Clinical trial NCT06855069: HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
Official title: A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: Platinum-resistant recurrent epithelial ovarian cancer
HS-20089
randomized
phase III
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 468
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18 years and older, female.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. Patients must have platinum-resistant disease
5. Be able to provide fresh or archived tumor tissue.
6. At least one measurable lesion according to RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
8. With a life expectancy \> 12 weeks.
9. Adequate bone marrow reserve and organ function.
10. Contraception is required during the trial.

Exclusion Criteria:

1. Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
2. Previous or co-existing malignancies.
3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
4. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
5. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
6. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.
7. Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration.
8. Other inappropriate situation considered by the investigator.

Primary outcomes:
measure: Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Screening up to study completion, an average of 1 year
measure: Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Duration of Response (DoR), assessed by site investigator as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Duration of Response (DoR), assessed by BIRC as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Disease Control Rate (DCR), assessed by BIRC as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Adverse Events
timeFrame: Screening up to study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Lingying Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: