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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeadingtac Pharmaceutical (Shaoxing) Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LT-010391

Treatment groups

198 Participants
are divided into 1 treatment group