Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
- Trial number:
- NCT05462717
- Trial phase:
- 1
- Study type:
- Immunotherapy
- Overall status:
- Recruiting
Study start date
September, 2022
Scientific title
Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
Subject must be ≥18 years of age.Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments. ECOG performance status 0 or 1 Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation Adequate organ function
Study design
Primary purpose:
Treatment, Allocation:
N/A, Intervention model:
Single Group Assignment, Masking:
None (Open Label),
Conditions
Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor
Other study ID numbers
RMC-6291-001