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NCT Number: NCT07624214

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

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

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Advanced Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Ductal Adenocarcinoma (PDAC) Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location contact

Zhengbo Song, MD

CONTACT

[email protected]

86571-88122146

Zhengbo Song, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LT-010391

Drug

LT-010391 tablets, oral, once daily

Primary outcomes

  1. 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

  2. Dose Limiting Toxicities

    Time frame: 21 days

    Number of participants with Dose Limiting Toxicities (DLTs)

Secondary outcomes

  1. Pharmacokinetic parameters

    Time frame: up to 15 weeks

    Cmax will be recorded from the PK plasma samples collected.

  2. Overall Response Rate (ORR)

    Time frame: up to 2 years

    Assess per RECIST v1.1

  3. Duration of Response (DOR)

    Time frame: up to 2 years

    Assess per RECIST v1.1

  4. Disease Control Rate（DCR）

    Time frame: up to 2 years

    Assess per RECIST v1.1

  5. Progression-Free Survival (PFS)

    Time frame: up to 2 years

    Assess per RECIST v1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

CONTACT

[email protected]

+86-21-50561622

Sponsors and collaborators

Lead sponsor

Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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