Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

Conditions

• Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• zanzalintinib — DRUG
  Specified doses on specified days
• AB521 — DRUG
  Specified doses on specified days
• Nivolumab — BIOLOGICAL
  Specified doses on specified days

Study Details

The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. The main questions it aims to answer are: * The recommended doses (RDs) * The safety and tolerability * The PK and the preliminary efficacy

Key Dates

Start date

Jan 25, 2024

Status verified

Jun 2025

Primary completion

May 12, 2025

Completion

May 12, 2025

Study Design

Enrollment

25 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose-finding Cohort A: Zanzalintinib + AB521
  Participants with solid tumors will receive zanzalintinib + AB521
• Experimental: Dose-finding Cohort B: zanzalintinib + AB521 + nivolumab
  Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab
• Experimental: Expansion Cohort 1: Zanzalintinib + AB521
  Participants with ccRCC will receive zanzalintinib + AB521
• Experimental: Expansion Cohort 2: zanzalintinib + AB521 + nivolumab
  Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab

Primary Outcome Measure

Dose-finding Stage: Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 24 months ]

Locations (14)

Find similar trials in Los Angeles, CA