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

NCT04089189 | Completed Phase 2 DMC

• 1 other identifier: IMP4297-2018-CN01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

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

  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)

• DOR

  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

• FPS

  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

• DCR

  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

• CBR

  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

• OS

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

Study Arms (1)

IMP4297

EXPERIMENTAL

100 subjects to receive IM4297 orally.

Drug: IMP4297

Interventions

IMP4297 DRUG

IMP4297 100mg PO QD

IMP4297

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 2\) Female subjects ≥ 18 years of age with histologically or cytologically confirmed advanced non-mucinous ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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)

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (1)

Xiaohua.Wu

Shanghai, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

senaparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 13, 2019
• Study Start: October 28, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 17, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)