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XTX202 u pacjentów z zaawansowanymi guzami litymi

30 kwietnia 2026 zaktualizowane przez: Xilio Development, Inc.

Pierwsze u ludzi, wieloośrodkowe, otwarte badanie fazy 1/2 dotyczące XTX202 u pacjentów z zaawansowanymi guzami litymi

Pierwsze u ludzi, wieloośrodkowe, otwarte badanie fazy 1/2 dotyczące XTX202 u pacjentów z zaawansowanymi guzami litymi

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Jest to pierwsze wieloośrodkowe, otwarte badanie fazy 1/2 z udziałem ludzi, mające na celu ocenę bezpieczeństwa, tolerancji i skuteczności XTX202, zmodyfikowanego proleku IL-2 z zamaskowaną aktywnością, w monoterapii u pacjentów z zaawansowaną guzy lite.

Faza 1 Część 1a zbada monoterapię XTX202 w przyspieszonym i standardowym schemacie zwiększania dawki 3+3. W oparciu o wyniki części 1a, część 1b zostanie zainicjowana w celu dalszego zbadania XTX202 u pacjentów z wybranymi zaawansowanymi guzami litymi i dalszego scharakteryzowania XTX202.

Na podstawie wyników fazy 1 pacjenci z wybranymi zaawansowanymi guzami litymi zostaną włączeni do fazy 2.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

95

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  1. Kryteria choroby

    • Faza 1, część 1a: Każdy potwierdzony histologicznie lub cytologicznie nowotwór lity, który jest miejscowo zaawansowany lub z przerzutami i którego standardowe leczenie nie powiodło się lub standardowa terapia nie pozwala na wyleczenie lub jest niedostępna
    • Faza 1, część 1b: histologicznie lub cytologicznie potwierdzony nowotwór lity z jednym z następujących typów histologicznych: RCC wyłącznie o histologii jasnokomórkowej, czerniak, rak płaskonabłonkowy skóry, rak jajnika, niedrobnokomórkowy rak płuca. Pacjenci musieli być leczeni dostępną standardową terapią. Pacjenci, którzy wcześniej otrzymywali immunoterapię, musieli odnieść korzyści z tego leczenia. Dodatkowo, pacjenci z którąkolwiek z powyższych histologii w zaawansowanym stadium, którzy planują poddać się operacji odciążenia lub oligometastazektomii, mogą kwalifikować się do otrzymania 2 cykli leczenia XTX202 w subkohorcie „okna możliwości”.
    • Faza 2, część 2a: Pacjenci z rakiem nerkowokomórkowym z przerzutami, którzy byli wcześniej leczeni zatwierdzonym lekiem anty-PD-1 i TKI. Pacjenci muszą mieć progresję podczas leczenia mAb anty-PD-1 podawanego w monoterapii lub w połączeniu z innymi terapiami
    • Faza 2, część 2b: Pacjenci z czerniakiem nieoperacyjnym lub z przerzutami, którzy byli wcześniej leczeni zatwierdzonym inhibitorem punktu kontrolnego anty-PD-1 i anty-CTLA4
  2. Stan wydajności ECOG 0 lub 1
  3. Odpowiednia funkcja narządów
  4. Tylko część 1b Pacjenci muszą być chętni do dostarczenia świeżych biopsji guza przed i po rozpoczęciu leczenia w ramach badania.

Kryteria wyłączenia:

  1. Otrzymał wcześniejsze leczenie terapią IL-2
  2. Historia klinicznie istotnej choroby płuc
  3. Historia klinicznie istotnej choroby sercowo-naczyniowej
  4. Ma rozpoznanie niedoboru odporności
  5. Ma czynną chorobę autoimmunologiczną, która wymagała leczenia ogólnoustrojowego w ciągu ostatnich 2 lat, w tym stosowania środków modyfikujących przebieg choroby, kortykosteroidów lub leków immunosupresyjnych
  6. Ma aktywną infekcję wymagającą leczenia ogólnoustrojowego w ciągu 4 tygodni przed leczeniem w ramach badania

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Faza 2 Rozszerzenie dawki XTX202

Część 2A obejmie pacjentów z rakiem nerkowokomórkowym z przerzutami, u których doszło do progresji po standardowym leczeniu.

Część 2B obejmie pacjentów z czerniakiem, u których doszło do progresji po standardowym leczeniu.
Lek: XTX202
Monoterapia XTX202
Eksperymentalny: Faza 1 XTX202 Eskalacja dawki i rozszerzenie farmakodynamiki

Część 1A Zwiększanie dawki XTX202 podawanego w rosnących dawkach pacjentom z zaawansowanymi lub przerzutowymi guzami litymi w celu znalezienia zalecanych dawek fazy 2 (RP2D).

Część 1B Ocena XTX202 u pacjentów z wybranymi zaawansowanymi guzami litymi w celu dalszego scharakteryzowania profilu farmakodynamicznego XTX202
Lek: XTX202
Monoterapia XTX202

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Xilio Development, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 stycznia 2022

Zakończenie podstawowe (Rzeczywisty)

22 marca 2025

Ukończenie studiów (Rzeczywisty)

25 marca 2025

Daty rejestracji na studia

Pierwszy przesłany

23 sierpnia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 września 2021

Pierwszy wysłany (Rzeczywisty)

22 września 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 kwietnia 2026

Ostatnia weryfikacja

1 marca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • XTX202-01/02-001

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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