Clinical trial · Interventional
Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors
A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
NCT07624214CI-TRIAL-00113455not yet recruitingPhase 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)
This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LT-010391 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts
- description
- Part A: Dose Escalation Participants will receive the designated dose. Enrollment into dose escalation may be from any advanced solid tumors with KRAS G12D mutation. Part B: Dose Expansion: Upon completing DLT observation for a dose level, investigators and sponsor may discuss selecting a specific cancer type for expansion at prior dose.
- interventionNames
- Drug: LT-010391
Primary outcomes (2)
- measure
- Adverse events
- timeFrame
- Up to 2 years
- description
- Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
- measure
- Dose Limiting Toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation; * Failed standard therapy, intolerant to standard therapy, or no standard therapy is available; * ECOG Performance Status of 0 or 1; * Adequate organ function Exclusion Criteria: * History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured; * Primary central nervous system (CNS) tumors * leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.