Breast Cancer Clinical Trial

The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors

Summary

A Phase 1 Dose Escalation and Expansion Study of IMP7068 Monotherapy in Advanced Solid Tumors

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Full Description

This is A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1 Inhibitor IMP7068 Monotherapy in Patients with Advanced Solid Tumors

The study will include a dose-escalation stage and a dose-expansion stage. The dose-escalation stage is designed to determine the maximum tolerated dose (MTD) and select recommended Phase 2 dose (RP2D) of IMP7068 monotherapy. The dose-expansion stage will be conducted with RP2D to further evaluate the preliminary anti-tumor activity, safety and tolerability.

A total of approximately 140-350 patients will be enrolled in the study.

Approximately 60-100 patients will be enrolled into Part 1 dose escalation of IMP7068 monotherapy. A total of 100 patients each with advanced solid tumor will be evaluated in Part 2 dose-expansion of IMP7068 monotherapy.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

The patient must voluntarily participate in this clinical study. Be willing and able to provide written informed consent form (ICF) prior to any study activity.
Age ≥18 years on the day of signing the ICF, males or females. Only for Korea, Age ≥19 years on the day of signing the ICF.
The enrolled patients must have histologically or cytologically confirmed advanced solid tumor that is refractory/intolerant to standard treatment or for which no standard treatment exists. The patients with known microsatellite-instability high (MSI-H) or deficient in mismatch repair (dMMR) disease are required to have received prior PD 1/PD-L1 therapy; those with known NTRK fusion are required to have received an approved TRK-inhibitor. The patients who are suitable for resection or other localized therapy that is potentially curative are not eligible.

Key Exclusion Criteria:

Patients with active or untreated known CNS metastases and/or carcinomatous meningitis should be excluded.
Patients with serious acute or chronic infections.
Patients who have received prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 7 days prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of IMP7068.
Patients who are participating in or have participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of treatment.
Patients have not recovered (i.e., to Grade ≤1 or to baseline, as evaluated by NCI-CTCAE Version 5.0) from prior anti-cancer therapy-induced AEs, except for alopecia, anorexia or CTCAE grade 2 peripheral neuropathy.
Patients who have undergone a major surgery or have undergone a radical radiotherapy within 28 days prior to the study treatment, or have undergone a palliative radiotherapy within 14 days prior to the study treatment, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the study treatment.
Patients who are unable to swallow oral medications. Patients have gastrointestinal illnesses that may clinically significantly affect the absorption of oral medication IMP7068 at discretion of investigators.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

350

Study ID:

NCT04768868

Recruitment Status:

Recruiting

Sponsor:

Impact Therapeutics, Inc.

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There are 14 Locations for this study

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Emory University Hospital
Atlanta Georgia, 30322, United States More Info
Stephen Bocarro
Contact
404-778-8670
[email protected]
Olatunji Alese, MD
Principal Investigator
University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States More Info
Joaquina Baranda, MD
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
Pamela Adkisson
Contact
502-629-2500
[email protected]
Jaspreet Grewal, MD
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States More Info
Avery Fields
Contact
972-566-3016
[email protected]
Michael Hager
Contact
214-658-1962
[email protected]
Reva Schneider, MD
Principal Investigator
Next Oncology
San Antonio Texas, 78229, United States More Info
Nicole Klein
Contact
737-610-5200
[email protected]
Romeena Momin
Contact
(210) 253-2572
[email protected]
David Sommerhalder, MD
Principal Investigator
Wuhan Union Hospital
Wuhan HB, 43003, China More Info
Wanqing Ji
Contact
027-85726685
[email protected]
Guiling Li, MD
Principal Investigator
West China 2nd University Hospital
Chengdu Sichuan, 61006, China More Info
Rutie Yin, MD
Principal Investigator
Beijing Cancer Hospital
Beijing , 10014, China More Info
Yuanyuan Zhang
Contact
15724546682
[email protected]
Lin Shen, MD
Principal Investigator
Fudan University Shanghai Cancer Center
Shanghai , 20132, China More Info
Xiao-Hua Wu, MD
Principal Investigator
Chang Gung Medical Foundation - Linkou Branch
Taoyuan TW, 333, Taiwan More Info
Yi-Ting Yang
Contact
886-989-336747
[email protected]
Hung-Chih Hsu, MD
Principal Investigator
China Medical University Hospital
Taichung , 40447, Taiwan More Info
Pei-Chen Hsu
Contact
886-4-22052121
[email protected]
Li-Yuan Bai, MD
Principal Investigator
National Cheng Kung University Hospital
Tainan , 704, Taiwan More Info
Yi-Zeng Wang
Contact
886-6-2353535
[email protected]
Yu-Min Yeh, MD
Principal Investigator
Chi Mei Hospital, Liouying
Tainan , 73657, Taiwan More Info
Yen-Hsun Chen, MD
Principal Investigator
National Taiwan University Hospital
Taipei , , Taiwan More Info
Ying-Jan Chen
Contact
886-2-23123456
[email protected]
Chia-Chi Lin, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

350

Study ID:

NCT04768868

Recruitment Status:

Recruiting

Sponsor:


Impact Therapeutics, Inc.

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