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Tests treatment safety and results for Solid Tumors
Official title A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)
ClinicalTrials.gov ID: NCT06431594
What this study is testing
What is Mocertatug rezetecan?
Mocertatug rezetecan is an investigational medicine, being studied as a potential treatment for solid tumors.
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
- 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
- Phase 1: an early, usually small safety study
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
- 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...
- Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.
You likely can't join 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...
- Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or...
- 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;
See the full eligibility 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
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- 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
+ 34 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 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 and 48 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.