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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513860-25 | Registry Identifier | CTIS |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants with advanced solid tumors who are refractory or intolerant to established standard therapies |
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| Part 2: Dose Expansion | Experimental | Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mocertatug rezetecan | Drug | Mocertatug rezetecan will be administered |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with dose limiting toxicity (DLT) | 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) | Up to approximately 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Maximum observed concentration (Cmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin | 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 |
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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
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
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
Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Birmingham | Alabama | 35294 | United States |
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/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| 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 | 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 | 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 | 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). | Up to approximately 31 months |
| Part 1 and 2: Number of participants with treatment-emergent Anti-drug antibodies (ADA) / Neutralizing antibody (NAb) | Up to approximately 31 months |
| Part 1 and 2: Titers of ADA to Mocertatug Rezetecan | 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) | Up to approximately 31 months |
| Part 1 and 2: Change from baseline in body temperature (degree Celsius) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in respiratory rate (breaths per minute) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in pulse rate (beats per minute) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)] | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in weight [kilogram (kg)] | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in white blood cell count (cells per microliter) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from Baseline in Platelet count (cells per microliter) | 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) | 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) | 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) | 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) | 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 | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter) | 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) | 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) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR) | 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 | 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) | 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 | 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) | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio) | 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)] | 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)] | 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)] | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)] | Baseline (Day -1) and up to approximately 31 months |
| Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage] | 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. | 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 | 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) | 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 | 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). | Up to approximately 31 months |
| GSK Investigational Site | Recruiting | Fountain Valley | California | 92708 | United States |
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| GSK Investigational Site | Recruiting | Santa Rosa | California | 95403 | United States |
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| GSK Investigational Site | Completed | Lake Mary | Florida | 32746 | United States |
| GSK Investigational Site | Recruiting | Orlando | Florida | 32827 | United States |
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| GSK Investigational Site | Recruiting | Fairway | Kansas | 66205 | United States |
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| GSK Investigational Site | Recruiting | Boston | Massachusetts | 02114 | United States |
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| GSK Investigational Site | Recruiting | Boston | Massachusetts | 02215 | United States |
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| GSK Investigational Site | Recruiting | Detroit | Michigan | 48201 | United States |
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| GSK Investigational Site | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| GSK Investigational Site | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| GSK Investigational Site | Recruiting | Mineola | New York | 11501 | United States |
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| GSK Investigational Site | Recruiting | New York | New York | 10016 | United States |
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| GSK Investigational Site | Recruiting | Portland | Oregon | 97213 | United States |
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| GSK Investigational Site | Recruiting | Nashville | Tennessee | 37203 | United States |
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| GSK Investigational Site | Recruiting | Dallas | Texas | 75230 | United States |
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| GSK Investigational Site | Recruiting | West Valley City | Utah | 84119 | United States |
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| GSK Investigational Site | Recruiting | Seattle | Washington | 98104 | United States |
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| GSK Investigational Site | Recruiting | Cipoletti Rio Negro | R8324CVE | Argentina |
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| GSK Investigational Site | Recruiting | Ciudad de Buenos Aires | 1118 | Argentina |
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| GSK Investigational Site | Recruiting | La Plata | B1900AVG | Argentina |
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| GSK Investigational Site | Recruiting | Rosario | S2002 | Argentina |
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| GSK Investigational Site | Recruiting | Blacktown | New South Wales | 2148 | Australia |
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| GSK Investigational Site | Recruiting | Macquarie University | New South Wales | 2109 | Australia |
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| GSK Investigational Site | Recruiting | Leuven | 3000 | Belgium |
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| GSK Investigational Site | Recruiting | Barretos | 14784-400 | Brazil |
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| GSK Investigational Site | Recruiting | Goiânia | 74605-070 | Brazil |
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| GSK Investigational Site | Recruiting | Rio de Janeiro | 20220-410 | Brazil |
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| GSK Investigational Site | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| GSK Investigational Site | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| GSK Investigational Site | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| GSK Investigational Site | Recruiting | Montreal | Quebec | H2X 0A9 | Canada |
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| GSK Investigational Site | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| GSK Investigational Site | Recruiting | Helsinki | 00180 | Finland |
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| GSK Investigational Site | Recruiting | Helsinki | 00290 | Finland |
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| GSK Investigational Site | Recruiting | Tampere | 33520 | Finland |
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| GSK Investigational Site | Recruiting | Lyon | 69373 | France |
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| GSK Investigational Site | Recruiting | Saint-Herblain | 44805 | France |
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| GSK Investigational Site | Recruiting | Villejuif | 94805 | France |
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| GSK Investigational Site | Recruiting | Aviano PN | 33081 | Italy |
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| GSK Investigational Site | Recruiting | Milan | 20141 | Italy |
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| GSK Investigational Site | Recruiting | Milan | 20159 | Italy |
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| GSK Investigational Site | Recruiting | Naples | 80131 | Italy |
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| GSK Investigational Site | Recruiting | Roma | 00168 | Italy |
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| GSK Investigational Site | Recruiting | Saitama | 350-1298 | Japan |
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| GSK Investigational Site | Recruiting | Shizuoka | 411-8777 | Japan |
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| GSK Investigational Site | Recruiting | Tokyo | 135-8550 | Japan |
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| GSK Investigational Site | Recruiting | Amsterdam | 1066 CX | Netherlands |
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| GSK Investigational Site | Recruiting | Gyeonggi-do | 10408 | South Korea |
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| GSK Investigational Site | Recruiting | Seoul | 03080 | South Korea |
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| GSK Investigational Site | Recruiting | Seoul | 03722 | South Korea |
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| GSK Investigational Site | Recruiting | Seoul | 06351 | South Korea |
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| GSK Investigational Site | Recruiting | Barcelona | 08035 | Spain |
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| GSK Investigational Site | Recruiting | Córdoba | 14004 | Spain |
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| GSK Investigational Site | Recruiting | Girona | 17007 | Spain |
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| GSK Investigational Site | Recruiting | Madrid | 28027 | Spain |
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| GSK Investigational Site | Recruiting | Madrid | 28034 | Spain |
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| GSK Investigational Site | Recruiting | Madrid | 28040 | Spain |
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| GSK Investigational Site | Recruiting | Madrid | 28046 | Spain |
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| GSK Investigational Site | Recruiting | Pozuelo de AlarcOn Madr | 28223 | Spain |
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| GSK Investigational Site | Recruiting | Stockholm | 17164 | Sweden |
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| GSK Investigational Site | Recruiting | Uppsala | SE-751 85 | Sweden |
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| GSK Investigational Site | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
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| GSK Investigational Site | Recruiting | London | NW1 2PG | United Kingdom |
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| GSK Investigational Site | Recruiting | London | W1G 6AD | United Kingdom |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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