ARR-002 in advanced ovarian or endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter, phase 1a/1b trial that uses a dose-escalation and expansion design to evaluate ARR-002. The study will assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity in adults with locally advanced or metastatic ovarian or endometrial cancer. Phase 1a focuses on escalating doses in platinum-resistant ovarian cancer, while phase 1b expands cohorts by cancer type (PROC and endometrial cancer). Eligibility includes confirmed disease, measurable lesions, ECOG 0-1, adequate organ function, and agreement to contraception for those of reproductive potential. Exclusion includes prior auristatin-derived drug exposure and recent antitumor therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sarah Cannon Research Institute at Florida Cancer Specialists
  Orlando, Florida, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Sarah Cannon Research Institute
  Nashville, Tennessee, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  Irving, Texas, United States Recruiting
• NEXT Oncology
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: clinicaltrials.gov@arrivent.com
• Phone: (888) 622-2827

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• One year vs two years of maintenance immunotherapy for endometrial cancer

  This trial tests whether keeping pembrolizumab or dostarlimab for one year works as well as two years for people with advanced, recurrent, or metastatic endometrial cancer who completed initial chemo and anti-PD1 therapy.

  Recruiting at 6 sites Phase 3 UNC Lineberger Comprehensive Cancer Center · Cary, North Carolina and 5 other locations · NCT07867002

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

• TS-104: a first-in-human, dose-escalation study for advanced solid tumors

  This study tests TS-104, a peptide-drug conjugate, as a single therapy in adults with advanced solid tumors like NSCLC, HNSCC, esophageal, gastric, ovarian, or endometrial cancer to see if it is safe and tolerable and whether it shows any benefit.

  Recruiting at 3 sites Phase 1 TwoStep Therapeutics, Inc. · Maumee, Ohio and 2 other locations · NCT07814248

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.