ClinicalTrials.gg
Not yet recruitingNCT07821606HS-20089 PSOCUpdated Sep 16, 2026

Phase III Study of HS-20089 With Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer

A Phase 3 interventional study of HS-20089+Bevacizumab and Dose 2:arboplatin+Paclitaxel+Bevacizumab in Platinum-sensitive Recurrent Ovarian Cancer, sponsored by Hansoh BioMedical R&D Company. Not yet recruiting at 39 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Hansoh BioMedical R&D Company (part of Hansoh Pharmaceutical Group Company Limited) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This is a Phase III study evaluating the efficacy of HS-20089 in combination with bevacizumab versus investigator's choice of platinum-based chemotherapy in combination with bevacizumab in participants with platinum-sensitive recurrent ovarian cancer (PSOC).

02

Conditions studied

  • Platinum-sensitive Recurrent Ovarian Cancer

Browse trials for

03

In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's planned enrollment of 460 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Hansoh BioMedical R&D Company is the lead sponsor of 48 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

The main criteria are as follows:

  1. Female, aged 18 years or older (≥18 years)
  2. Willing to voluntarily participate in this clinical trial, understand the study procedures, and able to provide written
  3. Platinum-sensitive recurrence
  4. PS: 0-1
  5. Expected survival of more than 12 weeks.
  6. Women of must be willing to use appropriate measures from the time of signing informed consent until 6 months after the last dose administration and should not be breastfeeding.
  7. Must be able to provide sufficient fresh or archived tumor tissue specimens that meet the requirements.

Exclusion criteria

Exclusion Criteria:

  • 1. Prior treatment with topoisomerase I inhibitors; cytotoxic chemotherapy agents; small molecule inhibitors; antibody-drug conjugates (ADCs).

    2. Prior major surgery within 4 weeks prior to radonmization. 3. Residual toxicity from previous treatments graded ≥ Grade 2 according to the (CTCAE) version 6.0.

    4. History of a second primary . 5. Pleural effusion/ascites requiring clinical intervention); presence of pericardial effusion.

    6. Imaging evidence of bowel obstruction or symptoms/signs suggestive of bowel obstruction.

    7 History of gastrointestinal perforation or fistula, or any grade of intra-abdominal abcess within 3 months prior to randonmization.

    8 Participants known to have central nervous system (CNS) and/or carcinomatous meningitis, either previously diagnosed or identified during screening.

    9 Severe or poorly controlled hypertension. 10 bleeding symptoms 11 History of severe arterial/venous thromboembolic events 12. Clinically significant active viral, bacterial, or fungal infections requiring intravenous or oral pharmacological treatment 13. Known presence of an active infectious disease 14. History of interstitial lung disease of any grade

Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
460 participants (estimated)

Study arms

  • Experimental
    Treatment group 1

    Experimental,Treatment group 1: HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.

    Drug: HS-20089+Bevacizumab

  • Active comparator
    Treatment group 2-4

    Active Comparator,Treatment group 2-4,Carboplatin+Paclitaxel/Gemcitabine/Doxorubicin Hydrochloride Liposome+Bevacizumab:administered according to the study protocol and as assessed by the investigator

    Drug: Dose 2:arboplatin+Paclitaxel+Bevacizumab · Drug: Dose 3:arboplatin+Gemcitabine+Bevacizumab · Drug: Dose 4:arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab

Interventions

  • DrugHS-20089+Bevacizumab

    Drug pages: Mocertatug rezetecan · Bevacizumab

    Experimental(Treatment group 1):HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.

  • DrugDose 2:arboplatin+Paclitaxel+Bevacizumab

    Active Comparator(Treatment group2): Investigators selected treatment regimens based on participants' conditions(Paclitaxel or Doxorubicin Hydrochloride Liposome or Gemcitabine).All subjects will receive the investigator-selected drug in combination with Carboplatin and Bevacizumab, administered according to the study protocol and as assessed by the investigator.

  • DrugDose 3:arboplatin+Gemcitabine+Bevacizumab

    Active Comparator(Treatment group3): Investigators selected treatment regimens based on participants' conditions(Paclitaxel or Doxorubicin Hydrochloride Liposome or Gemcitabine).All subjects will receive the investigator-selected drug in combination with Carboplatin and Bevacizumab, administered according to the study protocol and as assessed by the investigator.

  • DrugDose 4:arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab

    Active Comparator(Treatment group4): Investigators selected treatment regimens based on participants' conditions(Paclitaxel or Doxorubicin Hydrochloride Liposome or Gemcitabine).All subjects will receive the investigator-selected drug in combination with Carboplatin and Bevacizumab, administered according to the study protocol and as assessed by the investigator.

06

What researchers measure

Primary outcomes

  1. PFS assessed by BICR

    Progression-free Survival (PFS) assessed by blinded independent central review (BICR) according to RECIST v1.1 criteria in the ITT population

    Time frame: Screening up to 3years

Secondary outcomes

  1. PFS assessed by the investigator

    Progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 criteria in the ITT population

    Time frame: Screening up to 3 years(Planned date)

  2. OS

    Overall survival (OS) in the ITT population

    Time frame: Through study completion, an average of 5 years

  3. ORR

    Objective response rate (ORR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population;

    Time frame: Screening up to study completion,with an average of 5 years

  4. DCR

    Disease control rate (DCR) assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population;

    Time frame: Screening up to study completion, with an average of 5 years

  5. DoR

    Duration of response (DoR) is defined as the time from the date of first documentation of objective response (complete response (CR) or partial response (PR) to the documentation of objective progression or to death due to any cause, whichever occurs first, as assessed by BICR and by the investigator according to RECIST v1.1 criteria in the ITT population.

    Time frame: Screening up to study completion, with an average of 5 years

  6. TFST

    Time to first subsequent treatment (TFST) is defined as the time from randomization to the date of initiation of the first subsequent anticancer therapy or death from any cause, whichever occurs first, as assessed by the investigators in the ITT population

    Time frame: Screening up to study completion, with an average of 5 years

  7. PSF2

    Pogression-free survival 2 (PFS2) is defined as the time from randomization to the date of subsequent disease progression following the first investigator-assessed disease progression or death from any cause, whichever occurs first, in the ITT population.

    Time frame: Screening up to study completion, with an average of 5 years

07

Study locations

39 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.

Of 73 industry-sponsored phase 3 interventional studies under Ovarian Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 72. This study's planned 37 months is below that.

Counting every sponsor, half of 125 studies reached it within 59 months; a quarter within 37 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 16, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Dec 30, 2029
CompletionEst.
Dec 30, 2031
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07821606
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 30, 2029 (estimated)
Completion
Dec 30, 2031 (estimated)
Last update
Sep 16, 2026

Study contacts

Ding Ma, PhD
Contact
dingma424@126.com
0086-27-83662384
Qinglei Gao, PhD
Contact
qingleigao@hotmail.com
0086-27-83662384

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Mocertatug rezetecan · Bevacizumab

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