Recruiting NCT07204340
TLN-372 in Advanced KRAS Mutant Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TLN-372, TLN-372 in combination with cetuximab, TLN-372 in combination with pembrolizumab.
- Who it may be relevant to
- Registry conditions: KRAS Mutant Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug TLN-372
Specified dose on specified days - Drug TLN-372 in combination with cetuximab
Specified dose on specified days - Drug TLN-372 in combination with pembrolizumab
Specified dose on specified days
Primary outcome measures
- 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]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- University of Alabama at Birmingham — Birmingham
- Dana-Farber Cancer Institute — Boston
- START Midwest — Grand Rapids
- Washington University Medical Campus — St Louis
- Memorial Sloan Kettering Cancer Center — New York
- Sarah Cannon Research Institute — Nashville
Australia · 2 centers
- Peter MacCallum Cancer Centre — Melbourne
- Linear Clinical Research — Perth
Spain · 2 centers
- Hospital Universitary Vall d'Hebron — Barcelona
- START Madrid_Hospital Universitario HM Sanchinarro_CIOCC — Madrid
Canada · 1 center
- Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT07204340 · TLN-372-2501