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Clinical Trials in the UK / NCT06431594
Recruiting Phase 1

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

NCT06431594 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 1
Started
2024-07-02
Last updated
2026-06-25

Condition(s) studied

Solid TumorsNeoplasms

Investigational drug(s) / intervention(s)

Mocertatug rezetecan

Mocertatug rezetecan: Mocertatug rezetecan will be administered

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
GSK Investigational Site Birmingham Alabama Recruiting
GSK Investigational Site Fountain Valley California Recruiting
GSK Investigational Site Santa Rosa California Recruiting
GSK Investigational Site Lake Mary Florida Completed
GSK Investigational Site Orlando Florida Recruiting
GSK Investigational Site Fairway Kansas Recruiting
GSK Investigational Site Boston Massachusetts Recruiting
GSK Investigational Site Boston Massachusetts Recruiting
GSK Investigational Site Detroit Michigan Recruiting
GSK Investigational Site Grand Rapids Michigan Recruiting
GSK Investigational Site Minneapolis Minnesota Recruiting
GSK Investigational Site Mineola New York Recruiting
GSK Investigational Site New York New York Recruiting
GSK Investigational Site Portland Oregon Recruiting
GSK Investigational Site Nashville Tennessee Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site West Valley City Utah Recruiting
GSK Investigational Site Seattle Washington Recruiting
GSK Investigational Site Cipoletti Rio Negro Argentina Recruiting
GSK Investigational Site Ciudad de Buenos Aires Argentina Recruiting
GSK Investigational Site La Plata Argentina Recruiting
GSK Investigational Site Rosario Argentina Recruiting
GSK Investigational Site Blacktown New South Wales Recruiting
GSK Investigational Site Macquarie University New South Wales Recruiting
GSK Investigational Site Leuven Belgium Recruiting
GSK Investigational Site Barretos Brazil Recruiting
GSK Investigational Site Goiânia Brazil Recruiting
GSK Investigational Site Rio de Janeiro Brazil Recruiting
GSK Investigational Site Ottawa Ontario Recruiting
GSK Investigational Site Toronto Ontario Recruiting
GSK Investigational Site Toronto Ontario Recruiting
GSK Investigational Site Montreal Quebec Recruiting
GSK Investigational Site Montreal Quebec Recruiting
GSK Investigational Site Helsinki Finland Recruiting
GSK Investigational Site Helsinki Finland Recruiting
GSK Investigational Site Tampere Finland Recruiting
GSK Investigational Site Lyon France Recruiting
GSK Investigational Site Saint-Herblain France Recruiting
GSK Investigational Site Villejuif France Recruiting
GSK Investigational Site Aviano PN Italy Recruiting

+ 25 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06431594 on ClinicalTrials.gov ↗ ← All trials in the UK