A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Incyte Corporation
Study ID
NCT05836324
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • Metastatic Solid Tumors
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCA33890 — DRUG
    INCA33890 will be administered at protocol defined dose.
  • bevacizumab — DRUG
    Bevacizumab will be administered at protocol defined dose.
  • FOLFIRI — DRUG
    FOLFIRI will be administered at protocol defined dose.
  • FOLFOX — DRUG
    FOLFOX will be administered at protocol defined dose.
  • Cetuximab — DRUG
    Cetuximab will be administered at protocol defined dose.

Study Details

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.

Key Dates

Start date
Jul 24, 2023
Status verified
Dec 2025
Primary completion
Jan 13, 2027
Completion
Jan 13, 2027

Study Design

Enrollment
408 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a - Dose Escalation Monotherapy
    INCA33890 will be administered at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 1b-Dose Expansion Monotherapy
    INCA33890 will be administered at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2a - Dose Escalation Combination Therapy - Group 1
    INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2a - Dose Escalation Combination Therapy - Group 2
    INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2a - Dose Escalation Combination Therapy - Group 3
    INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2a - Dose Escalation Combination Therapy - Group 4
    INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2b - Dose Expansion Combination Therapy - Group 1
    INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2b - Dose Expansion Combination Therapy - Group 2
    INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2b - Dose Expansion Combination Therapy - Group 3
    INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
  • Experimental: Part 2b - Dose Expansion Combination Therapy - Group 4
    INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.

Primary Outcome Measure

Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Cancer and Hematology Centers of Western Michigan-Start MidwestGrand RapidsMichigan49546-
Hackensack University Medical CenterHackensackNew Jersey07601-
Nyu Langone Health - Long Island HospitalMineolaNew York11501-
Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Lifespan Cancer Research InstituteProvidenceRhode Island02903-
University of Texas Md Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute· Los Angeles, CAValkyrie Clinical Trials· Los Angeles, CADana Farber Cancer Institute· Boston, MACancer and Hematology Centers of Western Michigan-Start Midwest· Grand Rapids, MIHackensack University Medical Center· Hackensack, NJNyu Langone Health - Long Island Hospital· Mineola, NY

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