CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency
NCT06183736 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2023-12-27
Summary
This is a single-arm, open-label, multicenter, phase II study of CVL237 tablets in the treatment of advanced solid tumors with PTEN deficiency. It is planned to enroll patients with PTEN deficiency advanced solid tumors of different tumor types (PTEN deficiency gastric cancer, prostate cancer, endometrial cancer, colorectal cancer, lung cancer, breast cancer and melanoma etc.) to evaluate the preliminary efficacy, safety and pharmacokinetic profile of CVL237 tablets in patients with PTEN deficiency advanced solid tumors of different tumor types.
Conditions
Interventions
- DRUG
-
CVL237 tablets
CVL237 tablets, 200 mg, taken with food once daily for 28 consecutive days as a treatment cycle.
Sponsors & Collaborators
-
Convalife (Shanghai) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-20
- Primary Completion
- 2025-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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