Ovarian CancerPhase 1NCT07755436
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 testing ARR-002 in people with Ovarian Cancer and Endometrial Cancer, run by ArriVent BioPharma, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer (PROC)
- What is being tested?
- ARR-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jul 2026to May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Oncology
Irving, Texas, 75039
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer (PROC), Metastatic Ovarian Cancer, Metastatic Endometrial Cancer
- Being tested
- ARR-002
- Keywords
- PROC, ARR-002, ARR002, Advanced Ovarian Cancer, Metastatic Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer, antibody drug conjugates
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARR-002Drug
ARR-002 will be administrated as specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| ARR-002 | Experimental | Not described Receives: Drug: ARR-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Event (TEAE)
AEs that occur or worsen on or after the first dose of study treatment
Measured: 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)
Measured: Baseline to Day 21 of the first treatment cycle
Secondary outcomes (6)
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results.
Measured: Baseline to 30 days after the last dose.
Objective Response Rate (ORR) - Phase Ia
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.
Measured: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
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.
Measured: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Measured: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 24 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Measured: Baseline to study completion (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start23 Jul 2026
- Primary completionAug 2027 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ArriVent BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755436
- Sponsor's protocol ID
- ARR-002-101
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07755436
- Acronym / sponsor ID
- ARR-002-101
- Conditions
- Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer (PROC), Metastatic Ovarian Cancer, Metastatic Endometrial Cancer
- Keywords
- PROC, ARR-002, ARR002, Advanced Ovarian Cancer, Metastatic Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer, antibody drug conjugates
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- ArriVent BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARR-002 | Experimental | Drug: ARR-002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARR-002ARR-002 will be administrated as specified in the protocol. | Drug | ARR-002 |
Primary outcome
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)
6 secondary outcomes
Incidence of anti-drug antibody (ADA)
Time frame: Baseline to 30 days after the last dose.
Objective Response Rate (ORR) - Phase Ia
Time frame: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
Time frame: Baseline to study completion (up to 24 months)
Overall Survival (OS)
Time frame: Baseline to study completion (up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARR-002 in people with Ovarian Cancer and Endometrial Cancer, run by ArriVent BioPharma, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations ((888) 622-2827, clinicaltrials.gov@arrivent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Event (TEAE) (time frame: Baseline to 30 days after the last dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.