LT-010391 for advanced solid tumors carrying a KRAS G12D mutation
Tests the safety of LT-010391 tablets in adults with KRAS G12D-mutant advanced tumors.
Key facts
- Who runs it
- Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
- Where
- Hangzhou, ChinaSee the site
- Trial code
- Registry title
- Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors
- Status
- Not yet recruiting
- Phase
- Phase 1
- People taking part
- 198 people, planned
- Started
- Jul 2026
- Expected to end
- Apr 2029
- Type of study
- Interventional
- Treatments tested
- LT-010391
- Record updated
- 3 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors that carry a KRAS G12D gene change. Standard treatment must have failed, not been tolerated, or not exist.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced solid tumors (including lung, colorectal and pancreatic cancer) confirmed by tissue or cell tests
- Earlier treatment
- Standard therapy failed, was not tolerated, or no standard therapy is available
- Biomarker or test result
- KRAS G12D mutation in the tumor
Main reasons for not taking part
- 2 or more primary cancers in the past 5 years (with a few exceptions)
- Primary tumor of the brain or spinal cord (CNS)
- Cancer spread to the membranes around the brain or spinal cord, to the brainstem, or spinal cord compression seen on imaging
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in China
- Zhejiang Cancer HospitalHangzhou, ChinaContact: Zhengbo Song, MDNo longer taking part
About the trial
What the trial wants to find out
This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
The group in the trial
- A single arm study of LT-010391 including dose-escalation and dose-expansion cohortsTreatment being tested
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.
Treatment: LT-010391
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- LT-010391 for advanced solid tumors carrying a KRAS G12D mutationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 June 2026