Trials / Not Yet Recruiting
Not Yet RecruitingNCT07435038
Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS.
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Betta Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
Detailed description
This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of BPI-572270 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose \[RP2D\] within investigated patient population groups, and to further expand the enrollment of more patients to evaluate the efficacy endpoints (ORR/DCR/DOR/TTR).
Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Advanced Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BPI-572270 | Oral Tablets |
Timeline
- Start date
- 2026-02-12
- Primary completion
- 2028-12-28
- Completion
- 2029-10-28
- First posted
- 2026-02-27
- Last updated
- 2026-03-11
Source: ClinicalTrials.gov record NCT07435038. Inclusion in this directory is not an endorsement.