Recruiting

Phase 1

AB521A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

Sponsor:

Arcus Biosciences, Inc.

Code:

NCT05536141

Conditions

Clear Cell Renal Cell Carcinoma

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

casdatifan

Cabozantinib

Zimberelimab

Ipilimumab

Study Details

Brief summary:

The purpose of this study is to evaluate the safety and tolerability of:

casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and
casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Conditions

Clear Cell Renal Cell Carcinoma

Solid Tumors

Study ID

NCT05536141

Start date

Oct 26, 2022

Status verified date

Apr, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Must have at least one measurable lesion per RECIST guidance
Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
Disease-specific criteria for dose escalation:

Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
Creatinine clearance ≥ 40 mL/min

Disease-specific criteria for dose-expansion:

Histologically confirmed ccRCC
Creatinine clearance ≥ 40 mL/min

Key Exclusion Criteria:

Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous
History of trauma or major surgery within 28 days prior to the first dose of investigational product
For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.
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.

Study Design

Enrollment

362 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Cohort 1

Participants will receive casdatifan orally once daily

experimental: Dose Escalation Cohort 2

Participants will receive casdatifan orally once daily

experimental: Dose Escalation Cohort 3

Participants will receive casdatifan orally twice daily

experimental: Dose Escalation Cohort 4

Participants will receive casdatifan orally once daily

experimental: Dose Escalation Cohort 5

Participants will receive casdatifan orally once daily

experimental: Dose Expansion Cohort 1