NCT07624214Not yet recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 24 May 2026
- Start date
- Jul 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07624214
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 198
- From Jul 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.