A Phase I, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Study Identifier:
INCA33890-101
CT.gov Identifier:
NCT05836324
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
2022-502456-31-00
Study Contact Information:
N/A
Recruiting

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Study Summary

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.

To evaluate INCA033890 in Participants with Advanced or Metastatic Solid Tumors

To evaluate the safety, tolerability, dose-limiting toxicities (DLTs), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of INCA33890 when administered as a monotherapy and in combination with other standard-of-care treatments (i.e., bevacizumab, bevacizumab and FOLFIRI, bevacizumab and FOLFOX, and cetuximab) in adults (≥18 years old) with advanced or metastatic solid tumors.

The study includes Part 1 evaluating INCA33890 as a monotherapy with Part 1A (dose escalation) and Part 1B (dose expansion). Inclusion criteria for Part 1 requires patients to have experienced disease progression after receiving available therapies or that they were intolerant to, ineligible for or declined standard treatment. Part 2 will evaluate INCA33890 administered in combination with other protocol-defined treatment(s) based on cohort assignment and also includes dose escalation (Part 2A) and dose expansion (Part 2B).

Part 1a (dose escalation) evaluated safety, PK, PD and preliminary efficacy to determine recommended doses for expansion (RDEs). Part 1b (dose expansion) assessed RDEs in select tumours

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1a - Dose Escalation
    • Read More
  • Drug: Experimental: Part 1b-Dose Expansion
  • Drug: Experimental: Part 2a - Dose Escalation Combination Therapy - Group 1
  • Drug: Drug: bevacizumab
  • Drug: Experimental: Part 2a - Dose Escalation Combination Therapy - Group 2
  • Drug: Drug: FOLFIRI
  • Drug: Experimental: Part 2a - Dose Escalation Combination Therapy - Group 3
  • Drug: Drug: FOLFOX
  • Drug: Experimental: Part 2a - Dose Escalation Combination Therapy - Group 4
  • Drug: Drug: Cetuximab
  • Drug: Experimental: Part 2b - Dose Expansion Combination Therapy - Group 1
  • Drug: Experimental: Part 2b - Dose Expansion Combination Therapy - Group 2
  • Drug: Experimental: Part 2b - Dose Expansion Combination Therapy - Group 3
  • Drug: Experimental: Part 2b - Dose Expansion Combination Therapy - Group 4
  • Drug: Patients received doses of INCA33890 ranging from 100 mg to 1,500 mg every two weeks (Q2W) to 900 mg intravenously (IV) every four weeks (Q4W) in continuous 28-day cycles. INCA33890 300 mg, 600 mg and 900 mg Q2W were selected as the recommended doses for expansion (RDE).
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • ≥18 years old
    • Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.
    • Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study.
    • ECOG performance status score of 0 or 1.
    • Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts.
    • Presence of measurable disease according to RECIST v1.1.
    • Jrct
    • 1. >=18 years old
    • 2. Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.
    • 3. Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study.
    • 4. ECOG performance status score of 0 or 1.
    • 5. Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts.
    • 6. Presence of measurable disease according to RECIST v1.1
    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.
    • Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.
    • Brain or CNS metastases untreated or that have progressed.
    • History of organ transplant, including allogeneic stem cell transplantation.
    • History of clinically significant or uncontrolled cardiac disease.
    • Active HBV, active HCV, or HIV positive.
    • Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent).
    • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
    • Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.
    • Significant concurrent, uncontrolled medical condition, eg:
    • Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis.
    • Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1.
    • Participants with adequate laboratory values within the protocol defined ranges.
    • Jrct
    • 1. Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years.
    • 2. Not recovered to <= Grade 1 or baseline from residual toxicities of prior therapy.
    • 3. Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.
    • 4. Brain or CNS metastases untreated or that have progressed.
    • 5. History of organ transplant, including allogeneic stem cell transplantation.
    • 6. History of clinically significant or uncontrolled cardiac disease.
    • 7. Active HBV, active HCV, or HIV positive.
    • 8. Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent).
    • 9. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
    • 10. Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.
    • 11. Significant concurrent, uncontrolled medical condition, eg:
    • Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis.
    • 12. Participants with adequate laboratory values within the protocol defined ranges.
    • Other protocol-defined Inclusion/Exclusion Criteria may apply.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor