drugset / Trial / NCT04165330
Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors
Phase 1/2
Active not recruiting
56 enrolled
Sarcoma Oncology Research Center, LLC
Advenchen Laboratories, LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in combination with Opdivo (nivilumab) for the treatment patients with of metastatic, advanced, or recurrent solid tumors. All participants will receive open-label AL3818 with nivolumab. Part 1 consists of a dose finding phase to determine the recommended phase 2 dosage of AL3818 with nivolumab. Part 2 consists of a dose expansion phase, evaluating the safety and efficacy of the combination in patients cohorts including metastatic, advanced, or recurrent soft tissue sarcomas, non-small cell lung cancer, and small cell lung cancer.
Timeline
- Start
- 2019-10-17
- Primary completion
- 2027-12-31
- Completion
- 2028-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Catequentinib | Small molecule | 6 mg | Oral |
| Subject | Catequentinib | Small molecule | 8 mg | Oral |
| Subject | Catequentinib | Small molecule | 10 mg | Oral |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Other |