A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)
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)
Part 1: Number of participants with dose limiting toxicity (DLT) — Up to 21 days
Part 2-Confirmed Objective Response Rate (ORR) assessed by investigator — Up to approximately 28 months ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Trial sites (65)
Facility
City
Region
Status
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.
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.
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