Study on RAS(ON) Inhibitors with Ivonescimab for Patients with Solid Tumors
Sponsor: Revolution Medicines, Inc.
ClinicalTrials ID:NCT07397338
This clinical trial is testing the safety and effectiveness of combining RAS(ON) inhibitors with ivonescimab in adults who have advanced solid tumors with a RAS mutation. The study aims to find out how well this combination works against cancer and how the body processes the drugs.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is designed to evaluate a new treatment approach using RAS(ON) inhibitors combined with ivonescimab for adults with advanced or metastatic solid tumors that have a RAS mutation. Researchers want to understand the safety, how the drugs are tolerated, and their initial effectiveness in fighting cancer. The study includes three different treatment groups, each testing a different RAS(ON) inhibitor with ivonescimab. The study will explore the best dose and how well the treatment works in shrinking tumors.
Description
This clinical trial is open to adults with advanced solid tumors that have a specific RAS mutation. The study is divided into two main parts. In the first part, researchers will test different doses of RAS(ON) inhibitors combined with ivonescimab to see how safe and tolerable they are. In the second part, they will expand the study to see how effective these combinations are in treating cancer. There are three groups in the study, each testing a different RAS(ON) inhibitor with ivonescimab. Some groups may also include other cancer treatments. Participants will receive the study drugs and undergo regular health checks to monitor their response and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and agree to participate.
- Have a good overall health status, able to carry out daily activities.
- Have a confirmed diagnosis of advanced or metastatic solid tumor with a RAS mutation.
- Have tried standard treatments before and either did not respond or could not tolerate them.
- For certain groups, have non-squamous non-small cell lung cancer (NSCLC) without other treatable mutations and have not received prior treatment.
- For other groups, have a solid tumor or colorectal cancer (CRC) treated with no more than two prior therapies and did not respond or could not tolerate them.
- Have measurable cancer that can be tracked during the study.
- Have good organ function, including bone marrow, liver, and kidneys.
- Be able to take oral medications.
Exclusion Criteria
- Have head and neck squamous cell carcinoma.
- Have any conditions that affect the ability to take or absorb the study drugs.
- Have had major surgery within four weeks before starting the study drugs.
- Are unable or unwilling to attend study visits or follow study procedures.
- Other criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Eastern Connecticut Hematology and Oncology Associates | 06360 | Norwich | Connecticut |
| Tennessee Oncology | 37023 | Nashville | Tennessee |
| NEXT Dallas | 75039 | Irving | Texas |
| NEXT Oncology | 78229 | San Antonio | Texas |
| NEXT Virginia | 22031 | Fairfax | Virginia |
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