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Tests treatment safety and results for Solid Tumors
Official title A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05836324
What this study is testing
What is INCA33890?
INCA33890 is an investigational medicine, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Hackensack, New Jersey, United States
- Mineola, New York, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Beijing, China
- Hangzhou, China
- Copenhagen, Denmark
- Herlev, Denmark
- Odense C, Denmark
- Vejle, Denmark
- Lyon, France
- Villejuif, France
- Milan, Italy
- Rozzano, Italy
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; Hackensack, New Jersey, United States; Mineola, New York, United States; New York, New York, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.