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

Recruiting now · Phase 1

Conditions studied: Solid Tumors, Neoplasms

In brief

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

Key facts

Study ID: NCT06431594
Run by: GlaxoSmithKline
People needed: 675
Starts: 2024-07-02
Expected to finish: 2029-12-31
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.
Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.
Must have had prior bevacizumab , unless there is a documented contraindication or intolerance.
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
Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer.
Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.
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
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.

You may not qualify if…

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
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.
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.

Where it is running

GSK Investigational Site — Birmingham, Alabama, United States (enrolling)
GSK Investigational Site — Santa Rosa, California, United States (enrolling)
GSK Investigational Site — Fountain Valley, California, United States (enrolling)
GSK Investigational Site — Orlando, Florida, United States (enrolling)
GSK Investigational Site — Fairway, Kansas, United States (enrolling)
GSK Investigational Site — Boston, Massachusetts, United States (enrolling)
GSK Investigational Site — Boston, Massachusetts, United States (enrolling)
GSK Investigational Site — Detroit, Michigan, United States (enrolling)
GSK Investigational Site — Grand Rapids, Michigan, United States (enrolling)
GSK Investigational Site — Minneapolis, Minnesota, United States (enrolling)
GSK Investigational Site — Mineola, New York, United States (enrolling)
GSK Investigational Site — New York, New York, United States (enrolling)
GSK Investigational Site — Portland, Oregon, United States (enrolling)
GSK Investigational Site — Nashville, Tennessee, United States (enrolling)
GSK Investigational Site — Dallas, Texas, United States (enrolling)
GSK Investigational Site — West Valley City, Utah, United States (enrolling)
GSK Investigational Site — Seattle, Washington, United States (enrolling)
GSK Investigational Site — Cipoletti Rio Negro, Argentina (enrolling)
GSK Investigational Site — Ciudad de Buenos Aires, Argentina (enrolling)
GSK Investigational Site — La Plata, Argentina (enrolling)
GSK Investigational Site — Rosario, Argentina (enrolling)
GSK Investigational Site — Blacktown, New South Wales, Australia (enrolling)
GSK Investigational Site — Macquarie University, New South Wales, Australia (enrolling)
GSK Investigational Site — Leuven, Belgium (enrolling)
GSK Investigational Site — Barretos, Brazil (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.