Clinical trial · Interventional
TLN-372 in Advanced KRAS Mutant Solid Tumors
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
NCT07204340CI-TRIAL-00119616recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| KRAS Mutant Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TLN-372 | Drug | — | UNRESOLVED |
| TLN-372 in combination with cetuximab | Drug | — | UNRESOLVED |
| TLN-372 in combination with pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single Agent
- interventionNames
- Drug: TLN-372
- type
- EXPERIMENTAL
- label
- Combination Treatment
- interventionNames
- Drug: TLN-372 in combination with cetuximab
- Drug: TLN-372 in combination with pembrolizumab
Primary outcomes (3)
- measure
- 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
- measure
- Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.