BEHOLD-2: A Study of Mocertatug Rezetecan for Advanced Solid Tumors
This study is for people with advanced solid tumors (cancers that have spread) who haven't responded to standard treatments or can't tolerate them. Researchers are investigating Mocertatug Rezetecan (Mo-Rez) in combination with other anti-cancer therapies like Dostarlimab and Bevacizumab. The main goal is to understand how safe these combinations are and how well your body handles them. They will also look at how effective the treatments are. You might be able to join if you are 18 years or older. The study aims to enroll 305 participants. The current status of the study is unclear.
- Study design
- This interventional study plans to enroll 305 participants. It is a Phase not specified study, meaning it could be an early-stage study.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will monitor for adverse events for up to approximately 22 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06796907
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
Recruiting
PHASE1Ages 18+InterventionalTreatmentGlaxoSmithKline
~305 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Mo-RezDostarlimabBevacizumab
At a glance
Recruiting sites
78 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Percentage of participants with dose limiting toxicities (DLTs)
Measured over Approximately 7 months
+3 more outcomes measured
Conditions
Where it's being run
81 sites across 29 statesSpain10
Brazil6
France5
Argentina4
Belgium4
Germany4
Greece4
Japan4
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 should be provided) with no more than 4 lines of prior systemic therapies. Please note:
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 tissue should be from the most recent procedure (ideally obtained after the last anti-cancer treatment). If an archival tissue is not available a new biopsy should be performed, and the newly obtained tissue provided.
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 progression following locoregional treatment, with the longest diameter of ≥ 10 millimeter (mm) at Baseline (for lymph node lesions, the short axis should be ≥ 15 mm).
Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed.
Participants willing to use adequate contraception.
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.
Exclusion
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 \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.
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 investigator, contraindicates participation in the study.
Has any following cardiological examination abnormality:
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 is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).
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 first dose of study treatment;
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 successfully managed by stenting is permitted.
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 with the participant's safety, obtainment of informed consent, or compliance to the study procedures.
Participants with known history of Human immunodeficiency virus (HIV).
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 half-lives, whichever is shorter of a medicinal product prior to the first dose of study drug; or need to continue these drugs during the study.
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 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.
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.
What this trial measures
- Part A: Percentage of participants with dose limiting toxicities (DLTs)Approximately 7 months
- Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by SeverityUp to approximately 22 months
- Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by FrequencyUp to approximately 22 months
- Part B: Confirmed Objective Response Rate (ORR)Up to approximately 37 months
ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)