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

NCT07624214 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: LT010391US001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer (CRC); Advanced Solid Tumors; Non-small Cell Lung Cancer (NSCLC); Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (2)

• Adverse events

  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

• Dose Limiting Toxicities

  Number of participants with Dose Limiting Toxicities (DLTs)

  21 days

Secondary Outcomes (5)

• Pharmacokinetic parameters

  up to 15 weeks

• Overall Response Rate (ORR)

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Disease Control Rate（DCR）

  up to 2 years

• Progression-Free Survival (PFS)

  up to 2 years

Study Arms (1)

A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts

EXPERIMENTAL

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

Interventions

LT-010391 DRUG

LT-010391 tablets, oral, once daily

A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

CONTACT

+86-21-50561622; jxu@leadingtac.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)