Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors

May 31, 2026 updated by: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

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

This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multicenter, Phase 1 study of LT-010391, a selective and orally bioavailable KRAS G12D degrader in participants with KRAS G12D mutant advanced solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two parts: Part A- dose escalation and Part B- dose expansion.

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
  • Phone Number: +86-21-50561622
  • Email: jxu@leadingtac.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Zhengbo Song, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts

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.
Drug: LT-010391
LT-010391 tablets, oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicities
Time Frame: 21 days
Number of participants with Dose Limiting Toxicities (DLTs)
21 days
Adverse events
Time Frame: Up to 2 years
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters
Time Frame: up to 15 weeks
Cmax will be recorded from the PK plasma samples collected.
up to 15 weeks
Overall Response Rate (ORR)
Time Frame: up to 2 years
Assess per RECIST v1.1
up to 2 years
Duration of Response (DOR)
Time Frame: up to 2 years
Assess per RECIST v1.1
up to 2 years
Disease Control Rate（DCR）
Time Frame: up to 2 years
Assess per RECIST v1.1
up to 2 years
Progression-Free Survival (PFS)
Time Frame: up to 2 years
Assess per RECIST v1.1
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

May 24, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT010391US001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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