TLN-372 in combination with cetuximab: Specified dose on specified days
TLN-372 in combination with pembrolizumab: Specified dose on specified days
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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 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.
5. Patients must not have clinically significant cardiovascular disease.
6. Pregnant or lactating.
7. Conditions that could affect drug absorption.
Primary outcome measure(s)
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372 — Up to 2 years
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation. — Up to 2 years
Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1 — Up to 2 years
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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