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Recurrent Ovarian CancerPhase 1/2NCT06308406

A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer

A Phase 1/2 study testing Bevacizumab； HRS-1167 in people with Recurrent Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 18 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Recurrent Ovarian Cancer
What is being tested?
Bevacizumab； HRS-1167
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
18 sitesChina
Study dates
15 Mar 2024to Oct 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily join this study, sign the informed consent form, have good compliance, and be able to cooperate with the follow-up.
  • Age 18~75 years old.
  • Cytologically or histologically confirmed diagnosis of recurrent epithelial ovarian, fallopian tube, or primary peritoneum cancer.
  • Patient has been previously treated with a platinum-containing regimen and has been treated with a platinum-based regimen during the last dose of platinum-based therapy (self-treatment initiation to within 1 month after the last dose) efficacy is non-PD, 6 months after the end of treatment (183 disease progression or recurrence within calendar days, and the number of lines of systemic therapy after platinum resistance ≤1 line.
  • At least one measurable lesion per RECIST v1.1 criteria.
  • ECOG PS score: 0-1 points.
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  • Expected survival period ≥ 3 weeks.
  • Good level of organ function.
  • Subjects of childbearing potential who need to use highly effective contraception from the time of signing informed to 210 days after the last dose of trial drug; Subjects of childbearing potential must have a negative serum HCG within 7 days prior to the first dose and must be non-lactating.

Who cannot join

  • Those who have received chemotherapy, immune checkpoint inhibitors, major surgical operations, anti-tumor vaccines within 4 weeks before the first dose; Those who have received palliative radiotherapy within 2 weeks prior to the first dose; Oral molecularly targeted therapy (including other clinical trial targeted agents) 5 drug half-lives or 4 weeks (whichever is shorter) < from the first study dose; Those who have received a live vaccine within 4 weeks prior to the first dose or possibly during the study.
  • Toxicity due to prior antineoplastic therapy has not recovered according to NCI-CTCAE v5.0 grade≤ Level 1.
  • Subject has previous or concurrent other malignancies.
  • Subject has carcinomatous meningitis, or has untreated central nervous system metastases.
  • Imaging shows tumor invasion of large blood vessels or unclear demarcation from blood vessels; or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels and causing fatal hemorrhage during treatment.
  • Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose of the drug.
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  • Severe bone injury due to tumor bone metastases, including severe bone pain with poor control, pathological fractures of important sites and spinal cord that have occurred within the last 6 months or are expected to occur in the near future oppression, etc.
  • Previous or current interstitial pneumonitis/interstitial lung disease (except for those with radiographic changes only), pneumonia requiring systemic treatment with glucocorticoids (such as radiation pneumonitis, etc.); Current active pneumonitis or those with severe impairment of lung function confirmed by pulmonary function tests.
  • People who are known to be allergic to bevacizumab or have had a severe allergic reaction to other monoclonal antibodies.
  • Those with active tuberculosis; Those who have been adequately treated before the first dose and have discontinued anti-tuberculosis therapy for ≥ 3 months can be enrolled.
  • Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg); Previous hypertensive crisis or hypertensive sex encephalopathy.
  • Have clinical symptoms or disease of the heart that are not well controlled.
  • Coagulation abnormalities, bleeding tendency, or those receiving thrombolytic or anticoagulant therapy are allowed to receive low-dose low-molecular-weight heparin or oral aspirin prophylactic anticoagulation therapy during the trial.
  • NCI-CTCAE v5.0 grade ≥2 bleeding events within 4 weeks prior to the first dose, including but not limited to hemoptysis (hemoptysis in a single episode ≥2mL), vaginal bleeding, gastrointestinal bleeding, etc.
  • Experienced arterior/venous thrombotic event within 6 months prior to the first dose.
  • Patients with gastrointestinal perforation or fistula (except artificial fistula), urethral fistula, intra-abdominal abscess, intestinal obstruction, or those requiring parenteral nutrition within 3 months prior to the first dose.
  • Those who are unable to swallow tablets normally, or have abnormal gastrointestinal function, which may affect drug absorption as judged by the investigator.
  • Subjects who have had a serious infection within 1 month before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; Subjects with any active infection requiring intravenous system therapy, or who have a progeny during the screening period, prior to the first dose 38.5°C due to unknown fever>; Those who have used antibiotics within 2 weeks before the first dose.
  • Known history of positive human immunodeficiency virus (HIV) test; Known active hepatitis.
  • Treatment with a strong inhibitor of CYP3A4, CYP2D6, P-gp, or BCRP, <5 drug half-lives or 14 days from the date of first dose; Treatment with the above enzyme strong inducers was 28 days < the first dose.
  • As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (such as severe diabetes, thyroid disease, spinal cord compression, superior vena cava syndrome, psychiatric diseases) that require concomitant treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subjects.

Trial locations and contacts

18 sites in 1 country.

Xin Xu contact

0518-82342973

xin.xu@hengrui.com

Yuting Wang contact

0518-82342973

yuting.wang@hengrui.com

18 sites in 1 country

China18 sites, 18 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Lingying Wu

    Not yet recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Hong Zheng

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Jing Wang

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610042

    Guonan Zhang

    Not yet recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

    Yu Huang

    Not yet recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Junying Tang

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

    Tao Zhu

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150001

    Ge Lou

    Not yet recruiting

  • First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui, 230002

    Ying Zhou

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

    Hualei Bu

    Not yet recruiting

  • Shandong First Medical University Affiliated Cancer Hospital

    Jinan, Shangdong, 250117

    Liang Chen

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Hongying Yang

    Not yet recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530022

    He Wang

    Not yet recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

    Danbo Wang

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050001

    Hui Zhang

    Not yet recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030006

    Hongwei Zhao

    Not yet recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300000

    Ke Wang

    Not yet recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    Qinglei Gao

    Not yet recruiting

Other trials in China

About this study

This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer.

Being tested
Bevacizumab； HRS-1167
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab； HRS-1167Drug

    Bevacizumab: injection, 100mg(4mL), intravenous infusion HRS-1167: Tablets, 25mg/tablet, oral

Study groups in NCT06308406
Study groupRoleWhat they receive
HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancerExperimentalNot described
Receives: Drug: Bevacizumab； HRS-1167

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of subjects with dose-limiting toxicity (DLT)

    Measured: From first dose of study treatment until the end of Cycle 1（up to 21 days）

  2. Determination of Recommended Phase II dose (RP2D)

    Measured: From first dose of study treatment until the end of Cycle 1（up to 21 days）

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.

    Measured: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)]

  2. Disease Control Rate (DCR)

    The percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 15 weeks after start of treatment

    Measured: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)

  3. Duration of Response (DoR)

    The time from the date of first response until date of disease progression or death in the absence of disease progression.

    Measured: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)

  4. Progression free Survival (PFS)

    Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death

    Measured: From time of fist dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)

  5. Overall Survival (OS)

    The time until death due to any cause.

    Measured: From time of first dose of HRS-1167 or Bevacizumab until the date of death (up to 24 months)

  6. Time To Response(TTR)

    Time from C1D1 to complete or partial response, according to RECIST v1.1 criteria.

    Measured: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start15 Mar 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308406
Sponsor's protocol ID
HRS-1167-201-Bev
Status last verified
Feb 2024
First submitted
26 Feb 2024
Last updated
11 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bevacizumab； HRS-1167 in people with Recurrent Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 18 sites 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 9 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Xu (0518-82342973, xin.xu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of subjects with dose-limiting toxicity (DLT) (time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308406.

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 11 Apr 2024.

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