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)
Is NCT06431594 recruiting? Yes, currently enrolling (Sep 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