Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the safety and tolerability of AB521 when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC).

Official Title

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Keywords

Clear Cell Renal Cell Carcinoma, Solid Tumors, Solid Tumor Malignancies, Pharmacokinetics, Pharmacodynamics, AB521, Carcinoma, Renal Cell Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • Disease-specific criteria for dose escalation:
  • Participants may have any pathologically confirmed solid tumor type where no other treatment options are available.
  • Disease-specific criteria for dose-expansion:
  • Histologically confirmed ccRCC, must have received prior treatment in the metastatic setting (either individually or in combination) with an anti-programmed cell death protein 1 (anti-PD-1) therapy and a tyrosine kinase inhibitor (TKI), and no prior treatment with a hypoxia inducible factor (HIF)-2 alpha (α)-targeting therapy.
  • Must have at least one measurable lesion per RECIST guidance.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.

You CAN'T join if...

  • Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
  • Underlying medical conditions that, in the investigator's judgment, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalizations with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs.
  • History of trauma or major surgery within 28 days prior to the first dose of investigational product.
  • For monotherapy dose expansion: prior treatment with an HIF-2α inhibitor.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UCLA accepting new patients
    Santa Monica California 90404 United States
  • South Texas Accelerated Research Therapeutics, LLC accepting new patients
    San Antonio Texas 78229 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
ID
NCT05536141
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 146 study participants
Last Updated