OncoMatch/Clinical Trials/NCT06431594
A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Subjects With Advanced Solid Tumors
Is NCT06431594 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies Mocertatug rezetecan for solid tumors.
Treatment: Mocertatug rezetecan — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Ovarian Cancer
Endometrial Cancer
Biomarker criteria
Required: VTCN1 expression (testing required; no eligibility threshold specified)
Tumor tissue ... is required for retrospective detection of B7 homolog 4 (B7-H4) expression by IHC in central laboratory
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — PROC cohort
Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy
Must have received: systemic therapy — Endometrial cancer cohort
Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy
Must have received: platinum-based chemotherapy — PROC cohort
Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy
Must have received: bevacizumab (bevacizumab) — PROC cohort
Must have had prior bevacizumab, unless there is a documented contraindication or intolerance
Must have received: PARP inhibitor — PROC cohort, BRCA mutated tumors
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
Must have received: platinum-based chemotherapy — Endometrial cancer cohort
Must have had prior platinum ... if the regimen is locally available, unless there is a documented contradiction or intolerance
Must have received: anti-PD-1 therapy — Endometrial cancer cohort
Must have had prior ... PD(L)-1 inhibitor ... if the regimen is locally available, unless there is a documented contradiction or intolerance
Cannot have received: B7-H4-targeted therapy
Have received any B7-H4-targeted therapy
Cannot have received: topoisomerase inhibitor
Have received prior therapy with topoisomerase inhibitors
Cannot have received: topoisomerase inhibitor antibody-drug conjugate
Have received prior therapy with ... topoisomerase inhibitor Antibody-drug conjugate (ADCs)
Lab requirements
Blood counts
Has inadequate bone marrow reserve
Kidney function
Has inadequate renal function
Liver function
Has inadequate hepatic function
Cardiac function
Mean Fridericia-corrected QT interval (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%; severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
Has inadequate bone marrow reserve or hepatic/renal functions. Mean Fridericia-corrected QT interval (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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GSK Investigational Site · Orlando, Florida
- GSK Investigational Site · Fairway, Kansas
- GSK Investigational Site · Boston, Massachusetts
- GSK Investigational Site · Detroit, Michigan
- GSK Investigational Site · Grand Rapids, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06431594 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior B7-H4-targeted therapy, topoisomerase inhibitor, topoisomerase inhibitor antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require VTCN1?
Yes, VTCN1 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages