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XTX202 potilailla, joilla on edennyt kiinteitä kasvaimia

torstai 30. huhtikuuta 2026 päivittänyt: Xilio Development, Inc.

Ensimmäinen ihmisessä, monikeskus, vaihe 1/2, avoin tutkimus XTX202:sta potilailla, joilla on kehittyneitä kiinteitä kasvaimia

Ensimmäinen ihmisessä, monikeskus, vaihe 1/2, avoin tutkimus XTX202:sta potilailla, joilla on kehittyneitä kiinteitä kasvaimia

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Tämä on ensimmäinen ihmisissä, vaiheen 1/2, monikeskustutkimus, avoin tutkimus, jonka tarkoituksena on arvioida XTX202:n turvallisuutta, siedettävyyttä ja tehoa. XTX202 on suunniteltu IL-2-aihiolääke, jonka aktiivisuus on peitetty, monoterapiana potilailla, joilla on pitkälle edennyt. kiinteät kasvaimet.

Vaiheen 1 osassa 1a tarkastellaan XTX202-monoterapiaa nopeutetussa ja standardinmukaisessa 3+3 annoskorotussuunnitelmassa. Osan 1a tulosten perusteella aloitetaan osa 1b XTX202:n tutkimiseksi edelleen potilailla, joilla on valikoituja edenneitä kiinteitä kasvaimia, ja XTX202:n karakterisoimiseksi edelleen.

Vaiheen 1 tulosten perusteella potilaat, joilla on valikoituja pitkälle edenneitä kiinteitä kasvaimia, otetaan mukaan vaiheeseen 2.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

95

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  1. Sairauden kriteerit

    • Vaihe 1, osa 1a: Mikä tahansa histologisesti tai sytologisesti vahvistettu kiinteä kasvain pahanlaatuinen kasvain, joka on paikallisesti edennyt tai metastaattinen ja jonka standardihoito on epäonnistunut tai standardihoito ei ole parantavaa tai saatavilla
    • Vaihe 1, osa 1b: Histologisesti tai sytologisesti vahvistettu kiinteä kasvain pahanlaatuinen syöpä, jolla on jokin seuraavista kasvainhistologioista: vain selkeä soluhistologia, melanooma, levyepiteelisyöpä, munasarjasyöpä, ei-pienisoluinen keuhkosyöpä. Potilaita on hoidettu saatavilla olevalla standardihoidolla. Aiemmin immunoterapiaa saaneiden potilaiden on täytynyt hyötyä tästä hoidosta. Lisäksi potilaat, joilla on jokin edellä mainituista histologioista edistyneessä ympäristössä ja jotka suunnittelevat poistoleikkausta tai oligometastasektomiaa, voivat olla oikeutettuja saamaan 2 XTX202-hoitosykliä "mahdollisuuksien ikkunan" alakohortissa.
    • Vaihe 2, osa 2a: Potilaat, joilla on metastaattinen RCC ja joita on aiemmin hoidettu hyväksytyllä anti-PD-1:llä ja TKI:llä. Potilaiden on täytynyt olla edennyt anti-PD-1-mAb-hoidossa joko monoterapiana tai yhdessä muiden hoitojen kanssa
    • Vaihe 2, osa 2b: Potilaat, joilla on leikkauskelvoton tai metastaattinen melanooma, joita on aiemmin hoidettu hyväksytyllä anti-PD-1- ja anti-CTLA4-tarkistuspisteestäjillä
  2. ECOG-suorituskykytila ​​on 0 tai 1
  3. Riittävä elinten toiminta
  4. Ainoastaan ​​osan 1b potilaiden on oltava valmiita toimittamaan tuoreet kasvainbiopsiat ennen tutkimushoidon aloittamista ja sen jälkeen.

Poissulkemiskriteerit:

  1. Sai aiempaa hoitoa IL-2-hoidolla
  2. Kliinisesti merkittävä keuhkosairaus historiassa
  3. Aiemmin kliinisesti merkittävä sydän- ja verisuonisairaus
  4. Hänellä on diagnoosi immuunipuutos
  5. Hänellä on aktiivinen autoimmuunisairaus, joka on vaatinut systeemistä hoitoa viimeisen 2 vuoden aikana, mukaan lukien sairautta modifioivien aineiden, kortikosteroidien tai immunosuppressiivisten lääkkeiden käyttö
  6. Hänellä on aktiivinen infektio, joka vaatii systeemistä hoitoa 4 viikon sisällä ennen tutkimushoitoa

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Peräkkäinen tehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Vaihe 2 XTX202-annoksen laajennus

Osaan 2A otetaan potilaat, joilla on etäpesäkkeinen munuaissyöpä ja jotka ovat edenneet tavanomaisen hoidon jälkeen.

Osaan 2B otetaan mukaan melanoomapotilaita, jotka ovat edenneet tavanomaisen hoidon jälkeen.
Lääke: XTX202
XTX202 monoterapia
Kokeellinen: Vaihe 1 XTX202-annoksen nostaminen ja farmakodynamiikan laajentaminen

Osa 1A XTX202:n annoksen nostaminen nousevina annoksina potilaille, joilla on edennyt tai metastaattinen kiinteä kasvain, jotta löydettäisiin suositellut vaiheen 2 annokset (RP2D).

Osa 1B XTX202:n arviointi potilailla, joilla on valittu pitkälle edennyt kiinteä kasvain XTX202:n farmakodynaamisen profiilin karakterisoimiseksi edelleen
Lääke: XTX202
XTX202 monoterapia

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A Only)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Investigator-assessed Objective Response Rate (ORR) Per RECIST 1.1 (Phase 1 Only)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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

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Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • XTX202-01/02-001

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