A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
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 in participants with ccRCC in the dose expansion stage
* 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 in participants with ccRCC in the dose expansion stage
Kidney (Renal Cell),
Phase I
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
Not Available
Rini, Brian
International
Vanderbilt University
11-28-2023
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Must have at least one measurable lesion per RECIST guidance
Must have at least one measurable lesion per RECIST guidance
Eastern Cooperative Oncology Group (ECOG) performance status score of 1
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 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:
Disease-specific criteria for dose-expansion:
Histologically confirmed ccRCC
Histologically confirmed ccRCC
Creatinine clearance 40 mL/min
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
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
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
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)-2 inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib
For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2 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
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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Must have at least one measurable lesion per RECIST guidance
Must have at least one measurable lesion per RECIST guidance
Eastern Cooperative Oncology Group (ECOG) performance status score of 1
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 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:
Disease-specific criteria for dose-expansion:
Histologically confirmed ccRCC
Histologically confirmed ccRCC
Creatinine clearance 40 mL/min
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
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
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
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)-2 inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib
For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2 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
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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
