Recruiting
Phase 1

ARR-002

Sponsor:

ArriVent BioPharma, Inc.

Code:

NCT07755436

Conditions

Ovarian Cancer

Endometrial Cancer

Platinum-resistant Ovarian Cancer (PROC)

Metastatic Ovarian Cancer

Metastatic Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARR-002

Study Details

Brief 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.

Conditions

Ovarian Cancer

Endometrial Cancer

Platinum-resistant Ovarian Cancer (PROC)

Metastatic Ovarian Cancer

Metastatic Endometrial Cancer

Study ID

NCT07755436

Start date

Jul 23, 2026

Status verified date

Sep, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ARR-002

Interventions

ARR-002

ARR-002 will be administrated as specified in the protocol.

Primary outcome measure

  • Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Baseline to 30 days after the last dose of study treatment ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: Baseline to Day 21 of the first treatment cycle ]

Central Contacts and Locations

Central contacts

Clinical Operations

(888) 622-2827clinicaltrials.gov@arrivent.com

Locations

Sarah Cannon Research Institute at Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology

Recruiting

Irving, Texas, United States, 75039

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

ArriVent BioPharma, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • PROC
  • ARR-002
  • ARR002
  • Advanced Ovarian Cancer
  • Metastatic Ovarian Cancer
  • Endometrial Cancer
  • Platinum-resistant Ovarian Cancer
  • antibody drug conjugates

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ArriVent BioPharma, Inc. on 2026-09-03.