Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Advanced Solid Tumors
Investigational drug(s) / intervention(s)
LT-010391
LT-010391: LT-010391 tablets, oral, once daily
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Adverse events — 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
Dose Limiting Toxicities — 21 days Number of participants with Dose Limiting Toxicities (DLTs)
Trial sites (1)
Facility
City
Region
Status
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
More Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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