Advanced Solid Tumors, Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
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
Detailed description
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.
Interventions
DRUGLT-010391
LT-010391 tablets, oral, once daily
Sponsors
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters | up to 15 weeks | Cmax will be recorded from the PK plasma samples collected. |
| Overall Response Rate (ORR) | up to 2 years | Assess per RECIST v1.1 |
| Duration of Response (DOR) | up to 2 years | Assess per RECIST v1.1 |
| Disease Control Rate（DCR） | up to 2 years | Assess per RECIST v1.1 |
| Progression-Free Survival (PFS) | up to 2 years | Assess per RECIST v1.1 |
Countries
China
Contacts
CONTACTLeadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Outcome results
None listed