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

Primary Purpose

Clear Cell Renal Cell Carcinoma, Solid Tumors

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AB521

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring Clear Cell Renal Cell Carcinoma, Solid Tumor Malignancies, Pharmacokinetics, Pharmacodynamics, AB521

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University of Louisville Brown Cancer CenterRecruiting
Mid-Florida Hematology & Oncology Centers, PARecruiting
Dana-Farber Cancer InstituteRecruiting
Barbara Ann Karmanos Cancer CenterRecruiting
Nebraska Cancer Specialists - Oncology Hematology West PCRecruiting
Sarah CannonRecruiting
Seoul National University Bundang HospitalRecruiting
Samsung Medical CenterRecruiting
Asan Medical CenterRecruiting
Severance Hospital Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Dose Escalation Cohort 1

Dose Escalation Cohort 2

Dose Escalation Cohort 3

Dose Escalation Cohort 4

Dose Expansion

Arm Description

Participants will receive AB521 orally once daily

Participants will receive AB521 orally twice daily

Participants will receive AB521 orally

Outcomes

Primary Outcome Measures

Number of participants with dose limiting toxicities (DLTs)

Number of participants with adverse events (AEs)

Secondary Outcome Measures

Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Plasma concentration of AB521

Area under the plasma concentration time curve (AUC) of AB521

Maximum Observed Plasma Concentration (Cmax) of AB521

Full Information

NCT ID

NCT05536141

First Posted

September 7, 2022

Last Updated

October 3, 2023

Sponsor

Arcus Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05536141

Brief Title

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

Acronym

ARC-20

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 26, 2022 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arcus Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clear Cell Renal Cell Carcinoma, Solid Tumors

Keywords

Clear Cell Renal Cell Carcinoma, Solid Tumor Malignancies, Pharmacokinetics, Pharmacodynamics, AB521

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation Cohort 1

Arm Type

Experimental

Arm Description

Participants will receive AB521 orally once daily

Arm Title

Dose Escalation Cohort 2

Arm Type

Experimental

Arm Description

Participants will receive AB521 orally once daily

Arm Title

Dose Escalation Cohort 3

Arm Type

Experimental

Arm Description

Participants will receive AB521 orally twice daily

Arm Title

Dose Escalation Cohort 4

Arm Type

Experimental

Arm Description

Participants will receive AB521 orally

Arm Title

Dose Expansion

Arm Type

Experimental

Arm Description

Participants will receive AB521 orally

Intervention Type

Drug

Intervention Name(s)

AB521

Intervention Description

Administered as specified in the treatment arm

Primary Outcome Measure Information:

Title

Number of participants with dose limiting toxicities (DLTs)

Time Frame

Up to 4 months

Title

Number of participants with adverse events (AEs)

Time Frame

Up to 4 months

Secondary Outcome Measure Information:

Title

Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time Frame

Up to 4 months

Title

Plasma concentration of AB521

Time Frame

Up to 4 months

Title

Area under the plasma concentration time curve (AUC) of AB521

Time Frame

Up to 4 months

Title

Maximum Observed Plasma Concentration (Cmax) of AB521

Time Frame

Up to 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Medical Director

Phone

+1-510-462-3330

ClinicalTrials@arcusbio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Arcus Biosciences

Official's Role

Study Director

Facility Information:

Facility Name

University of Louisville Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Name

Mid-Florida Hematology & Oncology Centers, PA

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Individual Site Status

Recruiting

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Name

Barbara Ann Karmanos Cancer Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Recruiting

Facility Name

Nebraska Cancer Specialists - Oncology Hematology West PC

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Individual Site Status

Recruiting

Facility Name

Sarah Cannon

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Individual Site Status

Recruiting

Facility Name

Seoul National University Bundang Hospital

City

Seoul

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

6351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Severance Hospital Cancer Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://trials.arcusbio.com/our-transparency-policy

Learn more about this trial

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

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