A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label, Phase 1 study to evaluate the safety, pharmacokinetic (PK), preliminary clinical activity, pharmacodynamic (PD), and biomarkers of AB521 as monotherapy for advanced solid tumor malignancies (dose escalation) and clear cell renal cell carcinoma (ccRCC) (dose expansion).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcus Biosciences, Inc.

Criteria

Inclusion Criteria:

• Male or female participants >= 18 years of age (or at least the age that is regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent form (ICF).

• 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 an hypoxia inducible factor (HIF)-2 alpha (α)-targeting therapy.

• Must have at least one measurable lesion per RECIST guidance.

• Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria:

• 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.

• Other, more specific exclusion criteria are defined in the protocol.