The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it, and how their bodies handle the drug (how its absorbed and broken down). This research is for adolescents and adults who have either: Osteosarcoma, which is a type of bone cancer, or Soft Tissue Sarcoma, which is a type of cancer that starts in soft body tissues (like muscle, fat, or nerves). In both cancer types the cancer must have already been treated, but has come back or spread, and cant be removed by surgery
Participants must be ≥ 12 years of age.
Has histologically confirmed unresectable advanced or metastatic R/R OSA (Cohort 1) or unresectable advanced or metastatic STS (Cohort 2) that has progressed to at least one prior line of systemic therapy.
Has documented disease progression on the last line of systemic treatment as confirmed by radiological imaging
Has an ECOG performance status of 0 or 1, or Lansky PS/Karnofsky PS ≥ 70% for adolescent participants, with no deterioration in the 2 weeks prior to first dose/randomization.
Has received any prior therapy with an Antibody-drug-conjugates (ADC) with a TOPO1-inhibitor payload.
Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Has severe, uncontrolled or active cardiovascular disorders.
Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
Parallel
Ris-Rez
Biological/VaccineRis-Rez will be administered
G-CSF
Biological/VaccineG-CSF will be administered
Cohort 1: Progression free survival rate at Week18 (PFS18)
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Cohort 1 & 2: Confirmed Objective Response Rate (ORR)
Confirmed ORR is defined as the proportion of participants who have achieved a confirmed Complete Response (CR) or Partial Response PR as assessed by investigator, according to RECIST 1.1
Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity
Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death
Cohort 1 & 2: Number of participants with a change from baseline in vital signs
Number of participants will be assessed
Cohort 1 & 2: Number of participants with a change from baseline in body weight
Number of participants will be assessed
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