Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of ARR-002 in Advanced or Metastatic Ovarian or Endometrial Cancer.

Recruiting now · Phase 1

Conditions studied: Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer (PROC), Metastatic Ovarian Cancer, Metastatic Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT07755436

Run by

ArriVent BioPharma, Inc.

People needed

180

Starts

2026-07-23

Expected to finish

2029-05-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 functions and coagulation function must meet the basic requirements.
• Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

You may not qualify if…

• 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.
• History of uncontrolled diabetes mellitus or diabetic neuropathy within 3 months before the first dose of study treatment.
• Previous drug-induced interstitial lung disease (ILD) or active ILD.
• Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion.
• History of recurrent gastrointestinal (GI) obstruction.
• Patients with more than one cancer.
• Any other diseases, pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding
• Grade ≥ 2 peripheral neuropathy
• History of severe cardiovascular diseases.
• Current use of anticoagulants or thrombolytic agents for therapeutic purposes.
• Known allergic reactions to any component of ARR-002.
• Prior treatment with MUC16- or NaPi2b-targeting agents.
• Ocular conditions such as keratitis or corneal ulceration, monocularity, corneal transplantation, uncontrolled retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder.
• Other situations that are not suitable to participate a clinical trial per investigator's judgement.

Where it is running

• NEXT Oncology — Irving, Texas, United States (enrolling)
• NEXT Oncology — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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