Trials / Unknown
UnknownNCT06092268
A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-A2009 for injection ； Almonertinib Mesilate Tablets | Phase IB: SHR-A2009 will be administered intravenously，Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB. Phase II: 2 dose cohorts will be selected and it's randomization. |
| DRUG | SHR-A2009 for injection；Adebrelimab Injection | Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB. Phase II: RPD2 will be selected to evaluate preliminary efficacy. |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2023-10-23
- Last updated
- 2023-10-23
Source: ClinicalTrials.gov record NCT06092268. Inclusion in this directory is not an endorsement.