NCT07755436 · ArriVent BioPharma, Inc.
Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of ARR-002 in Advanced or Metastatic Ovarian or Endometrial Cancer.
What this study is about
This is a Phase 1 study to assess safety, tolerability, how the drug moves through the body, immunogenicity, and antitumor activity of ARR-002 in advanced or metastatic ovarian or endometrial cancer.
View original scientific description
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.
Interventions
DRUG
ARR-002
ARR-002 will be administrated as specified in the protocol.
Primary outcome measures
Treatment-Emergent Adverse Event (TEAE)
Time frame: Baseline to 30 days after the last dose of study treatment
AEs that occur or worsen on or after the first dose of study treatment
Maximum Tolerated Dose (MTD)
Time frame: Baseline to Day 21 of the first treatment cycle
Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Irving, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations