Ovarian CancerPhase 3NCT06855069
HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
A Phase 3 study testing HS-20089, Paclitaxel and Doxorubicin in people with Ovarian Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- HS-20089, Paclitaxel and Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2025to 7 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and written informed consent.
- 18 years and older, female.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Patients must have platinum-resistant disease
- Be able to provide fresh or archived tumor tissue.
- At least one measurable lesion according to RECIST v1.1.
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- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy > 12 weeks.
- Adequate bone marrow reserve and organ function.
- Contraception is required during the trial.
Who cannot join
- Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
- Previous or co-existing malignancies.
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
- Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
- Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.
- 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.
- Other inappropriate situation considered by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
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
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.
- Conditions
- Ovarian Cancer
- Being tested
- HS-20089, Paclitaxel, Doxorubicin, Topotecan
- Keywords
- Platinum-resistant recurrent epithelial ovarian cancer, HS-20089, randomized, phase III
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20089Drug
HS-20089 dose 1
PaclitaxelDrug
Paclitaxel dose 2
DoxorubicinDrug
Doxorubicin dose 3
TopotecanDrug
Topotecan dose 4
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: HS-20089 | Experimental | Not described Receives: Drug: HS-20089 |
| Treatment group 2: Investigator's choice of chemotherapy | Active comparator | Not described Receives: Drug: Paclitaxel; Drug: Doxorubicin; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Secondary outcomes (8)
Overall Survival (OS)
Measured: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by BIRC as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by BIRC as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Adverse Events
Measured: Screening up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start13 Mar 2025
- Primary completion7 Mar 2027 (estimated)
- Study completion7 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lingying Wu, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855069
- Sponsor's protocol ID
- HS-20089-301
- Status last verified
- Dec 2025
- First submitted
- 25 Feb 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06855069
- Acronym / sponsor ID
- HS-20089-301
- Conditions
- Ovarian Cancer
- Keywords
- Platinum-resistant recurrent epithelial ovarian cancer, HS-20089, randomized, phase III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 7 Mar 2027 (estimated)
- Study completion
- 7 Mar 2029 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1: HS-20089 | Experimental | Drug: HS-20089 |
| Treatment group 2: Investigator's choice of chemotherapy | Active comparator | Drug: Paclitaxel, Drug: Doxorubicin, Drug: Topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation and written informed consent.
- 18 years and older, female.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Patients must have platinum-resistant disease
- Be able to provide fresh or archived tumor tissue.
Key exclusion criteria (8 listed)
- Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
- Previous or co-existing malignancies.
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
- Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
- Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20089HS-20089 dose 1 | Drug | Treatment group 1: HS-20089 |
| PaclitaxelPaclitaxel dose 2 | Drug | Treatment group 2: Investigator's choice of chemotherapy |
| DoxorubicinDoxorubicin dose 3 | Drug | Treatment group 2: Investigator's choice of chemotherapy |
| TopotecanTopotecan dose 4 | Drug | Treatment group 2: Investigator's choice of chemotherapy |
Primary outcome
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
8 secondary outcomes
Overall Survival (OS)
Time frame: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by BIRC as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by BIRC as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Adverse Events
Time frame: Screening up to study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lingying Wu, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20089, Paclitaxel and Doxorubicin in people with Ovarian Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingying Wu, MD ((+86)13910865483, wulingying@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1 (time frame: Screening up to study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.