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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Ris-Rez will be administered
G-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)
Time frame: At Week 18
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
Time frame: Up to approximately 98 weeks
Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in vital signs
Number of participants will be assessed
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in body weight
Number of participants will be assessed
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in laboratory parameters (haematology and clinical chemistry)
Number of participants will be assessed
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)]
Number of participants will be assessed
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants will be assessed
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Cohort 2: PFS rate at Week 18 (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 RECIST 1.1
Time frame: At Week 18
Cohort 1 & 2: Duration of response (DoR)
DoR is defined as the time from the date of the first documented objective response (CR/PR) that is subsequently confirmed, until the date of the first documented PD or death, whichever is earlier, as assessed by investigator according to RECIST 1.1
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: PFS rate at Week 30 (PFS30)
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 RECIST 1.1
Time frame: At Week 30
Cohort 1 & 2: PFS
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 RECIST 1.1
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Unconfirmed ORR
Unconfirmed ORR is defined as the proportion of participants who have achieved a response of CR or PR (without confirmation) as assessed by the investigator according to RECIST 1.1.
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Observed pharmacokinetic (PK) concentration of Ris-Rez (conjugated antibody) and payload
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Proportion of participants with positive and total Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Titers of ADA against Ris-Rez
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Participant-reported experience on study treatment
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Time frame: Up to approximately 179 weeks
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