A Phase 1, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 monotherapy in patients with advanced solid tumors harboring the KRAS p.G12C mutation.
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Status
ATTIVO
Objective of the study
1. To evaluate the safety and tolerability of D3S-001 as monotherapy (Parts 1 and 2) and in combination therapy (Part 3) in adult patients with advanced solid tumors harboring a KRAS p.G12C mutation.
2. To determine the maximum tolerated dose (MTD), if applicable, and the recommended Phase 2 dose (RP2D).
Multiple Conditions
Sponsor: D3 Bio
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-508517-16-00
Medication
D3S-001 (KRAS p.G12C inhibitor)
Pembrolizumab
Cisplatin/Carboplatin
Pemetrexed
Cetuximab
Who is eligible to participate in the study?
Patients who are 18 years of age or older and meet the study’s eligibility criteria may participate in this study.
Patients with KRAS G12C non-small cell lung cancer and PDL1 ≤ 1 who have not received prior treatment.
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