Advanced/Metastatic

A study to evaluate the safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Incyte Study ID:
INCA 33890-101
CT.gov ID:
NCT05836324
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCA33890
  • Drug: bevacizumab
  • Drug: FOLFIRI
  • Drug: FOLFOX
  • Drug: Cetuximab
    • COLLABORATORS
    N/A
    DATE
    Jul 2023 - Jan 2027
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS (CHUV)
    LAUSANNE, Switzerland, 01011
    Status
    Recruiting
    Location
    CANCER AND HEMATOLOGY CENTERS OF WESTERN MICHIGAN-START MIDWEST
    GRAND RAPIDS, MI, US, 49546
    Status
    Recruiting
    Location
    ISTITUTO ONCOLOGICO DELLA SVIZZERA ITALIANA
    BELLINZONA, Switzerland, 06500
    Status
    Recruiting
    Location
    KANTONSSPITAL ST. GALLEN
    ST. GALLEN, Switzerland, 09007
    Status
    Recruiting
    Location
    RIGSHOSPITALET UNI OF HOSPITAL OF COPENHAGEN
    COPENHAGEN, Denmark, 02100
    Status
    Recruiting
    Location
    ODENSE UNIVERSITY HOSPITAL
    ODENSE C, Denmark, 05000
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • ≥18 years old
    • Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.

    Exclusion Criteria

    • Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years.
    • Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.

    Protocol Summary

    Incyte Study ID:
    INCA 33890-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    408
    Primary Outcome
    Open

    Dose Limiting Toxicities (DLTs)

    Timeframe: Up to 28 days

    Treatment Emerging Adverse Events (TEAEs)

    Timeframe: Up to 2 years

    TEAEs leading to dose modification or discontinuation

    Timeframe: Up to 2 years

    Secondary Outcome
    Open

    Objective response Rate

    Timeframe: 2 years

    Disease Control Rate

    Timeframe: 2 years

    Duration of Response

    Timeframe: 2 years

    Pharmacokinetics Parameter : Cmax of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

    Pharmacokinetics Parameter : Tmax of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

    Pharmacokinetics Parameter : Cmin of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

    Pharmacokinetics Parameter : AUC(0-t) of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

    Pharmacokinetics Parameter : AUC 0-∞ of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

    Pharmacokinetics Parameter : CL of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

    Pharmacokinetics Parameter : Vz of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

    Pharmacokinetics Parameter : t1/2 of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up