A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors
A Phase 1 Study of AB521 in Renal Cell Carcinoma and Other Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of AB521 when taken
alone in participants with advanced solid tumor malignancies and clear cell renal cell
carcinoma (ccRCC).
alone in participants with advanced solid tumor malignancies and clear cell renal cell
carcinoma (ccRCC).
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
BOTH
NO
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, must have received prior treatment in the metastatic setting (either individually or in combination) with an anti-programmed cell death protein 1 (anti-PD-1) therapy and a tyrosine kinase inhibitor (TKI), and no prior treatment with a hypoxia inducible factor (HIF)-2 alpha ()-targeting 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.
Underlying medical conditions that, in the investigator's judgment, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalizations with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs.
History of trauma or major surgery within 28 days prior to the first dose of investigational product.
For monotherapy dose expansion: prior treatment with an HIF-2 inhibitor.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
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, must have received prior treatment in the metastatic setting (either individually or in combination) with an anti-programmed cell death protein 1 (anti-PD-1) therapy and a tyrosine kinase inhibitor (TKI), and no prior treatment with a hypoxia inducible factor (HIF)-2 alpha ()-targeting 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.
Underlying medical conditions that, in the investigator's judgment, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalizations with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs.
History of trauma or major surgery within 28 days prior to the first dose of investigational product.
For monotherapy dose expansion: prior treatment with an HIF-2 inhibitor.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
