240 Participants Needed

TLN-372 for Cancer

Recruiting at 2 trial locations
TC
Overseen ByTreeline Clinical Operations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Treeline Biosciences, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TLN-372 for individuals with advanced solid tumors that have a specific mutation in the KRAS gene. The study aims to determine the safety of TLN-372 and its effectiveness in fighting tumors, either alone or in combination with other cancer treatments. It seeks participants diagnosed with these KRAS mutant tumors that have spread or cannot be surgically removed. Those with this condition, whose daily life is not significantly affected by other severe health problems, might consider joining. As a Phase 1 trial, this research focuses on understanding how TLN-372 works in people, offering the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the TLN-372 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TLN-372 remains in the early stages of human safety testing. Limited information exists on how well people tolerate it. In Phase 1, scientists primarily assess its safety and determine the correct dose. The goal is to understand how the treatment interacts with the body and identify any side effects.

This trial tests TLN-372 both alone and with other cancer treatments. Detailed information about side effects or adverse events from previous studies is currently limited. Phase 1 trials mark the initial step in testing new treatments in humans, helping researchers understand safety before progressing to larger trials.

Prospective participants should recognize that this is very early-stage research. As more individuals participate and results accumulate, safety information will become clearer.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about TLN-372 for cancer treatment because it offers a fresh approach compared to current options like chemotherapy and radiation. Most traditional cancer treatments target rapidly dividing cells, which can also harm healthy cells. TLN-372, however, works differently by specifically targeting cancer cell growth pathways, potentially reducing damage to normal cells. Additionally, its unique mechanism might provide an option for patients who don't respond well to existing therapies, making it a promising development in personalized cancer care.

What evidence suggests that TLN-372 might be an effective treatment for cancer?

Research has shown that TLN-372 targets cancers with specific changes in the KRAS gene. These changes occur in about 25% of adult cancers, making them a significant focus for new treatments. Early results suggest TLN-372 can work alone, as studied in the "Single Agent" arm of this trial, or in combination with other drugs, as explored in the "Combination Treatment" arm, to combat tumor growth in these cases. Although detailed information from human studies remains limited, the drug's method of blocking KRAS-related pathways offers a promising approach to slowing or stopping cancer progression. Scientists remain hopeful that TLN-372 could provide a new option for individuals with advanced cancers that have KRAS mutations.12346

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors that have a specific mutation called KRAS. Participants should be adults who've tried other treatments without success or for whom no suitable alternatives exist.

Inclusion Criteria

My cancer is advanced or has spread, and tests show a KRAS mutation.
My cancer can be measured by tests or scans.
My organs are working well.
See 1 more

Exclusion Criteria

I do not have active brain tumors.
Pregnant or lactating
I have never had cancer spread to my brain or spinal cord.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TLN-372 as a single agent or in combination with other anti-tumor agents

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TLN-372
Trial Overview The study is testing the safety and tumor-fighting ability of a new drug, TLN-372, alone and in combination with cetuximab or pembrolizumab, which are existing cancer therapies.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Single AgentExperimental Treatment1 Intervention
Group II: Combination TreatmentExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Treeline Biosciences, Inc.

Lead Sponsor

Trials
1
Recruited
50+

Citations

TLN-372 in Advanced KRAS Mutant Solid TumorsThe DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.
An Open-Label, Multicenter, Phase 1 Trial to Evaluate the ...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 ...
Ph 1 trials for TLN-121, TLN-254 in lymphoma and TLN- ...Ph 1 trials for TLN-121, TLN-254 in lymphoma and TLN-372 in patients with cancers expressing certain KRAS mutations initiated. September 9, 2025 ...
TLN-372 for CancerThis Phase 1 medical study run by Treeline Biosciences, Inc. is evaluating whether TLN-372 will have tolerable side effects & efficacy for patients with Cancer.
Medicines in the making - Treeline BiosciencesBut cancer drug discovery is a great teacher for working on difficult ... 1. View trial. Solid Tumors. TLN-372. Approximately 1 in 4 adult cancers harbors ...
Treeline reaps $200M series A extension, picks first 3 ...The biotech has also launched clinical testing for a pan-KRAS inhibitor, TLN-372, in cancers with certain KRAS mutations. TLN-121 and TLN-372 ...
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