Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)

Sponsor: GlaxoSmithKline

NCT ID: NCT06431594

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mocertatug rezetecan (drug)
How long the study runs
Study runs about 65 months (dates as stated)
About the drug or intervention
Mocertatug rezetecan — drug: Mocertatug rezetecan will be administered
Patient visit burden
Not specified by the sponsor

In plain English

This study, called BEHOLD-1, is testing a drug called mocertatug rezetecan (given by injection) in people with advanced solid tumours. It looks at how safe the drug is, how well people tolerate it, how it moves through the body, and whether it shows any effect on the cancer. The study is run by GlaxoSmithKline.

Who can take part

  • Adults aged 18 or over
  • People with a confirmed advanced solid tumour who have not responded to or cannot tolerate standard treatment
  • People with at least one tumour that can be measured on a scan
  • Willing to provide a tumour tissue sample, ideally from a new biopsy, or a sample stored within the last 2 years
  • Able to carry out day-to-day activities to a reasonable level (performance status score of 0 to 2) with no worsening in the 2 weeks before the first dose
  • Expected to live at least 12 weeks
  • Ovarian, primary peritoneal or fallopian tube cancer group: advanced high-grade serous or endometrioid cancer that has had 1 to 4 previous courses of treatment, is resistant to platinum chemotherapy (the cancer came back or grew within 6 months of finishing platinum treatment), and has previously had bevacizumab unless it was not suitable for them
  • Ovarian cancer group extra points: people whose tumours have a protein called folate receptor-alpha should have had mirvetuximab soravtansine if available locally, and people with BRCA gene changes should have had a PARP (a type of cancer drug) inhibitor if available locally, unless these drugs were not suitable for them
  • Womb (endometrial) cancer group: advanced or cancer that has come back, that has had 1 to 4 previous courses of treatment, and has previously had both platinum chemotherapy and a PD(L)-1 inhibitor (a type of immunotherapy) if available locally, unless not suitable

Who may not be able to

  • Have had any treatment aimed at a protein called B7-H4
  • Have had chemotherapy, other anti-cancer drugs or anti-tumor traditional Chinese medicines within 28 days before the first dose, or need to keep taking them during the study
  • Have had radiotherapy to a specific area within 2 weeks before the first dose, or radiotherapy affecting more than 30% of bone marrow or wide-area radiotherapy within 4 weeks before the first dose
  • Have fluid build-up around the lungs, in the abdomen or around the heart that needs treatment
  • Have had major surgery within 28 days before the first dose
  • Have cancer spread to the brain, unless it is not causing symptoms
  • Have poor bone marrow, liver or kidney function
  • Have certain abnormal heart rhythms or ECG (heart trace) results, including a corrected QT interval over 450 milliseconds, or over 480 milliseconds for people with a specific heart conduction problem
  • Have a heart pumping function (left ventricular ejection fraction) below 50%
  • Have severe or uncontrolled heart problems, poorly controlled high blood pressure, significant bleeding, or serious blood clot events
  • Have inflammation of the lungs (pneumonitis or interstitial lung disease) now or in the past, including drug-related lung inflammation
  • Have had drugs called topoisomerase inhibitors, including versions attached to antibodies (antibody-drug conjugates)
  • Ovarian cancer group: cancer that did not respond at all to first platinum treatment (progressed within 12 weeks), or certain rarer types such as clear-cell, mucinous, germ-cell, low-grade serous or low-grade endometrioid cancer
  • Womb cancer group: sarcomas (a type of tumour) of the womb

What taking part involves

  • • Receiving mocertatug rezetecan by injection
  • • Providing a tumour tissue sample for laboratory testing, including testing for a marker called B7-H4
  • • Having scans to measure the tumour (assessed using standard guidelines called RECIST 1.1)

Time commitment: Not stated — ask the trial team about how long the study lasts, how often visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
675
Started
2024-07-02
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for solid tumors
  • • Phase1 - 675 participants
  • • The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with solid tumors

Where?

  • • Cambridge - GSK Investigational Site
  • • London - GSK Investigational Site
  • • London - GSK Investigational Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Solid TumorsNeoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ received or are intolerant to 1 but no more than 4 lines of prior systemic therapy
  • ✓ had prior bevacizumab , unless there is a documented contraindication or intolerance

What the study is looking for

  • ✓Males or females aged 18 years or older (≥18 years).
  • ✓Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to the usual treatment.
  • ✓PROC cohort
  • ✓Histologically documented, advanced (that has spread and/or unresectable) high-grade serous/endometrioid ovarian, primary...
  • ✓Must have received or are intolerant to 1 but no more than 4 lines of prior treatment that goes through your whole body.

Who cannot take part

  • ✗Have received any B7-H4-treatment that targets specific changes in the cancer
  • ✗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 not causing symptoms;
  • ✗Has inadequate bone marrow health or liver/kidney functions .
See the full criteria
Inclusion 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 1. Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer. 2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy. 3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy. 4. Must have had prior bevacizumab , unless there is a documented contraindication or intolerance. 5. 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. 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. * Endometrial cancer cohort 1. Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer. 2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy. 3. 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 4. 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 newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable. * 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. Exclusion Criteria: * 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 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. * 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 pneumonitis/ILD.Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs) * PROC 1. 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. 2. 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.

Where Is This Study? (3 UK sites)

GSK Investigational Site

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Joo Ern AngPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Rowan MillerPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London W1G 6AD, United Kingdom

Recruiting
Site contact (verified)
Anja WilliamsPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06