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

Sponsor
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Study ID
NCT07624214
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LT-010391 — DRUG
    LT-010391 tablets, oral, once daily

Study Details

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

Key Dates

First listed
Jun 3, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
198 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Adverse events [ Time Frame: Up to 2 years ]

Central Contacts

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