Phase Ib/II Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

Study Identifier:
300640
CT.gov Identifier:
NCT07602777
EudraCT Identifier:
2025-523997-18
EU Trial (CTIS) Number:
2025-523997-18-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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

Main objective

• To evaluate clinical efficacy of Ris-Rez in participants with unresectable Relapsed/refractory (R/R) Osteosarcoma (OSA) (Cohort 1) who have progressed after or are intolerant to at least one prior line of systemic therapy.

• To evaluate clinical efficacy of Ris-Rez in participants with unresectable advanced or metastatic Soft tissue sarcoma (STS) (Cohort 2) who have progressed after or are intolerant to at least one prior line of systemic therapy.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Soft Tissue Sarcoma
Osteosarcoma
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
N/A
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • - Participants are eligible to be included in the study only if all of 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% for adolescent 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
  • \- 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Soft Tissue Sarcoma
Osteosarcoma