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

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Key Inclusion Criteria:

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.

Key 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.

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

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