Torvutatug samrotecan: FRa targeting antibody drug conjugate Topoisomerase I inhibitor
Bevacizumab: Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Study summary
The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to standard of care (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC)
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
* Provision of an archival FFPE tumour sample
* Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy.
* Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment
* Participants who received at least 6 cycles of PBC during the induction phase of their current line of treatment.
* Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation.
* Participants with non-progressive disease upon completion of PBC in their current line of treatment.
* Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).
Exclusion Criteria:
* Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours.
* Participants with history of (non-infectious) ILD/pneumonitis that required steroids, or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
* Participants with non-healing wound, active ulcer, or bone fracture (not applicable if not receiving bevacizumab)
* Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab)
* Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)
Primary outcome measure(s)
Progression-Free Survival (PFS) — Up to approximately 5 years PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause.
Trial sites (79)
Facility
City
Region
Status
Research Site
Anchorage
Alaska
Research Site
Columbia
Maryland
Research Site
Detroit
Michigan
Research Site
Albany
New York
Research Site
Bay Shore
New York
Research Site
Greenlawn
New York
Research Site
New Hyde Park
New York
Research Site
New York
New York
Research Site
Rego Park
New York
Research Site
Cleveland
Ohio
Research Site
Cleveland
Ohio
Research Site
Columbus
Ohio
Research Site
Mayfield Heights
Ohio
Research Site
Philadelphia
Pennsylvania
Research Site
Willow Grove
Pennsylvania
Research Site
Morgantown
West Virginia
Research Site
Auchenflower
Australia
Research Site
Blacktown
Australia
Research Site
Clayton
Australia
Research Site
Liverpool
Australia
Research Site
Porto Alegre
Brazil
Research Site
São Caetano do Sul
Brazil
Research Site
São José do Rio Preto
Brazil
Research Site
São José dos Campos
Brazil
Research Site
São Paulo
Brazil
Research Site
Teresina
Brazil
Research Site
Vitória
Brazil
Research Site
Abbotsford British Columbia
British Columbia
Research Site
Montreal
Quebec
Research Site
Montreal
Quebec
Research Site
Beijing
China
Research Site
Guangdong Province
China
Research Site
Guangzhou
China
Research Site
Wuhan
China
Research Site
Bad Homburg
Germany
Research Site
Bonn
Germany
Research Site
Brandenburg
Germany
Research Site
Gütersloh
Germany
Research Site
Homburg
Germany
Research Site
Kassel
Germany
+ 39 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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