An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-372 as a Single Agent and in Combination With Other Anti-Tumor Agents, in Patients With Advanced KRAS Mutant Solid Tumors
Treeline Biosciences, Inc.
Summary
The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have measurable disease at study entry. 2. Patients must have locally advanced or metastatic KRAS mutant solid tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Adequate organ function. Exclusion Criteria: 1. Patients must not have active brain metastases. 2. Patients must not have current or past history of central nervous system (CNS) involvement. 3. Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study. 4. Patients must not have any condition, including significant acut…
Interventions
- DrugTLN-372
Specified dose on specified days
- DrugTLN-372 in combination with cetuximab
Specified dose on specified days
- DrugTLN-372 in combination with pembrolizumab
Specified dose on specified days
Locations (11)
- University of Alabama at BirminghamBirmingham, Alabama
- Dana-Farber Cancer InstituteBoston, Massachusetts
- START MidwestGrand Rapids, Michigan
- Washington University Medical CampusSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Sarah Cannon Research InstituteNashville, Tennessee