BridgeMD
New treatment option for Tumours, Gynecological
Official title A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
ClinicalTrials.gov ID: NCT06796907
What this study is testing
What is Mo-Rez?
Mo-Rez is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tumours, gynecological.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction...
- Participant capable of giving signed informed consent including compliance with the requirements and restrictions listed in the Informed consent form...
- Participants with pathologically confirmed advanced solid tumor specific for study Module (key local diagnostic molecular and/or immunophenotyping...
- Adjuvant +/- neoadjuvant considered one line of therapy
- Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently)
You likely can't join if
- Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell...
- Has had any major surgery within 28 days prior to enrolment.
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- Has known sensitivity to study intervention components, Mo-Rez (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination...
- Has any following cardiological examination abnormality:
- history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, NYHA Class III or IV congestive heart...
See the full eligibility criteria
Who can join
- Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place.
- Participant capable of giving signed informed consent including compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.
- Participants with pathologically confirmed advanced solid tumor specific for study Module (key local diagnostic molecular and/or immunophenotyping testing results/tumor cell phenotype results for confirmed diagnosis...
- Adjuvant +/- neoadjuvant considered one line of therapy
- Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently)
- Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy. If an agent in a regimen is switched to another agent in the same class due to toxicity or intolerance (e.g...
- Requirements for tumor tissue samples: Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by immunohistochemistry (IHC) and other biomarker analysis. The archival tumor...
- Participants have at least one target lesion as assessed per RECIST 1.1. A target lesion is defined as a measurable lesion that has not undergone locoregional treatment such as irradiation or that has unequivocal...
- Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed. of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial...
- Diagnosis of endometrial cancer with confirmed mismatch repair proficient (MMRp) or microsatellites stable (MSS) tumor status by local test.
- Participants who have progressed on or are intolerant to at least 1 line of standard prior systemic therapy (including neoadjuvant or adjuvant as prior line), and who are not candidates for curative external...
- Participants whose advanced ovarian cancer/fallopian tube/peritoneal cancer has relapsed more than 6 months from the last dose of platinum before enrollment, i.e., platinum sensitive.
- Participants who have progressed on or are intolerant to at least 1 line of standard prior lines of chemotherapy and are not candidates for second cytoreductive surgery.
- Participants willing to use adequate contraception. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a Woman of non-childbearing potential (WONCBP) OR
- Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective.
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention
- Has an ECOG performance status of 0 to 1.
- Participants with normal organ and bone marrow function.
What rules you out
- Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g...
- Has had any major surgery within 28 days prior to enrolment.
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- Has known sensitivity to study intervention components, Mo-Rez (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner, or its excipients or other allergy that, in the opinion of the...
- Has any following cardiological examination abnormality:
- history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, NYHA Class III or IV congestive heart failure or clinically significant arrhythmia not controlled by standard...
- Corrected QT Interval (QTcF) \>450 millisecond (msec) or QTcF \>480 msec for participants with bundle branch block
- Has untreated brain or CNS metastases or brain/CNS metastases rapidly progressing requiring urgent medical intervention.
- Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.
- Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy...
- Clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 1 month prior to the first dose of study treatment.
- Serious or poorly controlled hypertension, including history of hypertensive crisis, hypertensive encephalopathy; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the...
- Has any active renal condition (e.g., infection, requirement for dialysis, or any other active significant renal condition or dehydrated condition that could affect the participant's safety). Note: renal obstruction...
- Has any serious and/or unstable medical condition (such as clinical symptoms of intestinal obstruction) or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere...
- Participants with known history of Human immunodeficiency virus (HIV). Exclusion criteria of participants under arm Module 1 (Mo-Rez +Dostarlimab) Endometrial Cancer:
- Has mesenchymal tumor of the uterus (uterine sarcoma).
- Has experienced symptomatic pericarditis of any etiology within 6 months of study treatment or any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any-grade...
- Participants with wound healing complications or incompletely healed wounds.
- Participants with history or evidence of gastrointestinal perforation, tracheoesophageal fistula, or any grade 4 fistula; participants with gastrointestinal fistula, visceral fistula, or abdominal abscess within 6...
- Participants who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
- Participants with congenital bleeding diathesis, acquired coagulopathy, recent pulmonary haemorrhage/ haemoptysis (\> 2.5 mL of red blood or ½ teaspoon) within the last 3 months. Participants receiving treatment for...
- Participant has history of congestive heart failure (CHF) or baseline LVEF \<50% or institutional lower limits of normal.
- Participant with history of nephrotic syndrome or grade 3 proteinuria. Participants has proteinuria as demonstrated by urine dipstick for proteinuria ≥2 (participants discovered to have ≥2 proteinuria on dipstick at...
- Has an Alanine transaminase (ALT) value \>2.5x Upper Limit of Normal (ULN) and for participants with documented liver metastases/tumor infiltration has an ALT value \>5x ULN.
- Has a total bilirubin value \>1.5x ULN.
- Has documented presence of HBsAg and/or HBcAb, or HBsAb (except for presence of HBsAb attributable to previous vaccination) at screening or within 3 months prior to the first dose of study intervention.
- Has a positive HCV antibody test result at screening or within 3 months prior to the first dose of study intervention.
- Has received prior therapy with topoisomerase-1 inhibitors or ADC with topoisomerase-1 inhibitor warhead, or B7H4 targeted therapy.
- Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy, and investigational drug) within 30 days or 5...
- Use of inhibitors of P-gp, breast cancer resistance protein (BCRP) or OATP1B1/1B3 within 7 days prior to the first dose of study drug. P-gp inducers should be discontinued for at least 14 days before the start of the...
- 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...
- Has serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with intravenous antibiotics for ≥2 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Aurora, Colorado, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Buenos Aires, Argentina
- CABA, Argentina
- Viedma, Argentina
- Liverpool, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Barretos, Brazil
- Goiânia, Brazil
- Natal, Brazil
- Porto Alegre, Brazil
- São Paulo, Brazil
- Vitória, Brazil
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Aurora, Colorado, United States; Rochester, New York, United States; Durham, North Carolina, United States; Columbus, Ohio, United States; Buenos Aires, Argentina and 62 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.