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High Grade Epithelial Ovarian CancerPhase 1/2RAINFOL-01NCT05579366

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

A Phase 1/2 study testing Rina-S, Carboplatin and Bevacizumab in people with High Grade Epithelial Ovarian Cancer and High Grade Serous Ovarian Cancer, run by Genmab at 66 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rina-S, Carboplatin and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
952 participants
Where
66 sitesin 3 countries
Study dates
7 Dec 2022to Oct 2027
Phase
Phase 1/2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part A and B:
  • Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).
  • Previously received therapies known to confer clinical benefit.
  • Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.
  • Part C, E, and H:
  • Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.
Show all 53Show fewer
  • High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
  • Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
  • Participants must have platinum-resistant ovarian cancer.
  • Participants must have received prior bevacizumab or approved biosimilar.
  • Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.
  • Measurable disease per the RECIST v1.1 at baseline.
  • Part D:
  • Cohort D1:
  • Participants must have platinum-sensitive ovarian cancer.
  • Participants must have received 1 to 3 prior lines of therapy.
  • Cohort D2:
  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
  • Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.
  • Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.
  • Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (>183 days) or more from the last dose of platinum-based therapy.
  • Cohort D3:
  • Endometrial cancer (any subtype excluding sarcoma).
  • Cohort D4:
  • Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).
  • Cohort D5
  • Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).
  • Part F and G:
  • Participants must have histologically or cytologically confirmed EC.
  • Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
  • Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:
  • Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-[L])1 inhibitor.
  • Participants who progress >12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.
  • Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
  • Measurable disease per the RECIST Version 1.1 at baseline.
  • Part I:
  • Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade/borderline ovarian tumors).
  • Participants must have platinum sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.
  • Part J:
  • Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.
  • Measurable disease per the RECIST Version 1.1 at baseline.
  • Part K:
  • Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).
  • Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.
  • Measurable disease per the RECIST Version 1.1 at baseline.
  • Part L:
  • Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy. Participants must have previously received all therapies known to confer clinical benefit (unless ineligible to receive or refused to receive or therapy is unavailable in the region). If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
  • Participants must either have ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element), or
  • NSCLC.
  • Age 18 to 65 years (inclusive).
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Measurable disease per the RECIST version 1.1 at baseline.

Who cannot join

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.
  • Note: Other protocol-defined inclusion/exclusion may apply.

Trial locations and contacts

66 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Genmab Trial Information contact

+4570202728

clinicaltrials@genmab.com

66 sites in 3 countries

United States37 sites, 37 recruiting

  • USOR Texas Oncology

    Abilene, Texas, 79606

    Recruiting

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912

    Recruiting

  • Texas Oncology - Central / South Texas

    Austin, Texas, 78758

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • MD Anderson Cancer Center at Cooper- Two Cooper Plaza

    Camden, New Jersey, 08103

    Recruiting

  • Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

    Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75521

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48085

    Recruiting

  • USOR Alliance Cancer Specialist

    Doylestown, Pennsylvania, 18901

    Recruiting

  • USOR Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

    Recruiting

  • Swedish Cancer Institute

    Everett, Washington, 98104

    Recruiting

  • USOR Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • USOR Florida Cancer Specialists South

    Fort Myers, Florida, 33908

    Recruiting

  • USOR Texas Oncology

    Fort Worth, Texas, 76104

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49503

    Recruiting

  • University of California Los Angeles Medical Center

    Los Angeles, California, 90095

    Recruiting

  • USOR Minnesota Oncology Hematology

    Maplewood, Minnesota, 55109

    Recruiting

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • USOR Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • University of Oklahoma - Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • USOR HonorHealth

    Phoenix, Arizona, 85016

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Compass Oncology - Rose Quarter

    Portland, Oregon, 97227

    Recruiting

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

    Recruiting

  • USOR Maryland Oncology Hematology

    Rockville, Maryland, 20850

    Recruiting

  • University of California, San Diego; Moores Cancer Center

    San Diego, California, 92093

    Recruiting

  • USOR Sansum Clinic

    Santa Barbara, California, 93105

    Recruiting

  • Providence Medical Foundation

    Santa Rosa, California, 95403

    Recruiting

  • USOR Florida Cancer Specialists North

    St. Petersburg, Florida, 33709

    Recruiting

  • USOR Arizona Oncology Associates

    Tucson, Arizona, 85711

    Recruiting

  • Texas Oncology - Northeast TX

    Tyler, Texas, 75702

    Recruiting

  • USOR Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    Recruiting

  • University of Kansas Medical Center (KUMC)

    Westwood, Kansas, 66205

    Recruiting

  • USOR Texas Oncology Gulf Coast

    Woodland, Texas, 77380

    Recruiting

Other trials in United States

China20 sites, 20 recruiting

  • Cancer hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin

    Recruiting

  • Hunan Cancer Hospital - Phase 1

    Changsha, Hunan

    Recruiting

  • Hunan Cancer Hospital - Thoracic Medicine Dept II

    Changsha, Hunan

    Recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Chengdu, Shanghai Municipality

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Recruiting

  • Fujian Cancer Hospital

    Fujian, China

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangdong, China

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Second Affiliated Hospital of Zhengzhou University

    Henan, China

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Hubei, China

    Recruiting

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi

    Recruiting

  • Fudan University Shanghai Cancer Center - Gynecologic Oncology

    Shanghai, Shanghai Municipality

    Recruiting

  • Fudan University Shanghai Cancer Center- Phase 1

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

    Recruiting

  • Sichuan Cancer Hospital

    Shanghai, Sichuan

    Recruiting

  • Second Hospital of Shanxi Medical University

    Shanxi, China

    Recruiting

  • Shanxi Cancer Hospital

    Shanxi, China

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shengyang, China

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, China

    Recruiting

Other trials in China

Japan9 sites, 9 recruiting

  • Hyogo Cancer Center

    Akashi, Hyōgo

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, Fukushima

    Recruiting

  • Saitama Medical University-International Medical Center

    Hidaka, Saitama

    Recruiting

  • Cancer Institute Hospital of JFCR

    Koto, Tokyo

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-chō, Shizuoka

    Recruiting

  • Gunma Prefectural Cancer Center

    Ōta, Gunma

    Recruiting

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido

    Recruiting

  • Keio University Hospital

    Shinjuku-ku, Tokyo

    Recruiting

  • Yamagata University Hospital

    Yamagata, Yamagata

    Recruiting

Other trials in Japan

About this study

Official title: Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Read the detailed description

This is a Phase 1/2 study of Rina-S; also known as GEN1184, formerly known as PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Rina-S in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma.

The study consists of multiple parts:

Part A: monotherapy cohorts

Part B: tumor-specific monotherapy dose-expansion cohorts

Part C: platinum-resistant ovarian cancer (PROC) monotherapy cohort

Part D: combination therapy cohorts

Part E: a monotherapy PROC cohort

Parts F and G: a monotherapy endometrial cancer (EC) cohort

Part H: a monotherapy PROC cohort

Part I: platinum-sensitive ovarian cancer (PSOC) cohort

Part J: a monotherapy PROC cohort

Part K: a monotherapy high-grade ovarian cancer cohort

Part L: a drug-drug interaction substudy

Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Being tested
Rina-S, Carboplatin, Bevacizumab, Pembrolizumab, Erythromycin
Keywords
antibody-drug conjugate, folate receptor alpha, folate receptor, solid tumor, ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, endometrial cancer, non-small cell lung cancer, mesothelioma, breast cancer, triple negative breast cancer, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer, topoisomerase I inhibitor, PROC, epidermal growth factor receptor (EGFR)-mutated NSCLC, pMMR
Medical subject headings
Fallopian Tube Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Mesothelioma, Triple Negative Breast Neoplasms, Uterine Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rina-SDrug

    Also called PRO1184, Rinatabart sesutecan, GEN1184

    Intravenous infusion of Rina-S

  • CarboplatinDrug

    Carboplatin intravenous infusion

  • BevacizumabDrug

    Bevacizumab intravenous infusion

  • PembrolizumabDrug

    Pembrolizumab intravenous infusion

  • ErythromycinDrug

    Erythromycin oral administration

  • ItraconazoleDrug

    Itraconazole oral administration

Study groups in NCT05579366
Study groupRoleWhat they receive
Part A, B, C, E, F, G, H, I, J and KExperimentalRina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.
Receives: Drug: Rina-S
Part D1ExperimentalRina-S in combination with carboplatin
Receives: Drug: Rina-S; Drug: Carboplatin
Part D2 and IExperimentalRina-S in combination with bevacizumab
Receives: Drug: Rina-S; Drug: Bevacizumab
Part D3, D4 and D5ExperimentalRina-S in combination with pembrolizumab
Receives: Drug: Rina-S; Drug: Pembrolizumab
Part LExperimentalRina-S in combination with CYP3A4 inhibitors erythromycin or itraconazole.
Receives: Drug: Rina-S; Drug: Erythromycin; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

    Measured: Through end of treatment, up to approximately 1 year.

  2. Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)

    Measured: At the end of Cycle 1 (each cycle is 21 days)

  3. Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.

    Measured: Through end of treatment, up to approximately 1 year.

  4. Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter

    Measured: Cycles 1 to 3 (each cycle is 21 days)

  5. Part L - Peak Plasma Concentration (Cmax) of Rina-S

    Measurement of maximum plasma concentration after the administration of Rina-S.[

    Measured: Cycles 1 and 2 (each cycle is 21 days)

  6. Part L - Area Under the Plasma Concentration Versus Time Curve (AUC) of Rina-S

    Measurement of AUC after the administration of Rina-S.

    Measured: Cycles 1 and 2 (each cycle is 21 days)

Secondary outcomes (15)

  1. Parts A, B, and D - Best Overall Response (BOR)

    Participants who achieve CR or PR. Best response as assessed by the investigator per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use modified RECIST (mRECIST) v1.1.

    Measured: Up to approximately 1 year.

  2. Parts A, B, D, and E - ORR

    Participants who achieve PR or CR per RECIST v1.1 criteria.

    Measured: Up to approximately 1 year.

  3. Parts A, B, and D - Disease Control Rate (DCR)

    Participants who achieve stable disease, PR or CR per RECIST v1.1 criteria.

    Measured: Up to approximately 1 year.

  4. Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS)

    Time from start of treatment to first documented disease progression or death

    Measured: Through end of treatment, up to approximately 1 year.

  5. Parts C, E, F, G, H, I and J - Overall survival (OS)

    Time from the start of study treatment to the date of death from any cause

    Measured: Up to approximately 2 years.

  6. Parts A, B, C, D, E, F, G, H, I and J - Duration of Objective Response (DOR)

    Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death

    Measured: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months.

  7. Parts A, B, D, and E - Cmax for Rina-S

    Measurement of maximum plasma concentration after the administration of Rina-S.

    Measured: Through end of treatment, up to approximately 1 year.

  8. Parts A, B, D, and E - AUC for Rina-S

    Measurement of AUC after the administration of Rina-S.

    Measured: Through end of treatment, up to approximately 1 year.

  9. Parts A, B, D, and E -Time to Reach Cmax (Tmax) for Rina-S

    Measured: Through end of treatment, up to approximately 1 year

  10. Parts A, B, D, and E - Trough Concentrations (Ctrough) for Rina-S

    Measured: Through end of treatment, up to approximately 1 year

  11. Parts A, B, D, and E- Apparent Terminal Half-life (t1/2) for Rina-S

    Measured: Through end of treatment, up to approximately 1 year

  12. Parts C, D, E, H and J - CA-125 Response Determined Using the Gynecologic Cancer Intergroup (GCIG) Criteria

    Measured: Through end of treatment, up to approximately 1 year

  13. Parts C, E, F, G, H, I, J, K and L - Number of Participants with Type, Incidence, Severity, Seriousness as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and Relatedness of Adverse Events (AEs)

    Measured: Through end of treatment, up to approximately 1 year

  14. Part E - Number of Participants With Antidrug Antibodies (ADA)

    Measured: Through end of treatment, up to approximately 1 year

  15. Part L - Number of Participants with DLT

    Measured: At the end of Cycle 1 (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start7 Dec 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
952 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05579366
Sponsor's protocol ID
GCT1184-01
Other IDs
CTR20230813, jRCT2051250094, PRO1184-001
Acronym
RAINFOL-01
Status last verified
Oct 2026
First submitted
4 Oct 2022
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rina-S, Carboplatin and Bevacizumab in people with High Grade Epithelial Ovarian Cancer and High Grade Serous Ovarian Cancer, run by Genmab at 66 sites in 3 countries.

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 53 inclusion and 3 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, China, Japan. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Genmab Trial Information (+4570202728, clinicaltrials@genmab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] (time frame: Through end of treatment, up to approximately 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05579366.

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 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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