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A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-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)
RecruitingPhase 1
Sponsor: GlaxoSmithKline
Conditions: Solid Tumors, Neoplasms
Interventions: Mocertatug rezetecan
Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Finland, France
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 overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (65)
- Birmingham, Alabama, United States
- Fountain Valley, California, United States
- Santa Rosa, California, United States
- Lake Mary, Florida, United States
- Orlando, Florida, United States
- Fairway, Kansas, United States
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Mineola, New York, United States
- New York, New York, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- West Valley City, Utah, United States
- Seattle, Washington, United States
- Cipoletti Rio Negro, Argentina
- Ciudad de Buenos Aires, Argentina
- La Plata, Argentina
- Rosario, Argentina
- Blacktown, New South Wales, Australia
- Macquarie University, New South Wales, Australia
- Leuven, Belgium
- Barretos, Brazil
- Goiânia, Brazil
- Rio de Janeiro, Brazil
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
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