Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
Sarcoma Oncology Research Center, LLC
Study ID
NCT04165330
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AL3818 — DRUG
    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.
  • Nivolumab Injection — DRUG
    Nivolumab 240 mg Administered by injection every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.

Study Details

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.

Key Dates

Start date
Oct 17, 2019
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AL3818 plus nivolumab
    Part 1: All participants will be assigned to receive AL3818 capsules orally, once daily at sequential deescalating doses (on treatment Days 1-14 followed by no AL3818 treatment from Days 15-21) in combination with nivolumab injection treatment (on Day 1 and Day 15) for a single 21-day cycle. Participants may continue study treatment at the AL3818 cohort dose at investigator discretion. Part 2: All participants will receive AL3818 capsules orally, once daily at the RP2D determined from Part 1 (on treatment Days 1-14 followed by no AL3818 treatment from Days 15-21) in combination with nivolumab injection treatment (every 2 weeks starting on Cycle 1, Day 1) in 21-day cycles, for up to 24 cycles of total AL3818 therapy.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) [ Time Frame: Cycle 1 (21-days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarcoma Oncology Research CenterSanta MonicaCalifornia90403-

Find similar trials in Santa Monica, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Sarcoma Oncology Research Center· Santa Monica, CA

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