NCT05536141 A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
| NCT ID | NCT05536141 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Arcus Biosciences, Inc. |
| Condition | Clear Cell Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 362 participants |
| Start Date | 2022-10-26 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 362 participants in total. It began in 2022-10-26 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Arcus Biosciences
Frequently Asked Questions
Who can join the NCT05536141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clear Cell Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05536141 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05536141 currently recruiting?
Yes, NCT05536141 is actively recruiting participants. Contact the research team at ClinicalTrialInquiry@arcusbio.com for enrollment information.
Where is the NCT05536141 trial being conducted?
This trial is being conducted at Birmingham, United States, San Diego, United States, Santa Monica, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT05536141 clinical trial?
NCT05536141 is sponsored by Arcus Biosciences, Inc.. The principal investigator is Medical Director at Arcus Biosciences. The trial plans to enroll 362 participants.