Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors
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- STATUS
- Recruiting
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- End date
- Nov 22, 2022
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- participants needed
- 63
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- sponsor
- Adlai Nortye Biopharma Co., Ltd.
Summary
This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors.
Description
This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors. This study consists of three DLT Observation Periods I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. In all three Observation Periods, a "6 + 3 design" will be utilized for dose finding with dose escalation and de-escalation.
Details
| Condition | Locally Advanced Solid Tumor |
|---|---|
| Treatment | AN0025, Atezolizumab 1200 MG in 20 ML Injection, AN2025 |
| Clinical Study Identifier | NCT04975958 |
| Sponsor | Adlai Nortye Biopharma Co., Ltd. |
| Last Modified on | 22 March 2022 |
Eligibility
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