Informations générales (source: ClinicalTrials.gov)
A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Interventional
Phase 1
Incyte Corporation (Voir sur ClinicalTrials)
juillet 2023
janvier 2027
02 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 27/04/2026 07:55:05 | Contacter | ||
Critères
Tous
- ≥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.