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

Sponsor

Arcus Biosciences, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05536141

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Clear Cell Renal Cell Carcinoma Solid Tumors	Drug: AB521	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: Dose 1 Participants will be orally administered with AB521 "Dose 1" once daily.	Drug: AB521 AB521 will be provided as capsules for oral administration.
Experimental: Cohort 2: Dose 2 Participants will be orally administered with AB521 "Dose 2" once daily.	Drug: AB521 AB521 will be provided as capsules for oral administration.
Experimental: Cohort 3: Dose 3 Participants will be orally administered with AB521 "Dose 3" twice a day.	Drug: AB521 AB521 will be provided as capsules for oral administration.
Experimental: Cohort 4: Dose 4 Participants will be orally administered with AB521 "Dose 4" twice a day.	Drug: AB521 AB521 will be provided as capsules for oral administration.

Outcome Measures

Primary Outcome Measures

Number of participants with incidence of dose limiting toxicities (DLTs) [Up to 4 months]
Number of participants reporting serious adverse events (SAEs) and non-SAEs [Up to 4 months]

Secondary Outcome Measures

Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Up to 4 months]
Plasma concentration of AB521 [Up to 4 months]
Area under the plasma concentration time curve (AUC) of AB521 [Up to 4 months]
Maximum Observed Plasma Concentration (Cmax) of AB521 [Up to 4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.