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ACTIVE NOT RECRUITING
NCT04165330
PHASE1/PHASE2

Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors

Sponsor: Sarcoma Oncology Research Center, LLC

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a Evaluation of the Safety and Efficacy of Adding AL3818 (Catequentinib) to Nivolumab in Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2019-10-17

Completion Date

2028-03-31

Last Updated

2025-02-24

Healthy Volunteers

No

Interventions

DRUG

AL3818

AL3818: Part 1 - 12 mg, 10 mg, 8 mg, or 6 mg (by dosing cohort), Part 2 - RP2D (as determined from Part 1). Administered orally once daily on Days 1-14 per 21 day Cycle.

DRUG

Nivolumab Injection

Nivolumab 240 mg Administered by injection every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.

Locations (1)

Sarcoma Oncology Research Center

Santa Monica, California, United States