A Phase 1/2a Study of VS-7375
Phase 1/2
330
about 3.3 years
18+
12 sites in CA, MA, MD +9
What this study is about
Researchers are testing the safety and effectiveness of a treatment called VS-7375 in adults with advanced solid tumors that have a KRAS G12D mutation. The trial will last approximately 1194 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Carboplatin + Pemetrexed + Pembrolizumab
- 2.Take Cetuximab
- 3.Take Gemcitabine
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
carboplatin, cetuximab, gemcitabine, paclitaxel (Taxane chemotherapy; stabilizes microtubules), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer), pemetrexed
injection (Injection), infusion
Primary: Part A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375, Part A: To identify the MTD or MFD, Part C: To characterize the safety, tolerability, and AE profile of VS-7375 in combination regimens.
Secondary: Part A: To characterize the PK of VS-7375 as 2L+ monotherapy administered on a daily oral schedule, Part C: Cohort C3: To evaluate the impact of VS-7375 on nab-paclitaxel PK, Parts B and D: To characterize the safety, tolerability, and AE profile of the recommended VS-7375 regimens from Part A and Part C, Parts B, C, and D: To continue to evaluate the PK of VS-7375 as monotherapy and in combination with other systemic therapies
Oncology