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INCA 33890-101

A study to evaluate the safety of inca33890 in participants with advanced or metastatic solid tumors
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05836324
Solid Tumors
INCA33890
Source : Importé depuis le centre
Recrutement partiellement ouvert
Dernière modification : 2025/05/05
Type de recherche

Interventionnel

Médicament expérimental

PHASE1


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

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.

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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Part 1a - Dose Escalation Monotherapy INCA33890 will be administered at the protocol-defined dose based on cohort assignment. Donnée non disponible
  • Inconnu
  • Part 1b-Dose Expansion Monotherapy INCA33890 will be administered at the protocol-defined dose based on cohort assignment. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • 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. Donnée non disponible
  • Inconnu
  • Part 1a - Dose Escalation Monotherapy
    État du recrutement
    unknown
    Part 1b-Dose Expansion Monotherapy
    État du recrutement
    unknown
    Part 2a - Dose Escalation Combination Therapy - Group 1
    État du recrutement
    unknown
    Part 2a - Dose Escalation Combination Therapy - Group 2
    État du recrutement
    unknown
    Part 2a - Dose Escalation Combination Therapy - Group 3
    État du recrutement
    unknown
    Part 2a - Dose Escalation Combination Therapy - Group 4
    État du recrutement
    unknown
    Part 2b - Dose Expansion Combination Therapy - Group 1
    État du recrutement
    unknown
    Part 2b - Dose Expansion Combination Therapy - Group 2
    État du recrutement
    unknown
    Part 2b - Dose Expansion Combination Therapy - Group 3
    État du recrutement
    unknown
    Part 2b - Dose Expansion Combination Therapy - Group 4
    État du recrutement
    unknown
    Données à jour depuis : 5 mai 2025

    Description de l'étude

    Résumé de l'étude

    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.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 5 mai 2025
    Données à jour depuis : 7 mai
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05836324