Trials / Unknown
UnknownNCT05233332
Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)
A Phase Ⅱ, Multicenter Open-label Study to Investigate the Efficacy and Safety of HL-085 Combined With Vemurafenib in Patients With Metastatic Colorectal Cancer (mCRC)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- Sponsor
- Shanghai Kechow Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The study consists of the two parts, phase IIa and phase IIb.
Detailed description
The study consists of the two parts, phase IIa and phase IIb. Phase IIa study is to assess the safety and the antitumor activity in patients with mCRC and to recommend reasonable dosage regimen of HL-085 for phase IIb study. Phase IIb is a pivotal study to evaluate HL-085 plus Vemurafenib in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HL-085 | 12mg BID HL-085 |
| DRUG | Vemurafenib | 720mg BID Vemurafenib |
Timeline
- Start date
- 2022-02-24
- Primary completion
- 2024-01-20
- Completion
- 2024-07-20
- First posted
- 2022-02-10
- Last updated
- 2023-05-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05233332. Inclusion in this directory is not an endorsement.