Back to Trials
NCT06431594PHASE1Recruiting

A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)

GlaxoSmithKline

Start Date

7/2/2024

Completion Date

12/31/2029

Summary

The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan . The study will also see how the levels of Mo-Rez change over time at different dose amount

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Males or females aged 18 years or older (≥18 years). * Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care. * PROC cohort 1. Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer. 2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy. 3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy. 4. Must have had prior bevacizumab , unless there is a documented contraindication or intolerance. 5. Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtansine if the regimen is locally available, unless there is a documented contraindication or intolerance. Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the regimen is locally available, unless there is a documented contraindication or intolerance. * Endometrial cancer cohort 1. Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer. 2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy. 3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if the regimen is locally available, unless there is a documented contradiction or intolerance 4. All epithelial histologies are permitted including carcinosarcoma. * Participants have at least one target lesion as assessed per the RECIST 1.1 * Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by IHC in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose. * Have a life expectancy of at least 12 weeks. Exclusion Criteria: * Have received any B7-H4-targeted therapy * Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study. * Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment. * Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion * Major surgery within 28 days prior to the first dose of study treatment. * Evidence of brain metastasis unless asymptomatic; * Has inadequate bone marrow reserve or hepatic/renal functions . * Mean Fridericia-corrected QT interval (QTcF) QTcF \>450 msec or QTcF \>480 msec for participants with bundle branch blocK; * Evidence of current clinically significant arrhythmias or ECG abnormalities * Left ventricular ejection fraction (LVEF) \< 50%. * Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events * Has current active pneumonitis/ILD or any history of ILD, any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization/enrollment or any history of drug-induced pneumonitis/ILD.Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs) * PROC 1. Primary platinum refractory disease defined as those who have progressed on or within 12 weeks of last dose of first line platinum therapy not permitted. 2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted. * Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.

Interventions

DRUG

Mocertatug rezetecan

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Solid TumorsNeoplasms

Locations

GSK Investigational Site

Birmingham, Alabama 35294

United States

GSK Investigational Site

Fountain Valley, California 92708

United States

GSK Investigational Site

Santa Rosa, California 95403

United States

GSK Investigational Site

Lake Mary, Florida 32746

United States

GSK Investigational Site

Orlando, Florida 32827

United States

GSK Investigational Site

Fairway, Kansas 66205

United States

GSK Investigational Site

Boston, Massachusetts 02114

United States

GSK Investigational Site

Boston, Massachusetts 02215

United States

GSK Investigational Site

Detroit, Michigan 48201

United States

GSK Investigational Site

Grand Rapids, Michigan 49546

United States

GSK Investigational Site

Minneapolis, Minnesota 55455

United States

GSK Investigational Site

Mineola, New York 11501

United States

GSK Investigational Site

New York, New York 10016

United States

GSK Investigational Site

Portland, Oregon 97213

United States

GSK Investigational Site

Nashville, Tennessee 37203

United States

GSK Investigational Site

Dallas, Texas 75230

United States

GSK Investigational Site

West Valley City, Utah 84119

United States

GSK Investigational Site

Seattle, Washington 98104

United States

GSK Investigational Site

Cipoletti Rio Negro, R8324CVE

Argentina

GSK Investigational Site

Ciudad de Buenos Aires, 1118

Argentina

GSK Investigational Site

La Plata, B1900AVG

Argentina

GSK Investigational Site

Rosario, S2002

Argentina

GSK Investigational Site

Blacktown, New South Wales 2148

Australia

GSK Investigational Site

Macquarie University, New South Wales 2109

Australia

GSK Investigational Site

Leuven, 3000

Belgium

GSK Investigational Site

Barretos, 14784-400

Brazil

GSK Investigational Site

Goiânia, 74605-070

Brazil

GSK Investigational Site

Rio de Janeiro, 20220-410

Brazil

GSK Investigational Site

Ottawa, Ontario K1H 8L6

Canada

GSK Investigational Site

Toronto, Ontario M4N 3M5

Canada

GSK Investigational Site

Toronto, Ontario M5G 2M9

Canada

GSK Investigational Site

Montreal, Quebec H2X 0A9

Canada

GSK Investigational Site

Montreal, Quebec H3T 1E2

Canada

GSK Investigational Site

Helsinki, 00180

Finland

GSK Investigational Site

Helsinki, 00290

Finland

GSK Investigational Site

Tampere, 33520

Finland

GSK Investigational Site

Lyon, 69373

France

GSK Investigational Site

Saint-Herblain, 44805

France

GSK Investigational Site

Villejuif, 94805

France

GSK Investigational Site

Aviano PN, 33081

Italy

GSK Investigational Site

Milan, 20141

Italy

GSK Investigational Site

Milan, 20159

Italy

GSK Investigational Site

Naples, 80131

Italy

GSK Investigational Site

Roma, 00168

Italy

GSK Investigational Site

Saitama, 350-1298

Japan

GSK Investigational Site

Shizuoka, 411-8777

Japan

GSK Investigational Site

Tokyo, 135-8550

Japan

GSK Investigational Site

Amsterdam, 1066 CX

Netherlands

GSK Investigational Site

Gyeonggi-do, 10408

South Korea

GSK Investigational Site

Seoul, 03080

South Korea

GSK Investigational Site

Seoul, 03722

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Córdoba, 14004

Spain

GSK Investigational Site

Girona, 17007

Spain

GSK Investigational Site

Madrid, 28027

Spain

GSK Investigational Site

Madrid, 28034

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Pozuelo de AlarcOn Madr, 28223

Spain

GSK Investigational Site

Stockholm, 17164

Sweden

GSK Investigational Site

Uppsala, SE-751 85

Sweden

GSK Investigational Site

Cambridge, CB2 0QQ

United Kingdom

GSK Investigational Site

London, NW1 2PG

United Kingdom

GSK Investigational Site

London, W1G 6AD

United Kingdom