AL3818 + Nivolumab for Cancer

Recruiting in Palo Alto (17 mi)

Sant Chawla MD - SARC Clinical Trialist ...

Overseen bySant P Chawla, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sarcoma Oncology Research Center, LLC

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called AL3818 with Opdivo to treat patients with very advanced or returning cancers. AL3818 stops blood supply to tumors, while Opdivo helps the immune system attack cancer cells.

Research Team

Sant P Chawla, MD

Principal Investigator

Sarcoma Oncology Research Center

Eligibility Criteria

This trial is for adults with certain advanced solid tumors, including lung cancer and sarcoma, who've had at least one previous treatment. They must have a good performance status (able to carry out daily activities), proper organ function, controlled blood pressure, no major recent surgeries or untreated brain metastases, and not be on immunosuppressants.

Inclusion Criteria

I am able to care for myself and perform daily activities.

My condition worsened or came back within the last 6 months.

Life expectancy of ≥ 3 months at the time of enrollment.

See 5 more

Exclusion Criteria

I do not have any autoimmune or lung diseases.

My cancer has spread to the lining of my brain and spinal cord.

I have hepatitis C and haven't completed treatment, with a detectable viral load.

See 18 more

Treatment Details

Interventions

AL3818 (Tyrosine Kinase Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study tests AL3818 combined with Nivolumab in patients with advanced solid tumors. It has two parts: first to find the best dose of AL3818 when used with Nivolumab; second to check how safe and effective this combination is in treating different types of cancers like soft tissue sarcoma and lung cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AL3818 plus nivolumabExperimental Treatment2 Interventions

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.