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.