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This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single arm study of LT-010391 including dose-escalation and dose-expansion cohorts | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT-010391 | Drug | LT-010391 tablets, oral, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs | Up to 2 years |
| Dose Limiting Toxicities | Number of participants with Dose Limiting Toxicities (DLTs) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Cmax will be recorded from the PK plasma samples collected. | up to 15 weeks |
| Overall Response Rate (ORR) | Assess per RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. | Contact | +86-21-50561622 | jxu@leadingtac.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| up to 2 years |
| Duration of Response (DOR) | Assess per RECIST v1.1 | up to 2 years |
| Disease Control Rate(DCR) | Assess per RECIST v1.1 | up to 2 years |
| Progression-Free Survival (PFS) | Assess per RECIST v1.1 | up to 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |