Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns. Researchers are developing new treatments that combine different medicines for those who do not respond to single medicine. This study is looking at how safe and tolerable Mocertatug Rezetecan (Mo-Rez) is, how the body handles it, and how well it works when used with other cancer medicines. The study will include participants with advanced solid tumors who have either not responded to standard treatments or cannot tolerate them or have no available effective treatment.
Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place.
Participant capable of giving signed informed consent including compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.
Adjuvant +/- neoadjuvant considered one line of therapy
Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently)
Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
Has had any major surgery within 28 days prior to enrolment.
Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
Has known sensitivity to study intervention components, Mo-Rez (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner, or its excipients or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
Parallel
Mo-Rez
DrugMo-Rez will be administered intravenously (IV).
Dostarlimab
DrugDostarlimab will be administered IV.
Bevacizumab
DrugBevacizumab will be administered IV.
Part A: Percentage of participants with dose limiting toxicities (DLTs)
Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Severity
Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Frequency
Part B: Confirmed Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Part A: Confirmed Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Parts A and B: Duration of response (DoR)
DoR is defined as the time from date of first documented evidence of PR or better to the date of disease progression or death due to any cause.
Parts A and B: Progression-free survival (PFS)
PFS is defined as time from the date of randomization (Part B) / first dose of study intervention (Part A or B if single arm) to the date of disease progression according to investigator assessment or death due to any cause, whichever occurs first.
Part B: Overall Survival (OS)
OS is defined as the time from randomization (or date of first dose if single arm) to the date of death due to any cause.
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