NCT04165330

Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Sarcoma Oncology Research Center, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This phase 1b/2 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 including soft tissue sarcomas (STS), non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC). All participants will receive open-label AL3818 with nivolumab on a scheduled basis. Part 1 (phase 1b) consists of a dose finding phase to determine the safety, tolerability (including recommended phase 2 dosage (RP2D), and PK profile of AL3818 given with nivolumab. Participants will receive oral AL3818 once daily on Days 1-14 and nivolumab injection on Day 1 and 15 of one 21-day cycle. Part 2 (phase 2a) consists of a dose expansion phase, to evaluate the safety and preliminary efficacy of combination treatment using AL3818 at the RP2D determined from Part 1 together with nivolumab injection at standard dosing for patients with metastatic, advanced, or recurrent STS, NSCLC, or SCLC in 21-day cycles. Oral AL3818 will be given on Days 1-14 days and nivolumab will be given every 2 weeks, for up to 24 cycles of total AL3818 therapy.

Conditions

• Solid Tumor, Adult
• Soft Tissue Sarcoma
• Non Small Cell Lung Cancer
• Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-17
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2019-11-15
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study