden for 4 uger før studiebehandling

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fase 2 XTX202 Dosisudvidelse

Del 2A vil inkludere patienter med metastatisk nyrecellecarcinom, som har udviklet sig efter standardbehandling.

Del 2B vil inkludere patienter med melanom, som har udviklet sig efter standardbehandling.
Medicin: XTX202
XTX202 Monoterapi
Eksperimentel: Fase 1 XTX202 dosiseskalering og farmakodynamikudvidelse

Del 1A Dosiseskalering af XTX202 administreret i stigende doser til patienter med fremskredne eller metastatiske solide tumorer for at finde de anbefalede fase 2-doser (RP2D'er).

Del 1B Evaluering af XTX202 hos patienter med udvalgte fremskredne solide tumorer for yderligere at karakterisere den farmakodynamiske profil af XTX202
Medicin: XTX202
XTX202 Monoterapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xilio Development, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. januar 2022

Primær færdiggørelse (Faktiske)

22. marts 2025

Studieafslutning (Faktiske)

25. marts 2025

Datoer for studieregistrering

Først indsendt

23. august 2021

Først indsendt, der opfyldte QC-kriterier

10. september 2021

Først opslået (Faktiske)

22. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XTX202-01/02-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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