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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (3 UK sites)
GSK Investigational Site
Cambridge CB2 0QQ, United Kingdom
GSK Investigational Site
London NW1 2PG, United Kingdom
GSK Investigational Site
London W1G 6AD, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
