TLN-372 in Advanced KRAS Mutant Solid Tumors

NCT07204340
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
270
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Lead sponsor
Treeline Biosciences, Inc.
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Start date
2025-09-29
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Number of sites
11
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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
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Short title
TLN-372 in Advanced KRAS Mutant Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2032-04-01
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First posted
2025-10-02
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Registry last updated
2026-07-28
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Primary completion date
2031-12-03
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Start date
2025-09-29
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Participants
270
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Participant count basis
Estimated
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Planned participants
270
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Protocol amendments
1
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Number of sites
11
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Treeline Biosciences, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07204340
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ClinicalTrials.gov ID
NCT07204340
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372

    Timeframe: Up to 2 years

  2. Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.

    Timeframe: Up to 2 years

  3. Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1

    Timeframe: Up to 2 years

  1. Maximum observed plasma concentration (Cmax) of TLN-372

    Timeframe: Up to 2 years

  2. Time to peak drug concentration (Tmax) of TLN-372

    Timeframe: Up to 2 years

  3. Minimum observed plasma concentration (Cmin) of TLN-372

    Timeframe: Up to 2 years

  4. Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372

    Timeframe: Up to 2 years

  5. 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

    Timeframe: Up to 2 years

  6. Frequency of dose interruptions, reductions and dose intensity

    Timeframe: Up to 2 years

  7. Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0

    Timeframe: Up to 2 years

  8. Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0

    Timeframe: Up to 2 years

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
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  • University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • START MidwestGrand Rapids, United StatesRecruiting
  • Washington University Medical CampusSt Louis, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Sarah Cannon Research InstituteNashville, United StatesRecruiting
  • Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
  • Linear Clinical ResearchPerth, AustraliaRecruiting
  • Princess Margaret Cancer CentreToronto, CanadaRecruiting
  • Hospital Universitary Vall d'HebronBarcelona, SpainRecruiting
  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCCMadrid, SpainRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)