Study on DS-3939a for Patients with Solid Tumors
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT07739966
This clinical trial is testing the safety and effectiveness of a new drug, DS-3939a, either alone or in combination with other cancer treatments, for patients with solid tumors.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to see if DS-3939a is safe and works well in treating solid tumors. The study will test DS-3939a both by itself and with other cancer drugs. It includes two separate parts: one for patients who have not had certain treatments before, and another for those who have already received some treatments.
Description
The study is divided into two separate substudies:
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Substudy 1: This part will test DS-3939a combined with immunotherapy, with or without chemotherapy drugs like carboplatin or pemetrexed, in patients with advanced non-squamous non-small cell lung cancer (NSQ NSCLC) who have not been treated before.
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Substudy 2: This part will test DS-3939a combined with another drug, DS-1103a, or by itself in patients with advanced NSQ NSCLC who have already received treatment.
Each substudy has two phases:
- Part 1 (Dose Escalation): This phase will determine the safest dose of DS-3939a.
- Part 2 (Dose Expansion): This phase will test the effectiveness of the determined dose. Participants will be randomly assigned to different treatment groups in this phase.
Eligibility Criteria
Inclusion Criteria
- Must sign a consent form before starting any trial-related procedures.
- Must be 18 years or older.
- Must have advanced non-squamous non-small cell lung cancer (NSQ NSCLC) that cannot be removed by surgery.
- Must have a heart function of at least 50% as shown by specific heart tests.
- Must be in good general health, with a performance status score of 0 or 1.
- Must have good organ function.
- Must have measurable cancer according to specific medical criteria.
Additional Criteria for Substudy 1:
- Must not have received prior treatment for advanced NSQ NSCLC.
Additional Criteria for Substudy 2:
- Must have been previously treated with specific therapies for advanced NSQ NSCLC.
- For Part 2, must have received only 1 or 2 prior lines of cancer treatment.
Exclusion Criteria
- Cannot have had previous treatments targeting MUC1 or TA-MUC1.
- Cannot have had treatments with certain topoisomerase 1 inhibitors.
- Cannot have cancer that has spread to the spinal cord or active brain metastases.
- Cannot have multiple types of cancer.
- Cannot have a history of certain lung diseases.
- Cannot have uncontrolled HIV or hepatitis infections.
- Cannot have had certain serious health events like strokes in the past 6 months.
- Cannot be participating in other experimental treatment studies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group (Hog) - Fayetteville | 72703-4005 | Fayetteville | Arkansas |
| UCLA Health | 90095 | Los Angeles | California |
| Moffitt Cancer Center - Magnolia Campus | 33612 | Tampa | Florida |
| Oregon Health & Science University | 97239 | Portland | Oregon |
| Lifespan Cancer Institute - Rhode Island Hospital | 02903 | Providence | Rhode Island |
| The University of Texas Md Anderson Cancer Center | 77030 | Houston | Texas |
| Inova Schar Cancer Institute | 22031 | Fairfax | Virginia |
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