A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: casdatifan, Cabozantinib, Zimberelimab, Ipilimumab.
- Who it may be relevant to
- Registry conditions: Clear Cell Renal Cell Carcinoma, Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, South Korea, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors
Overview
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.
Interventions
- Drug casdatifan
Administered as specified in the treatment arm - Drug Cabozantinib
Administered as specified in the treatment arm - Drug Zimberelimab
Administered as specified in the treatment arm - Drug Ipilimumab
Administered as specified in the treatment arm
Primary outcome measures
- Number of participants with dose limiting toxicities (DLTs) [Time frame: Up to 4 months]
- Number of participants with adverse events (AEs) [Time frame: Up to 4 months]
Secondary outcome measures (4)
- Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Time frame: Up to 4 months]
- Plasma concentration of casdatifan [Time frame: Up to 4 months]
- Area under the plasma concentration time curve (AUC) of casdatifan [Time frame: Up to 4 months]
- Maximum Observed Plasma Concentration (Cmax) of casdatifan [Time frame: Up to 4 months]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Research Site — Birmingham
- Research Site — San Diego
- Research Site — Santa Monica
- Research Site — Miami
- Research Site — Atlanta
- Research Site — Louisville
- Research Site — New Orleans
- Research Site — Baltimore
- … and 12 more centers
Australia · 3 centers
- Research Site — Camperdown
- Research Site — Melbourne
- Research Site — Sydney
South Korea · 1 center
- Research Site — Seoul
Spain · 1 center
- Research Site — Barcelona
Identifiers
NCT: NCT05536141 · ARC-20 · 2024-519142-70-00