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.
Patients with histologically and cytologically confirmed advanced or metastatic ovarian, primary peritoneal, or fallopian tube cancer, and platinum resistant who have failed or intolerant to standard therapy, or without alternative standard therapy.
Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Tumor specimen available for testing, or agree to biopsy at baseline.
The score of Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Prior treatment with auristatin-derived drugs s (eg, MMAE and monomethyl auristatin F [MMAF]).
Received antitumor therapy within 4 weeks prior to the first dose or 5 half-lives, whichever is shorter.
Infection of active hepatitis B, active hepatitis C, or HIV.
Symptomatic Central nervous system and/or meninges metastasis.
Sequential
ARR-002
DrugARR-002 will be administrated as specified in the protocol.
Treatment-Emergent Adverse Event (TEAE)
AEs that occur or worsen on or after the first dose of study treatment
Maximum Tolerated Dose (MTD)
Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs)
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results.
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.
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.
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
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