Trials / Unknown
UnknownNCT05156450
TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Phase Ib/II Clinical Study of TQB3616 Capsules in Combination With Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- West China Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase Ib/II clinical study of TQB3616 capsules in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer, to determine the dose for further clinical studies and to evaluate the safety and efficacy of this combined therapy.
Detailed description
TQB3616 is an inhibitor of Cyclin-dependent kinases 4 and 6 (CDK4/6), which reduces intracellular protein phosphorylation levels, prevents cells from entering synthesis (S) phase from first gap (G1) phase, and inhibits cell proliferation to combat tumors. TQB3616 has superior inhibitory activity to Palbociclib and Abemaciclib against CDK4/6 kinase and may benefit metastatic castration-resistant prostate cancer (mCRPC) patients through a complementary mechanism of action when combined with abiraterone acetate plus prednisone. Therefore, the investigators intend to perform this phase Ib/II clinical study of TQB3616 capsules in combination with abiraterone acetate plus prednisone in patients with mCRPC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone | Treatment with TQB3616 in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer. |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2023-10-01
- Completion
- 2024-01-01
- First posted
- 2021-12-14
- Last updated
- 2021-12-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05156450. Inclusion in this directory is not an endorsement.