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XTX202 u pacientů s pokročilými solidními nádory

30. dubna 2026 aktualizováno: Xilio Development, Inc.

První, multicentrická, otevřená studie fáze 1/2 u člověka s XTX202 u pacientů s pokročilými solidními nádory

První, multicentrická, otevřená studie fáze 1/2 u člověka s XTX202 u pacientů s pokročilými solidními nádory

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Toto je první u člověka, fáze 1/2, multicentrická, otevřená studie navržená k vyhodnocení bezpečnosti, snášenlivosti a účinnosti XTX202, umělého proléčiva IL-2 s maskovanou aktivitou, jako monoterapie u pacientů s pokročilým solidní nádory.

Fáze 1, část 1a, bude zkoumat monoterapii XTX202 v akcelerovaném a standardním designu 3+3 eskalace dávky. Na základě výsledků části 1a bude zahájena část 1b k dalšímu zkoumání XTX202 u pacientů s vybranými pokročilými solidními nádory a k další charakterizaci XTX202.

Na základě výsledků fáze 1 budou pacienti s vybranými pokročilými solidními nádory zařazeni do fáze 2.

Typ studie

Intervenční

Zápis (Aktuální)

95

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  1. Kritéria onemocnění

    • Fáze 1, část 1a: Jakákoli histologicky nebo cytologicky potvrzená malignita solidního nádoru, která je lokálně pokročilá nebo metastatická a selhala standardní terapií, nebo standardní terapie není kurativní nebo dostupná
    • Fáze 1, část 1b: Histologicky nebo cytologicky potvrzená malignita solidního tumoru s jednou z následujících histologií tumoru: RCC pouze histologie z jasných buněk, melanom, spinocelulární karcinom kůže, karcinom vaječníků, nemalobuněčný karcinom plic. Pacienti musí být léčeni dostupnou standardní terapií. Pacienti, kteří dříve dostávali imunoterapii, musí mít z této léčby prospěch. Navíc pacienti s kteroukoli z výše uvedených histologií v pokročilém nastavení, kteří plánují podstoupit debulkingovou operaci nebo oligometastasektomii, mohou mít nárok na 2 cykly léčby XTX202 v podkohortě „okno příležitosti“.
    • Fáze 2, část 2a: Pacienti s metastatickým RCC, kteří byli dříve léčeni schváleným anti-PD-1 a TKI. Pacienti museli progredovat při léčbě anti-PD-1 mAb podávanou buď jako monoterapie, nebo v kombinaci s jinými terapiemi
    • Fáze 2, část 2b: Pacienti s neresekovatelným nebo metastatickým melanomem, kteří byli dříve léčeni schváleným anti-PD-1 a anti-CTLA4 inhibitorem kontrolního bodu
  2. Stav výkonu ECOG 0 nebo 1
  3. Přiměřená funkce orgánů
  4. Pouze pacienti podle části 1b musí být ochotni poskytnout čerstvé biopsie nádoru před a po zahájení studijní léčby.

Kritéria vyloučení:

  1. Absolvoval předchozí léčbu IL-2 terapií
  2. Anamnéza klinicky významného plicního onemocnění
  3. Anamnéza klinicky významného kardiovaskulárního onemocnění
  4. Má diagnózu imunodeficience
  5. Má aktivní autoimunitní onemocnění, které v posledních 2 letech vyžadovalo systémovou léčbu, včetně užívání látek modifikujících onemocnění, kortikosteroidů nebo imunosupresiv
  6. Má aktivní infekci vyžadující systémovou léčbu během 4 týdnů před studijní léčbou

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Fáze 2 Rozšíření dávky XTX202

Část 2A zahrne pacienty s metastatickým karcinomem ledviny, kteří po standardní péči progredovali.

Část 2B bude zahrnovat pacienty s melanomem, kteří po standardní péči progredovali.
Lék: XTX202
Monoterapie XTX202
Experimentální: Fáze 1 Eskalace dávky XTX202 a expanze farmakodynamiky

Část 1A Eskalace dávky XTX202 podávaného ve vzestupných dávkách pacientům s pokročilými nebo metastatickými solidními nádory za účelem nalezení doporučených dávek fáze 2 (RP2D).

Část 1B Hodnocení XTX202 u pacientů s vybranými pokročilými solidními nádory za účelem další charakterizace farmakodynamického profilu XTX202
Lék: XTX202
Monoterapie XTX202

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Xilio Development, Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. ledna 2022

Primární dokončení (Aktuální)

22. března 2025

Dokončení studie (Aktuální)

25. března 2025

Termíny zápisu do studia

První předloženo

23. srpna 2021

První předloženo, které splnilo kritéria kontroly kvality

10. září 2021

První zveřejněno (Aktuální)

22. září 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. dubna 2026

Naposledy ověřeno

1. března 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • XTX202-01/02-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Pokročilý pevný nádor

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in South Africa

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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