KRAS Mutant Solid TumorsPhase 1NCT07204340
TLN-372 in Advanced KRAS Mutant Solid Tumors
A Phase 1 study testing TLN-372, TLN-372 in combination with cetuximab and TLN-372 in combination with pembrolizumab in people with KRAS Mutant Solid Tumors, run by Treeline Biosciences, Inc. at 11 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS Mutant Solid Tumors
- What is being tested?
- TLN-372, TLN-372 in combination with cetuximab and TLN-372 in combination with pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 29 Sep 2025to 1 Apr 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 4 countries
United States6 sites, 6 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rebecca Arend, rarend@uabmc.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215-5450
Kailene Sullivan, 6176323482, dfcicctiexternalreferral@DFCI.HARVARD.EDU
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Principal Investigator, 616-954-5554, Angela.galindo@startresearch.com
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Brittany Callaway, 615-329-7283, Brittany.Callaway@scri.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021-3402
Jamie Walters, 917-843-7966 ext. waltersj@mskcc
- Recruiting
Washington University Medical Campus
St Louis, Missouri, 63108
Gina Vellequette, 314-253-0616, g.vellequette@wustl.edu
Australia2 sites, 2 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria
Principal Investigator, 61 3 8559 5000, PCCTU.EDD@petermac.org
- Recruiting
Linear Clinical Research
Perth, Western Australia, 6009
Principal Investigator, +61 (08) 6382 5100, actc-management@linear.org.au
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitary Vall d'Hebron
Barcelona, 08035
Principal Investigator
- Recruiting
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
Madrid, 28050
Principal Investigator
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1X6
Principal Investigator
About this study
Official title: An Open-Label, Multicenter, Phase 1 Trial 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
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
- Conditions
- KRAS Mutant Solid Tumors
- Being tested
- TLN-372, TLN-372 in combination with cetuximab, TLN-372 in combination with pembrolizumab
- Keywords
- KRAS mutant solid tumors, KRAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLN-372Drug
Specified dose on specified days
TLN-372 in combination with cetuximabDrug
Specified dose on specified days
TLN-372 in combination with pembrolizumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Single Agent | Experimental | Not described Receives: Drug: TLN-372 |
| Combination Treatment | Experimental | Not described Receives: Drug: TLN-372 in combination with cetuximab; Drug: TLN-372 in combination with pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
Measured: 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.
Measured: Up to 2 years
Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1
Measured: Up to 2 years
Secondary outcomes (8)
Maximum observed plasma concentration (Cmax) of TLN-372
Measured: Up to 2 years
Time to peak drug concentration (Tmax) of TLN-372
Measured: Up to 2 years
Minimum observed plasma concentration (Cmin) of TLN-372
Measured: Up to 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372
Measured: Up to 2 years
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
Measured: Up to 2 years
Frequency of dose interruptions, reductions and dose intensity
Measured: Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Measured: Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start29 Sep 2025
- Primary completion3 Dec 2031 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS Mutant Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Treeline Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204340
- Sponsor's protocol ID
- TLN-372-2501
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1 Trial 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
- ClinicalTrials.gov ID
- NCT07204340
- Acronym / sponsor ID
- TLN-372-2501
- Conditions
- KRAS Mutant Solid Tumors
- Keywords
- KRAS mutant solid tumors, KRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Treeline Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 3 Dec 2031 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Agent | Experimental | Drug: TLN-372 |
| Combination Treatment | Experimental | Drug: TLN-372 in combination with cetuximab, Drug: TLN-372 in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLN-372Specified dose on specified days | Drug | Single Agent |
| TLN-372 in combination with cetuximabSpecified dose on specified days | Drug | Combination Treatment |
| TLN-372 in combination with pembrolizumabSpecified dose on specified days | Drug | Combination Treatment |
Primary outcome
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372
Time frame: 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.
Time frame: Up to 2 years
Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1
Time frame: Up to 2 years
8 secondary outcomes
Maximum observed plasma concentration (Cmax) of TLN-372
Time frame: Up to 2 years
Time to peak drug concentration (Tmax) of TLN-372
Time frame: Up to 2 years
Minimum observed plasma concentration (Cmin) of TLN-372
Time frame: Up to 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372
Time frame: Up to 2 years
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
Time frame: Up to 2 years
Frequency of dose interruptions, reductions and dose intensity
Time frame: Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TLN-372, TLN-372 in combination with cetuximab and TLN-372 in combination with pembrolizumab in people with KRAS Mutant Solid Tumors, run by Treeline Biosciences, Inc. at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Treeline Clinical Operations (857-228-0050, clinicaloperations@treeline.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372 (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.