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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Treeline Biosciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Feb 2026 → ongoing

Decision date (initial)

2026-01-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety, Efficacy, Pharmacokinetic, Therapy

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.

Secondary objectives 7

1. Part 1: To characterize the PK of TLN-372 as a single agent
2. Part 1: To evaluate the anti-tumor activity of TLN-372 as a single agent
3. Part 1: To further characterize the safety of TLN-372
4. Part 2: To evaluate the safety and tolerability of TLN-372 as a single agent and in combination with cetuximab
5. Part 2: To evaluate the anti-tumor activity of TLN-372 in combination with pembrolizumab in patients with advanced or metastatic NSCLC
6. Part 2: To further evaluate the anti-tumor activity of TLN-372 as a single agent and in combination with either cetuximab or pembrolizumab
7. Part 2: To characterize the PK of TLN-372 as a single agent and in combination with either cetuximab or pembrolizumab

Conditions and MedDRA coding

Locally advanced or metastatic solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. At least 18 years of age at the time of signing the informed consent form (ICF).
2. 2. Patients must have locally advanced or metastatic KRAS mutant solid tumors
3. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. 4. Adequate organ function

Exclusion criteria 7

1. 1. Patients must not have active brain metastases
2. 2. Patients must not have current or past history of central nervous system (CNS) disease
3. 3. Patients must not have major surgery or severe trauma within 4 weeks prior to the first dose of the study drug
4. 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. 5. Patients must not have clinically significant cardiovascular disease.
6. 6. Pregnant or lactating
7. 7. Conditions that could affect drug absorption

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
2. Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.
3. Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1

Secondary endpoints 5

1. Maximum observed plasma concentration (Cmax), time to peak drug concentration (Tmax), Minimum observed plasma concentration (Cmin), and Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372
2. Anti-tumor activity of TLN-372 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression
3. Frequency of dose interruptions, reductions and dose intensity
4. Clinically significant ECG QT interval from baseline assessed as per NCI CTCAE v5.0
5. Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Treeline Biosciences Inc.

Sponsor organisation

Treeline Biosciences Inc.

Address

500 Arsenal Street

City

Watertown

Postcode

02472-2806

Country

United States

Scientific contact point

Organisation

Treeline Biosciences Inc.

Contact name

Treeline Clinical Operations

Public contact point

Organisation

Treeline Biosciences Inc.

Contact name

Treeline Clinical Operations

Third parties 4

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications