Solid TumorsPhase 1NCT06431594
A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)
A Phase 1 study testing Mocertatug rezetecan in people with Solid Tumors and Neoplasms, run by GlaxoSmithKline at 65 sites in 15 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Neoplasms
- What is being tested?
- Mocertatug rezetecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 65 sitesin 15 countries
- Study dates
- 2 Jul 2024to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
- Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.
- Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.
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- Must have had prior bevacizumab , unless there is a documented contraindication or intolerance.
- 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
- Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer.
- Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.
- 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
- 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.
Who cannot join
- 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;
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- 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
- 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.
- 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.
Trial locations and contacts
65 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
65 sites in 15 countries
United States18 sites, 17 recruiting
- Recruiting
GSK Investigational Site
Birmingham, Alabama, 35294
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Boston, Massachusetts, 02114
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Boston, Massachusetts, 02215
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Dallas, Texas, 75230
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Detroit, Michigan, 48201
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fairway, Kansas, 66205
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fountain Valley, California, 92708
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Grand Rapids, Michigan, 49546
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Lake Mary, Florida, 32746
- Recruiting
GSK Investigational Site
Mineola, New York, 11501
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Minneapolis, Minnesota, 55455
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nashville, Tennessee, 37203
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
New York, New York, 10016
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Orlando, Florida, 32827
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Portland, Oregon, 97213
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Santa Rosa, California, 95403
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seattle, Washington, 98104
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
West Valley City, Utah, 84119
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Spain8 sites, 8 recruiting
- Recruiting
GSK Investigational Site
Barcelona, 08035
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Córdoba, 14004
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Girona, 17007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28027
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28034
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28040
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28046
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Montreal, Quebec, H2X 0A9
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Montreal, Quebec, H3T 1E2
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toronto, Ontario, M4N 3M5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toronto, Ontario, M5G 2M9
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Italy5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Aviano PN, 33081
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Milan, 20141
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Milan, 20159
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Naples, 80131
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Roma, 00168
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Argentina4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Cipoletti Rio Negro, R8324CVE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ciudad de Buenos Aires, 1118
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
La Plata, B1900AVG
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rosario, S2002
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Korea4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Gyeonggi-do, 10408
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 03080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 03722
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 06351
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Brazil3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Barretos, 14784-400
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Goiânia, 74605-070
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rio de Janeiro, 20220-410
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Finland3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Helsinki, 00180
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Helsinki, 00290
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tampere, 33520
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
France3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Lyon, 69373
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Saint-Herblain, 44805
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Villejuif, 94805
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Saitama, 350-1298
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Shizuoka, 411-8777
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 135-8550
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Cambridge, CB2 0QQ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
London, NW1 2PG
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
London, W1G 6AD
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Blacktown, New South Wales, 2148
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Macquarie University, New South Wales, 2109
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Sweden2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Stockholm, 17164
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Uppsala, SE-751 85
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Belgium1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Leuven, 3000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Netherlands1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Amsterdam, 1066 CX
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
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
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
- Conditions
- Solid Tumors, Neoplasms
- Being tested
- Mocertatug rezetecan
- Keywords
- Solid Tumors, Mocertatug rezetecan, Mo-Rez, GSK5733584, BEHOLD-1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mocertatug rezetecanDrug
Mocertatug rezetecan will be administered
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants with advanced solid tumors who are refractory or intolerant to established standard therapies Receives: Drug: Mocertatug rezetecan |
| Part 2: Dose Expansion | Experimental | Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC) Receives: Drug: Mocertatug rezetecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of participants with dose limiting toxicity (DLT)
Measured: Up to 21 days
Part 2-Confirmed Objective Response Rate (ORR) assessed by investigator
ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: Up to approximately 28 months
Secondary outcomes (42)
Part 1 and 2: Maximum observed concentration (Cmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin
Measured: Up to approximately 31 months
Part 1 and 2: Time to reach Cmax (Tmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin
Measured: Up to approximately 31 months
Part 1 and 2: Area under the concentration-time curve (AUC) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin
Measured: Up to approximately 31 months
Part 1- Confirmed Objective Response Rate assessed by investigator
ORR is defined as the proportion of participants with at least one confirmed CR or PR as defined by RECIST 1.1
Measured: Up to approximately 31 months
Part 1 and 2: Duration of response (DoR) assessed by investigator
DoR is defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
Measured: Up to approximately 31 months
Part 1 and 2: Progression-free survival (PFS) assessed by investigator
PFS is defined as the time interval between randomization (or from the first dose of the intervention) and the first documented disease progression or death due to any cause (whichever occurs first).
Measured: Up to approximately 31 months
Part 1 and 2: Number of participants with treatment-emergent Anti-drug antibodies (ADA) / Neutralizing antibody (NAb)
Measured: Up to approximately 31 months
Part 1 and 2: Titers of ADA to Mocertatug Rezetecan
Measured: Up to approximately 31 months
Part 1 and 2: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Measured: Up to approximately 31 months
Part 1 and 2: Change from baseline in body temperature (degree Celsius)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in respiratory rate (breaths per minute)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in pulse rate (beats per minute)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in weight [kilogram (kg)]
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Estimated glomerular filtration rate (eGFR) (milliliter per minute)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Prothrombin Time (PT), Partial thromboplastin time (PTT) or Activated Partial Thromboplastin Time (aPTT) (seconds)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
Leukocyte esterase measured as negative or positive
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in CA-125 tumor marker among ovarian cancer participants [units per milliliter (U/mL)]
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Thyroid stimulating hormone (TSH) [microunits per milliliter (µU/mL)]
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in free thyroxine (T4) [nanograms per deciliter (ng/dL)]
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]
Measured: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
ECOG PS is used for measuring how the disease impacts a patient's daily living abilities. The grades for the scale range from 0 (fully active) to 5 (dead), with increasing severity.
Measured: Baseline (Day -1) and up to approximately 31 months
Part 2: Overall Survival (OS)
OS is defined as the time interval between the date of randomization (or from the first dose of the investigational product) and the date of death due to any cause
Measured: Up to approximately 31 months
Part 2-Confirmed Objective Response Rate (ORR) assessed by BICR
ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: Up to approximately 31 months
Part 2: Duration of response (DoR) assessed by BICR
DoR is defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
Measured: Up to approximately 31 months
Part 2: Progression-free survival (PFS) assessed by BICR
PFS is defined as the time interval between randomization (or from the first dose of the intervention) and the first documented disease progression or death due to any cause (whichever occurs first).
Measured: Up to approximately 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start2 Jul 2024
- Primary completion22 Sep 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431594
- Sponsor's protocol ID
- 222730
- Other IDs
- 2024-513860-25
- Status last verified
- Jun 2026
- First submitted
- 21 May 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Publications
Lheureux S, Provencher D, Baka S, Kowalyszyn R, Schutte T, Urun Y, Zeng X, Oaknin A, Lorusso D, Ray-Coquard I, Moreno V, Jalkanen K, Liu Burstrom L, van Dongen MGJ, Boni V, Lee JY, Bedard PL, Malinowska IA, Kaisermann M, McKean W. BEHOLD-1 and -2: phase 1/2 randomized studies evaluating the B7 homolog 4 protein-targeted antibody-drug conjugate mocertatug rezetecan in patients with solid tumors, including endometrial and ovarian cancers. Int J Gynecol Cancer. 2026 Sep 7:105607. doi: 10.1016/j.ijgc.2026.105607. Online ahead of print.
PubMed 42850140
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06431594
- Acronym / sponsor ID
- 222730
- Conditions
- Solid Tumors, Neoplasms
- Keywords
- Solid Tumors, Mocertatug rezetecan, Mo-Rez, GSK5733584, BEHOLD-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: Mocertatug rezetecanParticipants with advanced solid tumors who are refractory or intolerant to established standard therapies |
| Part 2: Dose Expansion | Experimental | Drug: Mocertatug rezetecanParticipants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mocertatug rezetecanMocertatug rezetecan will be administered | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
Part 1: Number of participants with dose limiting toxicity (DLT)
Time frame: Up to 21 days
Part 2-Confirmed Objective Response Rate (ORR) assessed by investigator
Time frame: Up to approximately 28 months
ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
42 secondary outcomes
Part 1 and 2: Maximum observed concentration (Cmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin
Time frame: Up to approximately 31 months
Part 1 and 2: Time to reach Cmax (Tmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin
Time frame: Up to approximately 31 months
Part 1 and 2: Area under the concentration-time curve (AUC) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin
Time frame: Up to approximately 31 months
Part 1- Confirmed Objective Response Rate assessed by investigator
Time frame: Up to approximately 31 months
Part 1 and 2: Duration of response (DoR) assessed by investigator
Time frame: Up to approximately 31 months
Part 1 and 2: Progression-free survival (PFS) assessed by investigator
Time frame: Up to approximately 31 months
Part 1 and 2: Number of participants with treatment-emergent Anti-drug antibodies (ADA) / Neutralizing antibody (NAb)
Time frame: Up to approximately 31 months
Part 1 and 2: Titers of ADA to Mocertatug Rezetecan
Time frame: Up to approximately 31 months
Part 1 and 2: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately 31 months
Part 1 and 2: Change from baseline in body temperature (degree Celsius)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in respiratory rate (breaths per minute)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in pulse rate (beats per minute)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in weight [kilogram (kg)]
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Estimated glomerular filtration rate (eGFR) (milliliter per minute)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Prothrombin Time (PT), Partial thromboplastin time (PTT) or Activated Partial Thromboplastin Time (aPTT) (seconds)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in CA-125 tumor marker among ovarian cancer participants [units per milliliter (U/mL)]
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Thyroid stimulating hormone (TSH) [microunits per milliliter (µU/mL)]
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in free thyroxine (T4) [nanograms per deciliter (ng/dL)]
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
Time frame: Baseline (Day -1) and up to approximately 31 months
Part 2: Overall Survival (OS)
Time frame: Up to approximately 31 months
Part 2-Confirmed Objective Response Rate (ORR) assessed by BICR
Time frame: Up to approximately 31 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 42850140Lheureux S, Provencher D, Baka S, Kowalyszyn R, Schutte T, Urun Y, Zeng X, Oaknin A, Lorusso D, Ray-Coquard I, Moreno V, Jalkanen K, Liu Burstrom L, van Dongen MGJ, Boni V, Lee JY, Bedard PL, Malinowska IA, Kaisermann M, McKean W. BEHOLD-1 and -2: phase 1/2 randomized studies evaluating the B7 homolog 4 protein-targeted antibody-drug conjugate mocertatug rezetecan in patients with solid tumors, including endometrial and ovarian cancers. Int J Gynecol Cancer. 2026 Sep 7:105607. doi: 10.1016/j.ijgc.2026.105607. Online ahead of print.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
65 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mocertatug rezetecan in people with Solid Tumors and Neoplasms, run by GlaxoSmithKline at 65 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Spain, Canada, Italy, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of participants with dose limiting toxicity (DLT) (time frame: Up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06431594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.