Trials / Recruiting
RecruitingNCT05886374
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-415S1 in Patients With Advanced Malignant Solid Tumor
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- Sponsor
- Hutchmed · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.
Detailed description
This study is expected to enroll 36-81 patients, including 26-66 patients for dose escalation, additional 10-15 patients will be enrolled at the dose level of determined RP2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HMPL-415S1 | HMPL-415S1 will be supplied as 0.5 mg, 5 mg and 25 mg capsules |
Timeline
- Start date
- 2023-07-06
- Primary completion
- 2025-05-31
- Completion
- 2026-06-30
- First posted
- 2023-06-02
- Last updated
- 2023-07-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05886374. Inclusion in this directory is not an endorsement.