NIZ985 + Spartalizumab for Solid Cancers

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new drug, NIZ985, alone and with two other drugs, in patients with advanced cancers that have worsened after previous treatments. The treatment works by enhancing the immune system's ability to fight cancer.

Eligibility Criteria

This trial is for adults with advanced solid tumors or lymphoma, including melanoma and non-small cell lung cancer (NSCLC), who've had standard treatments fail. They should be in good physical condition, have measurable disease, and be able to follow the study rules. People can't join if they're on high-dose steroids, have other active cancers or serious heart conditions, recently received certain therapies or live vaccines, are pregnant/nursing, or have severe allergies to study drug ingredients.

Participant Groups

The trial is testing NIZ985 alone and combined with Spartalizumab or Tislelizumab to find safe doses and schedules. It aims to understand how these drugs affect the body (pharmacokinetics) and their preliminary effects on tumor growth.

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment3 Interventions

Combination arm. NIZ985 and Spartalizumab combination is administered starting at Cycle 1 Day 1 in dose escalation. NIZ985 and tislelizumab combination is administered starting at Cycle 1 Day 1 in dose expansion.

Group II: Arm 1Experimental Treatment2 Interventions

Single agent arm. NIZ985 is administered as a single agent (subjects may be treated with the NIZ985-Spartalizumab combination after their first disease re-evaluation)