A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Antitumor Activity of ARR-002 in Adults With Locally Advanced or Metastatic Ovarian or Endometrial Cancer.
ArriVent BioPharma, Inc.
Summary
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.
Description
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 end…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Life expectancy ≥ 12 weeks. * Organ f…
Interventions
- DrugARR-002
ARR-002 will be administrated as specified in the protocol.
Locations (2)
- NEXT OncologyIrving, Texas
- NEXT OncologyFairfax, Virginia