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A Clinical Trial to learn about the effects of TLN-372 when given Alone and in Combination with Other Anti-Tumor Agents in people with Advanced KRAS Mutant Solid Cancers
EU CTIS ID: 2025-523086-22-00
What this study is testing
Part 1: To evaluate the safety and tolerability of TLN-372 in patients with locally advanced or metastatic KRAS mutant solid tumors and to estimate the maximum tolerated dose of TLN-372 as a single agent. Part 2: To evaluate the anti-tumor activity of TLN-372 as a single agent in patients with locally advanced or metastatic KRAS mutant solid tumors, to evaluate the anti-tumor activity of TLN-372 in combination with cetuximab and to evaluate the safety of TLN-372 in combination with pembrolizumab.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. At least 18 years of age at the time of signing the informed consent form (ICF).
- 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
You likely can't join if
- 1. Patients must not have active brain metastases
- 2. Patients must not have current or past history of central nervous system (CNS) disease
- 3. Patients must not have major surgery or severe trauma within 4 weeks prior to the first dose of the study drug
- 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
See the full eligibility criteria
- 1. At least 18 years of age at the time of signing the informed consent form (ICF).
- 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
- 1. Patients must not have active brain metastases
- 2. Patients must not have current or past history of central nervous system (CNS) disease
- 3. Patients must not have major surgery or severe trauma within 4 weeks prior to the first dose of the study drug
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.