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

NCT07755436 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ARR-002-101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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

Endometrial Cancer; Metastatic Ovarian Cancer; Ovarian Cancer; Platinum-resistant Ovarian Cancer (PROC); Metastatic Endometrial Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Treatment-Emergent Adverse Event (TEAE)

  AEs that occur or worsen on or after the first dose of study treatment

  Baseline to 30 days after the last dose of study treatment

• Maximum Tolerated Dose (MTD)

  Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs)

  Baseline to Day 21 of the first treatment cycle

Secondary Outcomes (6)

• Incidence of anti-drug antibody (ADA)

  Baseline to 30 days after the last dose.

• Objective Response Rate (ORR) - Phase Ia

  Baseline to study completion (up to 24 months)

• Duration of Response (DOR)

  Baseline to study completion (up to 24 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 24 months)

• Progression Free Survival (PFS) as assessed by investigator

  Baseline to study completion (up to 24 months)

Study Arms (1)

ARR-002

EXPERIMENTAL

Drug: ARR-002

Interventions

ARR-002 DRUG

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

ARR-002

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ArriVent BioPharma, Inc.: lead

Study Sites (2)

NEXT Oncology

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Central Study Contacts

Clinical Operations

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)