Endometrial Cancer, Metastatic Endometrial Cancer, Metastatic Ovarian Cancer, Ovarian Cancer, Platinum-resistant Ovarian Cancer (PROC)
Conditions
Keywords
PROC, ARR-002, ARR002, Advanced Ovarian Cancer, Metastatic Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer, antibody drug conjugates
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.
Detailed description
This is an open-label, multicenter Phase 1a/1b dose-escalation/expansion, consecutive-cohort, to assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of ARR-002 in adults with locally advanced or metastatic ovarian or endometrial cancer. The study will consist of 2 main parts: * Phase 1a will enroll participants with platinum-resistant ovarian cancer (PROC). This dose-escalation portion will assess the safety and tolerability of ARR-002. * Phase 1b will enroll cohorts of participants by cancer type; platinum-resistant ovarian cancer (PROC) and endometrial cancer.
Interventions
DRUGARR-002
ARR-002 will be administrated as specified in the protocol.
Sponsors
ArriVent BioPharma, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Event (TEAE) | 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) | Baseline to Day 21 of the first treatment cycle | Incidence of dose-limiting toxicities (DLTs) and serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anti-drug antibody (ADA) | Baseline to 30 days after the last dose. | The proportion of patients with positive ADA results. |
| Objective Response Rate (ORR) - Phase Ia | Baseline to study completion (up to 24 months) | ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1. |
| Duration of Response (DOR) | Baseline to study completion (up to 24 months) | The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier. |
| Disease Control Rate (DCR) | Baseline to study completion (up to 24 months) | DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment. |
| Progression Free Survival (PFS) as assessed by investigator | Baseline to study completion (up to 24 months) | PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. |
| Overall Survival (OS) | Baseline to study completion (up to 24 months) | OS is defined as the duration from the start of treatment to death of any cause. |
Countries
United States
Contacts
CONTACTClinical Operations
Outcome results
None listed