Study of IDE849 for Patients with DLL3 Expressing Tumors, Including Small Cell Lung Cancer
Sponsor: IDEAYA Biosciences
ClinicalTrials ID:NCT07174583
This clinical trial is testing a new drug, IDE849, to see if it is safe and effective for patients with tumors that express DLL3, including small cell lung cancer (SCLC).
Patient Parameters
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Program Overview
This study is in two parts. The first part (Phase 1) will test different doses of IDE849 to find the highest dose that patients can safely tolerate. The second part (Phase 2) will focus on finding the best dose to use in future studies. The study will also look at how the drug is processed in the body and its effects on the immune system.
Description
The study is divided into two phases:
- Phase 1 (Dose Escalation): Patients will receive increasing doses of IDE849 to determine the maximum dose that can be safely given.
- Phase 2 (Dose Optimization/Expansion): Patients will receive one of the doses identified in Phase 1 to find the most effective dose.
The study will take place at multiple centers and will involve patients with DLL3-expressing tumors, including small cell lung cancer. Researchers will monitor the safety and effectiveness of IDE849, as well as how the body processes the drug and its impact on the immune system.
Eligibility Criteria
Inclusion Criteria
- Willing to participate and able to sign a consent form.
- Diagnosed with small cell lung cancer that has returned or progressed after standard treatments, including platinum-based therapy and certain immunotherapies, unless unsuitable for immunotherapy.
- No more than two previous chemotherapy treatments and no more than three total treatments for recurrent or metastatic cancer.
- Willing to provide blood or tumor samples for testing.
- Have at least one tumor that can be measured by scans.
- In good general health with a performance status score of 0 or 1.
- Expected to live more than 3 months.
- Have adequate bone marrow and organ function.
- Women of childbearing age must agree to use effective birth control.
Exclusion Criteria
- Have a mix of small cell and non-small cell lung cancer, except for certain types.
- Have untreated or active brain tumors.
- Have severe heart or blood vessel disease.
- Have had significant bleeding in the last 3 months.
- Have lung diseases affecting breathing or a history of lung inflammation from previous treatments.
- Have had severe infections in the last 4 weeks.
- Have a history of immune system deficiency or positive HIV test.
- Have known or suspected hepatitis infection.
- Have had active tuberculosis in the last year.
- Have received certain cancer treatments recently.
- Have taken certain medications that affect drug processing in the body recently.
- Have had previous treatment with DLL3 ADC or certain other cancer drugs.
- Have had recent high-dose radiation therapy.
- Have had major surgery or significant injury in the last 4 weeks.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study and for 8 months after the last dose.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | 80218 | Denver | Colorado |
| The University of Chicago Medical Center - Duchossois Center for Advanced Medicine | 60637 | Chicago | Illinois |
| The Cancer and Hematology Centers | 49546 | Grand Rapids | Michigan |
| Columbia University Medical Center - Herbert Irving Pavilion | 10032 | New York | New York |
| Sidney Kimmel Cancer Center at Thomas Jefferson University | 19107 | Philadelphia | Pennsylvania |
| Sarah Cannon Research Institute - Oncology Partners | 37203 | Nashville | Tennessee |
| MD Anderson | 77030 | Houston | Texas |
| Next Oncology Dallas | 75039 | Irving | Texas |
| NEXT Oncology Virginia | 22031 | Fairfax | Virginia |
| Swedish Cancer Institute | 98104 | Seattle | Washington |
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