UPCC 08925 A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Study of Investigational Medication in Patients with Advanced Cancers that Form in Organs or Tissues
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors
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Age: 18 years or above
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Gender: All
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.
This study investigates an investigational medication in patients with advanced or metastatic solid tumors. The purpose of the study is to evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of the investigational medication. The study will also determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in these patients.
Participants in this study will undergo various procedures, including pre-treatment and on-treatment tumor biopsies to assess the investigational medication's effects. Biopsies involve taking small samples of the tumor tissue for examination. The study requires participants to have measurable disease according to specific criteria and to have undergone or be ineligible for standard treatments. Participants will be closely monitored for any side effects or changes in their condition.
- Who can participate: Adults aged 18 and older with advanced or metastatic cancers confirmed through tests can participate. They must have experienced disease progression after standard treatments or be ineligible for such treatments and have a score indicating minimal impact on daily activities.
- Study details: Participants will receive the investigational medication and undergo tumor biopsies to assess its effects. They must have measurable disease and meet specific health criteria. The study will monitor the safety and tolerability of the investigational medication.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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