Clinical trial · Interventional
Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of ARR-002 in Advanced or Metastatic Ovarian or Endometrial Cancer.
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Antitumor Activity of ARR-002 in Adults With Locally Advanced or Metastatic Ovarian or Endometrial Cancer.
NCT07755436CI-TRIAL-00125605recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Platinum-resistant Ovarian Cancer (PROC) | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARR-002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARR-002
- interventionNames
- Drug: ARR-002
Primary outcomes (2)
- measure
- Treatment-Emergent Adverse Event (TEAE)
- timeFrame
- Baseline to 30 days after the last dose of study treatment
- description
- AEs that occur or worsen on or after the first dose of study treatment
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Baseline to Day 21 of the first treatment cycle
- description
- Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.