This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
450
Mocertatug rezetecan will be administered
Paclitaxel will be administered
PLD will be administered
GSK Investigational Site
Randwick, New South Wales, Australia
RECRUITINGGSK Investigational Site
Montreal, Quebec, Canada
RECRUITINGGSK Investigational Site
Montreal, Quebec, Canada
RECRUITINGProgression Free Survival (PFS) by BICR
PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
Time frame: Up to approximately 212 weeks
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 212 weeks
PFS by investigator assessment
PFS is defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first
Time frame: Up to approximately 212 weeks
Objective response rate (ORR) by BICR
ORR is defined as the percentage of participants with best overall response of either complete response (CR) or partial response (PR) per RECIST 1.1 by BICR assessment
Time frame: Up to approximately 212 weeks
Duration of Response (DOR) by BICR
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by BICR assessment to the date of first documented Progressive Disease (PD) per RECIST 1.1 by BICR assessment or death due to any cause, whichever occurs first
Time frame: Up to approximately 212 weeks
ORR by investigator assessment
ORR is defined as the percentage of participants with best overall response of either CR or PR per RECIST 1.1 by investigator assessment
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Topotecan will be administered
Gemcitabine will be administered
Pembrolizumab will be administered
Bevacizumab will be administered
GSK Investigational Site
Hyōgo, Japan
RECRUITINGGSK Investigational Site
Osaka, Japan
RECRUITINGTime frame: Up to approximately 212 weeks
DOR by investigator assessment
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator assessment to the date of first documented PD per RECIST 1.1 by investigator assessment or death due to any cause, whichever occurs first
Time frame: Up to approximately 212 weeks
PFS2
PFS2 is defined as the time from the date of randomization to the date of first documented investigator-assessed clinical or radiographical progression following the first subsequent anticancer therapy and after the progression event used for PFS, or death from any cause, whichever occurs first
Time frame: Up to approximately 212 weeks
Number of participants with Treatment-emergent adverse event (TEAEs), Adverse event of special interest (AESIs) and Treatment-emergent serious adverse event (TESAEs)
Time frame: Up to approximately 212 weeks
Number of participants with TEAEs/AESI/TESAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 212 weeks
Number of participants with changes in vital signs, laboratory tests (hematology and clinical chemistry), and Electrocardiogram (ECG)
Time frame: Up to approximately 212 weeks
Serum concentration of Mo-Rez (conjugated antibody and free payload)
Time frame: Up to approximately 212 weeks
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mo-Rez
Time frame: Up to approximately 212 weeks
Titers of ADA against Mo-Rez
Time frame: Up to approximately 212 weeks
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
The EORTC QLQ-C30 includes 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. The following domains will be measured: Global health status (GHS)/ Quality of Life (QoL), physical functioning, role functioning Participants responses on these items are . averaged and then transformed to scores . ranging from 0 to 100. Higher . score indicates better functioning or a better . overall state of health.
Time frame: Up to approximately 212 weeks
Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score
The EORTC QLQ-OV28 includes a 28-item questionnaire for evaluating ovarian cancer-specific symptoms and concerns in participants of cancer clinical studies. These include items that assess symptoms in the abdominal/gastrointestinal domain. Scores are averaged and transformed to a 0 to 100 scale; higher scores indicate a greater symptom burden, while lower scores reflect fewer symptoms.
Time frame: Up to approximately 212 weeks
Time to deterioration (TTD) of EORTC QLQ-OV28
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal/gastrointestinal symptom domain of the EORTC QLQ-OV28
Time frame: Up to approximately 212 weeks
TTD of EORTC QLQ-C30
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on any of the following EORTC QLQ-C30 domains: physical functioning, role functioning and Global Health Status (GHS)/ Quality of Life (QoL).
Time frame: Up to approximately 212 weeks
Maximum Post-baseline Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) Score
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicities in participants in cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. A subset of items selected from the PRO-CTCAE item library will be assessed. This measure captures maximum post-baseline PRO-CTCAE score for each frequency, severity and/or interference of symptomatic AEs
Time frame: Up to approximately 212 weeks
CA-125 response rate as per Gynecologic Cancer InterGroup (GCIG) criteria.
Percentage of participants with a CA-125 response will be assessed
Time frame: Up to approximately 212 weeks