A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors (ARC-20)

• ClinicalTrials.gov Identifier: NCT05536141
• Recruitment Status: Recruiting
• First Posted: September 10, 2022
• Last Update Posted: May 17, 2024
• Sponsor: Arcus Biosciences, Inc.
• Information provided by (Responsible Party): Arcus Biosciences, Inc.

Tracking Information

• First Submitted Date: September 7, 2022
• First Posted Date: September 10, 2022
• Last Update Posted Date: May 17, 2024
• Actual Study Start Date: October 26, 2022
• Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 23, 2023)

• Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 4 months ]
• Number of participants with adverse events (AEs) [ Time Frame: Up to 4 months ]

Original Primary Outcome Measures (submitted: September 7, 2022)

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

Current Secondary Outcome Measures (submitted: September 7, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Clear Cell Renal Cell Carcinoma
• Solid Tumors

Intervention

Drug: AB521

Administered as specified in the treatment arm

Study Arms

• Experimental: Dose Escalation Cohort 1
  Participants will receive AB521 orally once daily
  Intervention: Drug: AB521
• Experimental: Dose Escalation Cohort 2
  Participants will receive AB521 orally once daily
  Intervention: Drug: AB521
• Experimental: Dose Escalation Cohort 3
  Participants will receive AB521 orally twice daily
  Intervention: Drug: AB521
• Experimental: Dose Escalation Cohort 4
  Participants will receive AB521 orally
  Intervention: Drug: AB521
• Experimental: Dose Expansion Cohort 1
  Participants will receive AB521 orally
  Intervention: Drug: AB521
• Experimental: Dose Expansion Cohort 2
  Participants will receive AB521 orally
  Intervention: Drug: AB521
• Experimental: Dose Expansion Cohort 3
  Participants will receive AB521 orally
  Intervention: Drug: AB521

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 7, 2023): 146
• Original Estimated Enrollment (submitted: September 7, 2022): 86
• Estimated Study Completion Date: January 2026
• Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Medical Director; +1-510-462-3330; ClinicalTrials@arcusbio.com

• Listed Location Countries: Korea, Republic of, United States

Administrative Information

• NCT Number: NCT05536141
• Other Study ID Numbers: ARC-20
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Arcus will provide access to individual de-identified participant data and related study documents [e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• URL: https://trials.arcusbio.com/our-transparency-policy

• Current Responsible Party: Arcus Biosciences, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Arcus Biosciences, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Arcus Biosciences

• PRS Account: Arcus Biosciences, Inc.
• Verification Date: May 2024