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

Launched by ARCUS BIOSCIENCES, INC. · Sep 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called casdatifan for people with advanced solid tumors, specifically focusing on clear cell renal cell carcinoma (ccRCC), which is a type of kidney cancer. The trial has two parts: the first part looks at how safe and tolerable casdatifan is when used alone, and the second part tests casdatifan both on its own and in combination with another medication called cabozantinib. The goal is to find out the best doses and to see how well these treatments work for patients who have not had success with other therapies.

To be eligible for this trial, participants need to have a confirmed diagnosis of ccRCC or another solid tumor that hasn’t responded to other treatments. For some groups in the study, patients must have previously received certain types of cancer therapies. Participants should be between the ages of 65 and 74, and they need to have at least one measurable tumor to assess how well the treatment is working. Throughout the trial, participants will be monitored closely for any side effects and how they respond to the treatment. It’s important to note that certain medical conditions or recent treatments may prevent some individuals from joining the study.

Gender

ALL

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
• • 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.