A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)

NCT06796907 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2235592024-517147-31-00
• Study Type: interventional
• Target: 305
• Locations: 23 countries
• Sites: 81

Brief Summary

Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns. Researchers are developing new treatments that combine different medicines for those who do not respond to single medicine. This study is looking at how safe and tolerable Mocertatug Rezetecan (Mo-Rez) is, how the body handles it, and how well it works when used with other cancer medicines. The study will include participants with advanced solid tumors who have either not responded to standard treatments or cannot tolerate them or have no available effective treatment.

Conditions

Tumours, Gynecological

Keywords

Solid Tumors; Mocertatug Rezetecan; Mo-Rez; GSK5733584; BEHOLD-2

Outcome Measures

Primary Outcomes (4)

• Part A: Percentage of participants with dose limiting toxicities (DLTs)

  Approximately 7 months

• Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Severity

  Up to approximately 22 months

• Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Frequency

  Up to approximately 22 months

• Part B: Confirmed Objective Response Rate (ORR)

  ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  Up to approximately 37 months

Secondary Outcomes (16)

• Part A: Confirmed Objective Response Rate (ORR)

  Up to approximately 22 months

• Parts A and B: Duration of response (DoR)

  Up to approximately 37 months

• Parts A and B: Progression-free survival (PFS)

  Up to approximately 37 months

• Part B: Overall Survival (OS)

  Up to approximately 37 months

• Part B: Proportion of participants with CA-125 response

  Up to approximately 37 months

Study Arms (2)

Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer

EXPERIMENTAL

Drug: Mo-Rez; Drug: Dostarlimab

Module 2 (Mo-Rez +/-Bevacizumab) Ovarian Cancer

EXPERIMENTAL

Drug: Mo-Rez; Drug: Bevacizumab

Interventions

Dostarlimab DRUG

Dostarlimab will be administered IV.

Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer

Bevacizumab DRUG

Bevacizumab will be administered IV.

Module 2 (Mo-Rez +/-Bevacizumab) Ovarian Cancer

Mo-Rez DRUG

Mo-Rez will be administered intravenously (IV).

Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer; Module 2 (Mo-Rez +/-Bevacizumab) Ovarian Cancer

Eligibility Criteria

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

You may qualify if:

• Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place.
• Participant capable of giving signed informed consent including compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.
• Participants with pathologically confirmed advanced solid tumor specific for study Module (key local diagnostic molecular and/or immunophenotyping testing results/tumor cell phenotype results for confirmed diagnosis should be provided) with no more than 4 lines of prior systemic therapies. Please note:
• Adjuvant +/- neoadjuvant considered one line of therapy
• Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently)
• Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy. If an agent in a regimen is switched to another agent in the same class due to toxicity or intolerance (e.g. hypersensitivity reaction) this is considered part of the same line (i.e. not counted independently).
• Requirements for tumor tissue samples: Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by immunohistochemistry (IHC) and other biomarker analysis. The archival tumor tissue should be from the most recent procedure (ideally obtained after the last anti-cancer treatment). If an archival tissue is not available a new biopsy should be performed, and the newly obtained tissue provided.
• Participants have at least one target lesion as assessed per RECIST 1.1. A target lesion is defined as a measurable lesion that has not undergone locoregional treatment such as irradiation or that has unequivocal progression following locoregional treatment, with the longest diameter of ≥ 10 millimeter (mm) at Baseline (for lymph node lesions, the short axis should be ≥ 15 mm).
• Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed.
• a. Participants with histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer who have failed in adequate standard treatments, do not have effective standard treatment or are intolerant to standard of care, and who are not candidates for further curative external radiotherapy or brachytherapy.
• Diagnosis of endometrial cancer with confirmed mismatch repair proficient (MMRp) or microsatellites stable (MSS) tumor status by local test.
• Participants who have progressed on or are intolerant to at least 1 line of standard prior systemic therapy (including neoadjuvant or adjuvant as prior line), and who are not candidates for curative external radiotherapy or brachytherapy. Maintenance therapy will be considered part of the preceding line of therapy (i.e, not counted independently).
• a. Participants with histologically or cytologically confirmed advanced epithelial ovarian cancer/fallopian tube/peritoneal cancer (any epithelial histology - mucinous, clear cell, carcinosarcoma, high/low grade serous, endometrioid) who have failed in adequate standard treatments, do not have effective standard treatment or are intolerant to standard of care.
• Participants whose advanced ovarian cancer/fallopian tube/peritoneal cancer has relapsed more than 6 months from the last dose of platinum before enrollment, i.e., platinum sensitive.
• Participants who have progressed on or are intolerant to at least 1 line of standard prior lines of chemotherapy and are not candidates for second cytoreductive surgery.

You may not qualify if:

• Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.
• Has had any major surgery within 28 days prior to enrolment.
• Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
• Has known sensitivity to study intervention components, Mo-Rez (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner, or its excipients or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
• Has any following cardiological examination abnormality:
• history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, NYHA Class III or IV congestive heart failure or clinically significant arrhythmia not controlled by standard of care therapy.
• Corrected QT Interval (QTcF) \>450 millisecond (msec) or QTcF \>480 msec for participants with bundle branch block
• Has untreated brain or CNS metastases or brain/CNS metastases rapidly progressing requiring urgent medical intervention.
• Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.
• Clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 1 month prior to the first dose of study treatment.
• Serious or poorly controlled hypertension, including history of hypertensive crisis, hypertensive encephalopathy; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose of study treatment;
• Has any active renal condition (e.g., infection, requirement for dialysis, or any other active significant renal condition or dehydrated condition that could affect the participant's safety). Note: renal obstruction successfully managed by stenting is permitted.
• Has any serious and/or unstable medical condition (such as clinical symptoms of intestinal obstruction) or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.
• Participants with known history of Human immunodeficiency virus (HIV).
• Has mesenchymal tumor of the uterus (uterine sarcoma).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (81)

GSK Investigational Site

La Jolla, California, 92093, United States

RECRUITING

GSK Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

GSK Investigational Site

Rochester, New York, 55905-0001, United States

RECRUITING

GSK Investigational Site

Durham, North Carolina, 27710, United States

RECRUITING

GSK Investigational Site

Columbus, Ohio, 43210, United States

RECRUITING

GSK Investigational Site

Buenos Aires, C1181ACH, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1280AEB, Argentina

RECRUITING

GSK Investigational Site

CABA, C1187, Argentina

RECRUITING

GSK Investigational Site

Viedma, R8500ACE, Argentina

RECRUITING

GSK Investigational Site

Liverpool, New South Wales, 2170, Australia

RECRUITING

GSK Investigational Site

Wollongong, New South Wales, 2500, Australia

RECRUITING

GSK Investigational Site

Brussels, 1200, Belgium

RECRUITING

GSK Investigational Site

Ghent, 9000, Belgium

RECRUITING

GSK Investigational Site

Leuven, 3000, Belgium

RECRUITING

GSK Investigational Site

Liège, 4000, Belgium

RECRUITING

GSK Investigational Site

Barretos, 14784-400, Brazil

RECRUITING

GSK Investigational Site

Goiânia, 74605-070, Brazil

RECRUITING

GSK Investigational Site

Natal, 59075-740, Brazil

RECRUITING

GSK Investigational Site

Porto Alegre, 90020-090, Brazil

RECRUITING

GSK Investigational Site

São Paulo, 01246-000, Brazil

RECRUITING

GSK Investigational Site

Vitória, 29043-260, Brazil

RECRUITING

GSK Investigational Site

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

GSK Investigational Site

Copenhagen, 2100, Denmark

RECRUITING

GSK Investigational Site

Herlev, Denmark

RECRUITING

GSK Investigational Site

Helsinki, 00029, Finland

RECRUITING

GSK Investigational Site

Tampere, 33520, Finland

RECRUITING

GSK Investigational Site

Lyon, 69373, France

RECRUITING

GSK Investigational Site

Marseille, 13273, France

RECRUITING

GSK Investigational Site

Montpellier, 34298, France

RECRUITING

GSK Investigational Site

Pierre-Bénite, 69495, France

RECRUITING

GSK Investigational Site

Villejuif, 94805, France

RECRUITING

GSK Investigational Site

Cologne, 50931, Germany

RECRUITING

GSK Investigational Site

Leipzig, 04103, Germany

RECRUITING

GSK Investigational Site

Mainz, 55131, Germany

RECRUITING

GSK Investigational Site

München, 81377, Germany

RECRUITING

GSK Investigational Site

Athens, 11528, Greece

RECRUITING

GSK Investigational Site

Athens, 12462, Greece

RECRUITING

GSK Investigational Site

Pylaia Thessaloniki, 570 01, Greece

RECRUITING

GSK Investigational Site

Thessaloniki, 55236, Greece

RECRUITING

GSK Investigational Site

Milan, 20141, Italy

RECRUITING

GSK Investigational Site

Naples, 80131, Italy

RECRUITING

GSK Investigational Site

Roma, 00168, Italy

RECRUITING

GSK Investigational Site

Chiba, 277-8577, Japan

RECRUITING

GSK Investigational Site

Fukuoka, 811-1395, Japan

RECRUITING

GSK Investigational Site

Tokyo, 104-0045, Japan

RECRUITING

GSK Investigational Site

Tokyo, 135-8550, Japan

RECRUITING

GSK Investigational Site

DF, 14080, Mexico

RECRUITING

GSK Investigational Site

San Pedro Garza García, 66260, Mexico

RECRUITING

GSK Investigational Site

Amsterdam, 1066 CX, Netherlands

RECRUITING

GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

RECRUITING

GSK Investigational Site

Rotterdam, 3015 GD, Netherlands

RECRUITING

GSK Investigational Site

Oslo, 0379, Norway

RECRUITING

GSK Investigational Site

Panama City, Panama

RECRUITING

GSK Investigational Site

Panama City, Panama

RECRUITING

GSK Investigational Site

Punta Pacifica Panama City Panama, Panama

RECRUITING

GSK Investigational Site

Bialystok, 15-027, Poland

RECRUITING

GSK Investigational Site

Gliwice, 44-102, Poland

RECRUITING

GSK Investigational Site

Józefów, 05-410, Poland

RECRUITING

GSK Investigational Site

Warsaw, 01-748, Poland

COMPLETED

GSK Investigational Site

Seoul, 05505, South Korea

RECRUITING

GSK Investigational Site

Seoul, 120-752, South Korea

RECRUITING

GSK Investigational Site

Seoul, 135-710, South Korea

RECRUITING

GSK Investigational Site

A Coruña, 15006, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08023, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08035, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08036, Spain

RECRUITING

GSK Investigational Site

Madrid, 28033, Spain

RECRUITING

GSK Investigational Site

Madrid, 28041, Spain

RECRUITING

GSK Investigational Site

Madrid, 28050, Spain

RECRUITING

GSK Investigational Site

Málaga, 29010, Spain

RECRUITING

GSK Investigational Site

Valencia, 46009, Spain

RECRUITING

GSK Investigational Site

Zaragoza, 50009, Spain

RECRUITING

GSK Investigational Site

Stockholm, 17164, Sweden

RECRUITING

GSK Investigational Site

Ankara, 06590, Turkey (Türkiye)

RECRUITING

GSK Investigational Site

Ankara, 6170, Turkey (Türkiye)

RECRUITING

GSK Investigational Site

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

GSK Investigational Site

Glasgow, G12 0YN, United Kingdom

WITHDRAWN

GSK Investigational Site

London, NW1 2BU, United Kingdom

COMPLETED

MeSH Terms

Conditions

Neoplasms

Interventions

dostarlimab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

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

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): June 21, 2027
• Study Completion (Estimated): October 10, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

NO (1); DE (4); CA (4); PA (3); BE (4); AR (4); NL (3); AU (2); GB (2); ES (10); ME (2); US (5); DK (2); SE (1); KR (3); PL (4); FR (5); IT (3); JP (4); BR (6); FI (2); GR (4); TU (3)