AB521 for Metastatic clear cell renal cell carcinoma | Advanced clear cell renal cell carcinoma

Inclusion criteria

• {"criterion_text":"- Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.\n- A Karnofsky Performance Status (KPS) score ≥ 80%\n- At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.\n- Adequate organ and marrow function ≤ 72 hours prior to randomization.\n- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test."}

Exclusion criteria

• {"criterion_text":"- Received prior treatment with a HIF-2α inhibitor or cabozantinib.\n- Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.\n- Clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.\n- Uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure > 140/90 mm Hg on more than three antihypertensives\n- History of leptomeningeal disease or spinal cord compression."}

Primary endpoints

• {"endpoint_text":"- PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first, as assessed by BICR according to RECIST 1.1.","definition_or_measurement_approach":"PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first, as assessed by blinded independent central review (BICR) according to RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- OS is defined as the time from date of randomization until the date of death from any cause.","definition_or_measurement_approach":"OS is defined as the time from date of randomization until the date of death from any cause."}
• {"endpoint_text":"- ORR is defined as the proportion of patients who have achieved confirmed complete response (CR) or confirmed partial response (PR) to study therapy, as assessed by BICR according to RECIST 1.1.","definition_or_measurement_approach":"ORR = proportion of patients with confirmed CR or PR as assessed by BICR per RECIST 1.1."}
• {"endpoint_text":"- Duration of response is measured from the time of first response (CR or PR) until the date of first documented PD or death, whichever comes first, as assessed by BICR according to RECIST 1.1.","definition_or_measurement_approach":"Duration of response measured from first confirmed CR/PR to first documented PD or death, per BICR RECIST 1.1."}
• {"endpoint_text":"- Disease control rate (DCR) is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 16 weeks from date of randomization, as assessed by BICR according to RECIST 1.1.","definition_or_measurement_approach":"DCR = proportion with confirmed CR, confirmed PR, or stable disease ≥16 weeks from randomization, per BICR RECIST 1.1."}
• {"endpoint_text":"- The incidence and severity of treatment-emergent adverse events and treatment-emergent serious adverse events, and any clinically meaningful trends in safety parameters.","definition_or_measurement_approach":"Incidence and severity of TEAEs and TESAEs per NCI CTCAE v5.0 and summary of clinically meaningful safety parameter trends."}
• {"endpoint_text":"- Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index – Disease Related Symptoms (NFKSI-DRS) Items 1-9 sub-scale score.","definition_or_measurement_approach":"Time to first deterioration in NFKSI-DRS (items 1-9) sub-scale score as reported by patient-reported outcomes."}

Methods

• Dr-to-Patient letter (country-specific) — e.g., documents titled "K2_Recruitment material_Dr to Patient Letter" (channel: letter via treating physician; target audience: patients).
• Dr-to-Dr / Dr-to-GP or Oncologist letter (country-specific) — e.g., "K2_Recruitment material_Dr to Dr Letter", "K2_Recruitment material_Dr to GP or Onco Letter" (channel: letter/email to physicians; target audience: healthcare professionals).
• Flyer / TriFold printed materials (country-specific) — e.g., "K2_Recruitment material_Flyer", "K2_Recruitment material_TriFold" (channel: printed distribution at clinics; target audience: potential patient participants).
• Email to subjects (country-specific) — e.g., "K2_Recruitment material_email to subjects" (channel: email; target audience: prospective participants/patient lists).
• Visit Guide / Patient ID Card / Emergency Card (country-specific) — e.g., "K2_Recruitment material_Visit Guide", "K2_Recruitment material_Patient ID Card" (channel: site-provided materials; target audience: enrolled patients).
• Patient Recruitment Procedure documents for specific countries (e.g., "K1_Patient Recruitment Procedure_NL") describing local recruitment workflow and channels.

France

Earliest CTIS Part Ii Submission Date

24-10-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

33

Number Of Participants

63

Germany

Earliest CTIS Part Ii Submission Date

11-09-2025

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

75

Number Of Participants

56

Italy

Earliest CTIS Part Ii Submission Date

29-09-2025

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

57

Number Of Participants

60

Spain

Earliest CTIS Part Ii Submission Date

23-10-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

32

Number Of Participants

54

Netherlands

Earliest CTIS Part Ii Submission Date

14-11-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

12

Number Of Participants

10

Poland

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

30-11-2025

Processing Time Days

23

Number Of Participants

22

Romania

Earliest CTIS Part Ii Submission Date

22-10-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

35

Number Of Participants

18

Czechia

Earliest CTIS Part Ii Submission Date

27-10-2025

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

29

Number Of Participants

25

Primary sponsor

Full Name

Arcus Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Global Limited

Responsibilities

codes: 8

Name

Syneos Health Inc.

Responsibilities

multiple responsibilities (codes include: 4; and other address-specific codes: 1,12,13,5,8)

Name

Icon Public Limited Company

Responsibilities

codes: 4

Third parties

• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"codes: 3,7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"codes: 10","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc. (Princeton address)","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc. (Morrisville address)","duties_or_roles":"codes: 1,12,13,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"codes: 15 (Long Term Follow Up Support)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}