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Ovarian CancerPhase 2SABRINANCT04089189

Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer

A Phase 2 study testing IMP4297 in people with Ovarian Cancer, run by Impact Therapeutics, Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase II, multi-center, open-label, single-arm, non-randomized study to evaluate the efficacy, safety and tolerability of IMP4297 capsules in subjects with germline and/or somatic BRCA1/2 mutated advanced ovarian cancer in china 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?
IMP4297
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteChina
Study dates
28 Oct 2019to 17 Dec 2024
Phase
Phase 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects have to sign ICF prior to study-related procedures.
  • Female subjects ≥ 18 years of age with histologically or cytologically confirmed advanced non-mucinous ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer;
  • Germline and/or somatic BRCA1/2 mutation confirmed by central laboratory;
  • Disease relapse or progression after no less than 2 prior lines of platinum-based chemotherapy
  • No disease relapse or progression (based on clinical, CA125 or imaging) within 6 calendar months after the last platinum-containing regimen;
  • At least one measurable lesion confirmed by independent central imaging according to the criteria of RECIST v1.1;
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  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1 (refer to Appendix 1);
  • Expected survival time ≥ 12 weeks;
  • Subjects, of sexually active and childbearing potential, and their spouses have to use contraception during the study and 90 days after the last dose of investigational drug (refer to Appendix 6 for acceptable contraception)

Who cannot join

  • Inadequate hematopoiesis or organ function (corrective treatment with blood products ≤ 14 days prior to the first dose of investigational drug, e.g. transfusion, etc., is not allowed):
  • Absolute neutrophil count (ANC) <1.5×109/L; Hemoglobin (HGB) <9 g/dL; Platelet (PLT) <100×109/L; Total bilirubin (TBIL) >1.5 × upper limit of normal (ULN); Aspartate transferase (AST) and/or alanine aminotransferase (ALT) >3×ULN, AST and/or ALT of subjects with liver metastases >5×ULN; Creatine (Cr) >1.5 × ULN; International normalized ratio (INR) >1.5×ULN, or activated Partial thromboplastin time (aPTT) >1.5×ULN, (INR only for subjects who have not received anticoagulant therapy);
  • Have a history of radiation therapy < 4 weeks prior to the first dose of investigational drug, or chemotherapy, biological therapy, endocrine therapy or small molecule targeted therapy before the first dose of investigational drug (subject whose washout period ≥ 5 half-lives from the first dose of investigational drug can be enrolled);
  • Have received strong CYP3A4 inhibitors or strong CYP3A4 inducers prior to the first dose of investigational drug (washout period from the first dose of investigational drug ≥ 5 half-lives is allowed) or require continued treatment with these drugs during the study (as described in Section 6.9.2 of the protocol; refer to Appendix 2 for common CYP3A4 strong inhibitors or CYP3A4 strong inducers)
  • Have not recovered to NCI CTCAE v4.03 ≤ grade 1 from the toxicity of previous anti-tumor treatment, except alopecia;
  • Have had treatment with drugs targeting poly-ADP-ribose polymerase (PARP);
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  • Clinically significant active infection;
  • History of clinically significant liver disease, including active viral or other hepatitis, history of alcohol abuse or cirrhosis; except for subjects with previous viral hepatitis confirmed to be inactive by polymerase chain reaction (PCR) assay;
  • Human immunodeficiency virus (HIV) infection;
  • Have congestive heart failure graded classification II or above assessed by New York Heart Association (NYHA); history of myocardial infarction or unstable angina within 6 months before treatment; history of stroke or transient ischemic attack within 6 months before treatment;
  • Subjects with active or untreated central nervous system metastases; subjects with treated brain metastases can be enrolled if the following criteria is met:
  • Have no imaging progression ≥ 4 weeks after the end of treatment; The treatment completed ≥ 28 days prior to the first dose of investigational drug; Have no need to receive treatment with systemic corticosteroids (> 10 mg/day prednisone or equivalent) ≤ 14 days prior to the first dose of investigational drug;
  • Pregnant or lactating women
  • Subjects who had intestinal obstruction within 12 weeks prior to the first dose of investigational drug;
  • History of other malignancy within 5 years prior to the first dose of investigational drug;
  • Have had major surgery within 4 weeks prior to the first dose of investigational drug;
  • Subjects, at the discretion of the investigator, with poor compliance or with any factors unsuitable for participation in this trial; subjects, at the discretion of the investigator, to be unsuitable for participation in this study due to any clinical or laboratory abnormality.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiaohua.Wu

    Shanghai

Other trials in China

About this study

Official title: A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of IMP4297 Capsules in Subjects With Germline and/or Somatic BRCA1/2 Mutation Positive Advanced Ovarian Cancer With at Least 2 Prior Lines of Standard Systemic Therapy

A phase II, multi-center, open-label, single-arm, non-randomized study to evaluate the efficacy, safety and tolerability of IMP4297 capsules in subjects with germline and/or somatic BRCA1/2 mutated advanced ovarian cancer in china

Read the detailed description

A total of 100 subjects with germline and/or somatic BRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety, tolerability and PK profile of IMP4297.

The primary objective is to assess ORR in subjects with germline and/or somatic BRCA1/2 mutated advanced ovarian cancer with at least 2 prior lines of standard systemic therapy treated with IMP4297 capsules by independent imaging according to RECIST v1.1. Subjects will be treated until there is evidence of disease progression or any other discontinuation criterion is met. Best supportive care will be provided to all subjects and will be decided by investigators if there are no other specific restrictions within the protocol.

Four to seven blood samples (approximately 2 mL/sample) are planned to be collected for each enrolled subject for the popPK and/or dose-response evaluation. Sample collection visits are planned on Cycle (C) 1 Day (D) 1, C1D15, C2D1, C3D1 and C4D1. The actual administration time, dose and blood collection time should be accurately recorded.

Conditions
Ovarian Cancer
Being tested
IMP4297
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • IMP4297Drug

    IMP4297 100mg PO QD

Study groups in NCT04089189
Study groupRoleWhat they receive
IMP4297Experimental100 subjects to receive IM4297 orally.
Receives: Drug: IMP4297

What is being measured

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

  1. ORR

    Disease response as determined by Overall Response Rate per RECIST Version 1.1

    Measured: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death，whichever came first, assessed up to 24 months

Secondary outcomes (6)

  1. DOR

    Disease response as determined by Duration of Response per RECIST Version 1.1

    Measured: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death，whichever came first, assessed up to 24 months

  2. FPS

    Disease response as determined by Progression Free Survival per RECIST Version 1.1

    Measured: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death，whichever came first, assessed up to 24 months

  3. DCR

    Disease response as determined by Disease Control Rate per RECIST Version 1.1

    Measured: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death，whichever came first, assessed up to 24 months

  4. CBR

    Disease response as determined by Clinical Benefit Rate per RECIST Version 1.1

    Measured: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death，whichever came first, assessed up to 24 months

  5. OS

    Disease response as determined by overall survival

    Measured: From enroll until subject's withdrawal of informed consent form (ICF) and/or death，whichever came first, assessed up to 24 months

  6. Incidence of Treatment-Emergent Adverse Events

    Treatment-Emergent Adverse Events assessed by the investigator according to CTCAE 4.03

    Measured: from the day of first enrolled of study drugs up to 30 days after the last administration

Timeline

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

  1. First posted13 Sep 2019
  2. Study start28 Oct 2019
  3. Primary completion30 Jun 2023
  4. Study completion17 Dec 2024

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089189
Sponsor's protocol ID
IMP4297-2018-CN01
Acronym
SABRINA
Status last verified
Jan 2026
First submitted
3 Sep 2019
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMP4297 in people with Ovarian Cancer, run by Impact Therapeutics, Inc. 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 9 inclusion and 17 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: finished, as of the sponsor's last update on 28 Jan 2026. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death，whichever came first, assessed up to 24 months). 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 NCT04089189.

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 28 Jan 2026.

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