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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
Cancer Categories
Genitourinary (GU)
Karmanos Trial ID
2022-103
NCT ID
NCT05536141
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Elisabeth
Heath, M.D., FACP
Oncology - Medical
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Objective:
Primary Objective:
To characterize the safety and tolerability of AB521 monotherapy in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC)
Secondary Objectives:
To assess the clinical activity of AB521 monotherapy
To characterize the pharmacokinetics (PK) of AB521
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
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
For casdatifan monotherapy cohorts: participants must have received prior treatment in the metastatic setting with an anti-PD-1/PD-L1 therapy and a vascular endothelial growth factor receptor-targeting tyrosine kinase inhibitor (VEGFR-targeting TKI), (either individually or in combination)
For casdatifan + cabozantinib combination therapy: participants must have received prior treatment for locally advanced or metastatic disease with anti-PD-1/PD-L1 therapy in an immediately preceding line of therapy
Must have at least one measurable lesion per RECIST guidance
Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Kidney
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Chemotherapy
Drugs
AB521; Cabozantinib
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