TLN-372 in Advanced KRAS Mutant Solid Tumors

Treeline Biosciences, Inc.

Status and phase

Enrolling

Phase 1

Conditions

KRAS Mutant Solid Tumors

Treatments

Drug: TLN-372 in combination with pembrolizumab

Drug: TLN-372 in combination with cetuximab

Drug: TLN-372

Study type

Interventional

Funder types

Industry

Identifiers

NCT07204340

TLN-372-2501

Details and patient eligibility

About

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

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have measurable disease at study entry.
Patients must have locally advanced or metastatic KRAS mutant solid tumors.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function.

Exclusion criteria

Patients must not have active brain metastases.
Patients must not have current or past history of central nervous system (CNS) involvement.
Patients must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
Patients must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places patients at unacceptable risk of participating in this study.
Patients must not have clinically significant cardiovascular disease.
Pregnant or lactating.
Conditions that could affect drug absorption.