This is a Phase 1 study to assess safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ARR-002 in advanced or metastatic ovarian or endometrial cancer.
This is an open-label, multicenter Phase 1a/1b dose-escalation/expansion, consecutive-cohort, to assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of ARR-002 in adults with locally advanced or metastatic ovarian or endometrial cancer. The study will consist of 2 main parts: * Phase 1a will enroll participants with platinum-resistant ovarian cancer (PROC). This dose-escalation portion will assess the safety and tolerability of ARR-002. * Phase 1b will enroll cohorts of participants by cancer type; platinum-resistant ovarian cancer (PROC) and endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
ARR-002 will be administrated as specified in the protocol.
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology
Irving, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITINGTreatment-Emergent Adverse Event (TEAE)
AEs that occur or worsen on or after the first dose of study treatment
Time frame: Baseline to 30 days after the last dose of study treatment
Maximum Tolerated Dose (MTD)
Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs)
Time frame: Baseline to Day 21 of the first treatment cycle
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 30 days after the last dose.
Objective Response Rate (ORR) - Phase Ia
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Time frame: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Time frame: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion (up to 24 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Time frame: Baseline to study completion (up to 24 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.