A Study of IMP4297 in Patients With Advanced Solid Tumors

NCT03508011 | Completed Phase 1 DMC

• 1 other identifier: IMP4297-2016-CN01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I, first-in-human, open-label, dose-escalation study of IMP4297 administered orally once every day to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Patients with advanced breast cancer, ovarian cancer or prostate cancer are preferred. There are two stages to this study: a dose-escalation stage and a dose-expansion stage.

Conditions

Advanced Solid Tumours; Breast Cancer; Ovarian Cancer; Prostate Cancer

Keywords

Breast Cancer; Ovarian Cancer; Prostate Cancer; Advanced solid tumours

Outcome Measures

Primary Outcomes (2)

• The AEs (adverse event) of single and multiple doses of IMP4297 administered to participants with advanced solid tumors.

  Evaluate the TEAE (treatment-emergent adverse event) of IMP4297

  Each visit after IMP4297 administrated (through study completion, an average of 10 months)

• The maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLTs) of IMP4297

  Evaluate DLT and determine the MTD

  Within 28 days after IMP4297 administrated

Secondary Outcomes (12)

• Area Under Curve [AUClast, AUCINF]

  Within 7 days after firstly single dose administrated

• Area Under Curve [AUClast, AUCINF]

  Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)

• Maximum plasma concentration (Cmax)

  Within 7 days after firstly single dose administrated

• Maximum plasma concentration (Cmax)

  Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)

• Time at which Cmax occurred (Tmax)

  Within 7 days after firstly single dose administrated

Study Arms (1)

IMP4297

EXPERIMENTAL

Drug: IMP4297

Interventions

IMP4297 DRUG

The dose levels will be escalated following a modified 3+3 dose escalation scheme.

IMP4297

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Years to 70 Years (including 18 and 75 years)
• Histologically or cytologically documented disease; incurable, advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy
• Eastern Cooperative Oncology Group performance status of 0 or 1
• In the dose expansion stage, patients with BRCA (breast carcinoma) mutation will be enrolled. Patients with breast cancer, ovarian cancer and prostate cancer are preferred.
• In the dose escalation phase, at least one assessable lesion according to the RECIST 1.1 standard; In the dose expansion phase, at least one measurable lesion according to RECIST 1.1.

You may not qualify if:

• Inadequate hematologic and organ function, defined by the following (hematologic parameters must be assessed ≥14 days after a prior treatment, if any):
• Absolute neutrophil count \<1500 cells/µL
• Hemoglobin \< 9 g/dL
• Total bilirubin \> 1.5 × the upper limit of normal (ULN), with documented liver metastases total bilirubin \> 3 × the ULN.
• Aspartate transaminase (AST) and/or alanine transaminase (ALT) \> 2.5 × the ULN, with documented liver metastases AST and/or ALT levels \> 5 × the ULN.
• Serum creatinine \> 1.5 × the ULN, or creatinine clearance \< 45 mL/min based on a documented 24-hour urine collection or Cockcroft-Gault calculation of glomerular filtration rate.
• International normalized ratio (INR) \> 1.5 × the ULN or activated partial thromboplastin time (aPTT) \> 1.5 × the ULN.
• The INR applies only to patients who do not receive therapeutic anti-coagulation.
• Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, radiotherapy within 4 weeks prior to initiation of study treatment with the following exceptions:
• Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists for prostate cancer.
• Hormone-replacement therapy or oral contraceptives.
• Palliative radiation to bone metastases \> 2 weeks prior to Day 1.
• Adverse events from prior anti-cancer therapy that have not resolved to NCI CTCAE Grade ≤ 1, except for alopecia.
• Prior therapies targeting PARP (poly-ADP ribose polymerase).
• Clinical significant active infection

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Cao J, Guo H, Ji D, Shen W, Zhang S, Hsieh CY, Xiong Cai S, Edward Tian Y, Xu C, Zhang P, Xu B. Safety, Tolerability, and Pharmacokinetics of Senaparib, a Novel PARP1/2 Inhibitor, in Chinese Patients With Advanced Solid Tumors: A Phase I Trial. Oncologist. 2023 Dec 11;28(12):e1259-e1267. doi: 10.1093/oncolo/oyad163.

  PMID: 37338150 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms

Interventions

senaparib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland 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; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• BingHe Xu, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• JunNing Cao, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: April 25, 2018
• Study Start: August 23, 2017
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)