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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05536141
Recruitment Status : Recruiting
First Posted : September 10, 2022
Last Update Posted : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Solid Tumors Drug: AB521 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 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
Actual Study Start Date : October 26, 2022
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation Cohort 1
Participants will receive AB521 orally once daily
 Drug: AB521
Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 2
Participants will receive AB521 orally once daily
 Drug: AB521
Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 3
Participants will receive AB521 orally twice daily
 Drug: AB521
Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 4
Participants will receive AB521 orally
 Drug: AB521
Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 1
Participants will receive AB521 orally
 Drug: AB521
Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 2
Participants will receive AB521 orally
 Drug: AB521
Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 3
Participants will receive AB521 orally
 Drug: AB521
Administered as specified in the treatment arm


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 4 months ]
  2. Number of participants with adverse events (AEs) [ Time Frame: Up to 4 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05536141


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

Locations
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Sponsors and Collaborators
Arcus Biosciences, Inc.
Investigators
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Study Director: Medical Director Arcus Biosciences
More Information
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Responsible Party: Arcus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05536141    
Other Study ID Numbers: ARC-20
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: May 2024
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
URL: https://trials.arcusbio.com/our-transparency-policy

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcus Biosciences, Inc.:
Clear Cell Renal Cell Carcinoma
Solid Tumor Malignancies
Pharmacokinetics
Pharmacodynamics
AB521
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases