Sarcoma
Conditions
Interventions
Cohort 1A (Ris-Rez)
Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]
Cohort 2 (Ris-Rez)
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all the following criteria apply - 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% foradolescent participants, with no deterioration in the 2 weeks prior to first dose/randomization. - Has adequate organ function. - All participants, or their legal guardians, must provide signed informed consent and agree to follow the study protocol before starting any study activities
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following key exclusion criteria apply: - 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). - Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases. - Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention. - Is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 - Cohort 1 & 2: Number of participants with a change from baseline in body weight - Cohort 1 & 2: Number of participants with a change from baseline in laboratory parameters (haematology and clinical chemistry) - Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG) - Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status - Cohort 2: PFS* rate at week 18 (PFS18) - Cohort 1 & 2: Duration of response (DoR**) - Cohort 1 & 2: PFS* rate at week 30 (PFS30) - Cohort 1 & 2: PFS* - Cohort 1 & 2: Unconfirmed ORR*** - Cohort 1 & 2: Observed pharmacokinetic (PK) concentration of Ris-Rez (conjugated antibody) and payload - Cohort 1 & 2: Proportion of participants with positive and total Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez - Cohort 1 & 2: Titers of ADA against Ris-Rez - Cohort 1 & 2: Participant-reported experience on study treatment * 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 ** 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 *** 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. | — |
Countries
Japan, TBD
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed