ClinicalTrials.gg
Not yet recruitingNCT07843303Updated Oct 1, 2026

Trastuzumab Rezetecan Plus Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer

A Phase 2 interventional study of Trastuzumab Rezetecan (SHR-A1811) and Bevacizumab in Ovarian Cancer, Fallopian Tube Cancers and Primary Peritoneal Cancer, sponsored by Peking University Cancer Hospital & Institute. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment

Updated Oct 1, 2026Title changedNewly registeredGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 392 studies in Ovarian Neoplasms with a site in China — 198 open to participants now, 231 under way, 35 of them phase 3. Ovarian Neoplasms · China.

Planned enrollment
195th of 319
53 · median 83
Started
2026
with 41 others
Phase 2
106 of 392
53 open now
Primary completion
2028-09
later than 193 of 230 live
Registered
387th of 392
by date

Among the 392 studies in Ovarian Neoplasms with a site in China, this one is the 195th largest by planned enrollment of the 319 interventional ones that give a count, is one of 42 that started in 2026, is one of 106 in phase 2, reaches primary completion later than 193 of the 230 other live ones, and was the 387th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

198 of the 392 studies in Ovarian Neoplasms with a site in China are open now. Recruiting first, the newest first:

193 more — sign in →

All 198 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years to 75 Years · female · no healthy volunteers.

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02

Study summary

This study is a prospective, multicenter, single-arm, open-label phase II clinical trial.

It is planned to enroll 53 subjects with HER2-expressing (IHC 1+, 2+, or 3+) partially platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (defined as disease recurrence occurring ≥6 months and \<12 months after the completion of the last platinum-containing therapy).

The study adopts a two-stage sequential treatment strategy:

Stage 1: All enrolled subjects will receive Trastuzumab Rezetecan (4.8 mg/kg IV, Q3W) combined with Bevacizumab (7.5 mg/kg IV, Q3W). Trastuzumab Rezetecan will be administered for a maximum of 1 year, or until disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria are met, whichever occurs first; Bevacizumab will be continued until disease progression, unacceptable toxicity, or other protocol-defined reasons.

Stage 2: Upon confirmed disease progression in Stage 1, subjects will enter Stage 2 to receive platinum-based chemotherapy (e.g., Carboplatin + Paclitaxel, Carboplatin + Liposomal Doxorubicin, or Carboplatin + Gemcitabine ± Bevacizumab; Cisplatin or Nedaplatin may replace Carboplatin in cases of intolerance, including but not limited to these regimens, determined by the investigator) until subsequent disease progression or unacceptable toxicity.

The primary objective is to evaluate progression-free survival 1 (PFS1) of SHR-A1811 combined with bevacizumab based on RECIST v1.1. Secondary objectives include objective response rate (ORR), disease control rate (DCR), progression-free survival 2 (PFS2), overall survival (OS), and safety and tolerability.

03

Conditions studied

  • Ovarian Cancer
  • Fallopian Tube Cancers
  • Primary Peritoneal Cancer
04

Who can participate

Ages eligible
18 Years to 75 Years
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

  1. Voluntarily agree to participate in the study, provide written , demonstrate good compliance, and be able to cooperate with protocol-required follow-up visits.
  2. Female patients aged 18 to 75 years old (inclusive, calculated from the date of signing the informed consent form).
  3. or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (mucinous carcinoma is excluded).
  4. Received 1 to 2 and must have received prior PARP inhibitor therapy.
  5. Partially platinum-sensitive recurrence, defined as disease recurrence occurring ≥6 months but \<12 months after the completion of the last platinum-containing therapy:

    • and/or adjuvant therapy are combined and counted as 1 line of therapy;
    • Maintenance therapy does not count as a separate line of therapy;
    • Changes in treatment regimens due to reasons other than disease progression (such as intolerable toxicity) are considered part of the same line of therapy and are not counted separately.
  6. Confirmed expression status: IHC 1+, 2+, or 3+.
  7. At least one according to v1.1 criteria (longest diameter ≥10 mm on spiral CT scan, or short axis ≥15 mm for lymph nodes).
  8. performance status (PS) score: 0 to 1..
  9. Expected ≥12 weeks.
  10. Adequate function of vital organs.

Exclusion criteria

Exclusion Criteria:

  1. Central nervous system (CNS) : Untreated or active . Subjects are eligible if CNS metastases have received adequate local therapy (e.g., surgery or radiotherapy), neurological symptoms have returned to baseline (excluding residual signs or symptoms related to CNS treatment), and clinical stability has been maintained for ≥ 4 weeks prior to the first dose.
  2. Second primary , except for the following: adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma; or other malignancies that have been adequately treated with curative intent and have shown no evidence of recurrence or metastasis for >= 2 years prior to the first dose.
  3. Uncontrolled pleural effusion or ascites. Subjects are eligible if therapeutic drainage has been performed and clinical stability has been maintained for at least 2 weeks after drainage.
  4. Severe pulmonary disease: History of interstitial lung disease (ILD) or non-infectious pneumonitis (such as radiation pneumonitis) requiring systemic therapy; current or suspected ILD, non-infectious pneumonitis, or other active pulmonary inflammation; or significant pulmonary impairment including severe asthma, severe (COPD), or restrictive lung disease within 6 months prior to the first dose.
  5. Tuberculosis infection: Active pulmonary tuberculosis infection. Subjects who have received adequate and standard anti-tuberculosis therapy and have discontinued anti-tuberculosis treatment for >= 3 months prior to the first dose are eligible.
  6. Uncontrolled cardiovascular disease: Poorly controlled or serious cardiovascular disease, including but not limited to unstable angina, symptomatic congestive heart failure ( Class II-IV), acute myocardial infarction within 6 months prior to the first dose, or unstable arrhythmias requiring clinical intervention within 1 month prior to the first dose.
  7. High-risk gastrointestinal indications (perforation/fistula): Gastrointestinal perforation, gastrointestinal fistula, tracheoesophageal fistula, urethral fistula, or abdominal abscess occurring within 3 months prior to the first dose, or judged by the investigator to have a high risk of occurrence in the near future. Subjects who have undergone definitive treatments such as artificial stoma or ureteral stent placement and are evaluated by the investigator as clinically stable are eligible.
  8. Active infection: Severe infection occurring within 1 month prior to the first dose; any active infection requiring systemic intravenous antimicrobial therapy; or unexplained fever (> 38.5 deg C) from the screening period up to the first dose.
  9. Specific prior drug exposure: Prior treatment with antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor, or prior single-agent topoisomerase I inhibitor therapy (such as irinotecan, topotecan).
  10. Drug : Known hypersensitivity to any active ingredient or of Trastuzumab Rezetecan (SHR-A1811), including the antibody, payload SHR169265, and linker; known hypersensitivity to any component of Bevacizumab, or a history of severe hypersensitivity reactions.
  11. Other comprehensive risks: Any clinical condition that, in the opinion of the investigator, may increase the risk to the subject, interfere with the interpretation of study results, or preclude compliance with the study protocol.
Terms in these criteria, in plain language(17)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Metastases

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

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (estimated)

Study arms

  • Experimental
    Sequential Treatment Group

    Stage 1: SHR-A1811 (4.8 mg/kg, IV) + Bevacizumab (7.5 mg/kg, IV), Q3W, until disease progression or intolerable toxicity. Stage 2: Upon confirmed progression in Stage 1, subjects proceed to receive investigator's choice of platinum-based chemotherapy rechallenge until subsequent progression or intolerable toxicity.

    Drug: Trastuzumab Rezetecan (SHR-A1811) · Drug: Bevacizumab · Drug: Platinum-based chemotherapy

Interventions

  • Humanized anti-HER2 IgG1 monoclonal antibody conjugated with a topoisomerase I inhibitor payload (SHR169265). Administered IV at 4.8 mg/kg on Day 1 of each 21-day cycle.

  • Recombinant humanized anti-VEGF monoclonal antibody. Administered IV at 7.5 mg/kg on Day 1 of each 21-day cycle (dosing interval \>30 min after SHR-A1811).

  • DrugPlatinum-based chemotherapy

    Platinum-based chemotherapy rechallenge administered in Stage 2, selected by the investigator based on patient clinical condition (including but not limited to: Carboplatin + Paclitaxel ± Bevacizumab, Carboplatin + Pegylated Liposomal Doxorubicin ± Bevacizumab, or Carboplatin + Gemcitabine ± Bevacizumab; Cisplatin or Nedaplatin may be substituted if carboplatin is not tolerated).

06

What researchers measure

Primary outcomes

  1. PFS1

    Progression-Free Survival 1 (PFS1) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Defined as the time from the date of the first dose of study treatment to the date of first documented objective tumor progression or death due to any cause, whichever occurs first.

    Time frame: From the first dose of study treatment up to approximately 36 months.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Defined as the proportion of subjects who achieve a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) based on RECIST v1.1 criteria.

    Time frame: Up to approximately 36 months.

  2. Disease Control Rate (DCR)

    Defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) based on RECIST v1.1 criteria.

    Time frame: Up to approximately 36 months.

  3. Progression-Free Survival 2 (PFS2)

    Defined as the time from the date of the first dose of study treatment in Stage 1 to the second documented objective disease progression or death due to any cause, whichever occurs first.

    Time frame: Up to approximately 36 months.

  4. Overall Survival (OS)

    Defined as the time from the date of the first dose of study treatment to death due to any cause, calculated in the intent-to-treat (ITT) population.

    Time frame: Up to approximately 36 months.

  5. Safety and Tolerability

    Incidence, severity, and causality of adverse events (AEs) and serious adverse events (SAEs) graded according to NCI-CTCAE v5.0 criteria, as well as the proportion of dose interruptions, dose reductions, and treatment discontinuations due to treatment-related toxicities.

    Time frame: From signing the informed consent form up to 30 days after the last dose of study treatment (and up to 90 days after the last dose of bevacizumab).

07

Study locations

1 site
08

Timeline

2 registry updates 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 Oct 2026; primary completion for Sep 2028, 23 months later.

Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 23 months is below that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

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

Registered
Sep 20, 2026
First posted
Sep 28, 2026
StartEst.
Oct 22, 2026
Primary completionEst.
Sep 30, 2028
CompletionEst.
Sep 30, 2029
Last update
Oct 1, 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.
Title
Trastuzumab Rezetecan Plus Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase II,Multicenter, Single-Arm Study
Oct 1, 2026
Registered
First appeared on the registry
Sep 28, 2026
Show all 2 updates
  1. Oct 1, 2026
    Title Trastuzumab Rezetecan Plus Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase II,Multicenter, Single-Arm Study
  2. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07843303
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 22, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Oct 1, 2026

Oversight

Data monitoring committee
No
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

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Studies of the drug tested here: Trastuzumab rezetecan

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