Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors

NCT05269316 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IMP9064-101
• Study Type: interventional
• Target: 61
• Locations: 4 countries
• Sites: 8

Brief Summary

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of IMP9064 as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors

Conditions

Solid Tumor; Advanced Solid Tumor

Keywords

Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (Safety and Tolerability)

  Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)

  11 months

• To determine the Maximum Tolerable Dose

  Maximum Tolerable Dose (if any)/Recommended Phase 2 Dose of IMP9064 monotherapy

  11 months

Secondary Outcomes (8)

• To determine Maximum concentration (Cmax)

  11 months

• To determine area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)

  11 months

• To assess Overall response rate (ORR)

  11 months

• To assess Disease control rate (DCR)

  11 months

• To assess Duration of response(DOR)

  11 months

Study Arms (1)

IMP9064 Monotherapy

EXPERIMENTAL

Dose-escalation IMP9064 administered orally on empty stomach once/twice daily

Drug: IMP9064

Interventions

IMP9064 DRUG

IMP9064 Monotherapy administered for 21 days

IMP9064 Monotherapy

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age on the day of signing informed consent form (ICF) (at the time of screening for Part 1 and Part 2C and pre-screening for Part 2A and Part 2B).
• Must voluntarily participate in the study and be willing and able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Male or female patients with histologically or cytologically confirmed AST refractory to or intolerant of available standard-of-care therapy or for which no standard treatment exists.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Part 1) at screening.
• Provision of tumor tissue samples.
• Life expectancy ≥ 12 weeks (according to Investigator's judgement).
• Female patients should meet at least 1 of the following criteria before they can participate in the study:
• Females who have no childbearing potential (i.e. physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
• Post-menopausal (total cessation of menses for ≥ 1 year).
• Females of childbearing potential should have a negative serum pregnancy test during the screening period (within 7 days prior to the first dose of the study drug), should not be in lactation, and should be willing to practice a highly effective contraceptive method throughout the study period (from study entry up to 6 months after the last dose of the study drug). A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly (See Appendix 4, Section 11.4).
• Male patients are eligible to participate in the study if they have undergone vasectomy or agree to use a highly effective method of contraception and refrain from donating sperms from study entry up to 6 months after the last dose of the study drug.
• Willing and able to comply with study visits and study-related procedures.
• For optional PD analysis in Part 1, patients should be willing provide hairs plucked from eyebrows pre and post treatment with IMP9064 and fresh tumor biopsies (if deemed necessary by SMC) pre and post treatment with IMP9064.

You may not qualify if:

• Known history of hypersensitivity to any components of the study drug.
• Any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy and herbal/alternative therapies with anti-cancer indications, or targeted therapy) administered within 28 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
• Any previous treatment-related toxicities have not recovered, i.e. to ≤ Grade 1, as evaluated by NCI-CTCAE version 5.0 or baseline, except alopecia and anemia. Patients with chronic Grade 2 toxicities which are well managed and stable may be eligible per the discretion of the investigator after the discussion with the Sponsor and medical monitor, e.g., Grade 2 chemotherapy-induced neuropathy.
• Primary tumor in CNS, or active or untreated CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior to dosing with study drug. Patients on low dose corticosteroids (\< 20 mg prednisone or equivalent per day) may participate.
• Clinically significant cardiovascular condition, including:
• History of congestive heart failure (New York Heart Association \[NYHA\] Class \> 2)
• History of unstable angina
• New-onset angina or myocardial infarction within the 6 months prior to the first dose of study drug
• New onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within the 6 months prior to the first dose of study drug and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed provided the condition is stably controlled.
• History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QTcF \> 470 msec for females, QTcF \> 450 msec for males by Fridericia formula at screening, pacemaker installation or previous diagnosis of congenital long QT syndrome).
• Patients who have undergone a major surgery or have undergone a radical radiotherapy within 28 days prior to the first dose of study drug or have undergone a palliative radiotherapy within 14 days prior to the first dose of study drug, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to first dose of study drug.
• Patients with infections, including:
• An uncontrolled acute infection, or an active infection requiring systemic treatment, or patients who have received systemic antibiotics within 14 days prior to the first dose of the study drug; prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as there is no violation with the requirement of concomitant medications.
• A known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome or positive HIV testing should undergo CD4+ T-cell test during the screening period. Patients with CD4+ T-cell counts \< 350 cells/μL are ineligible for enrolment as well as patients with unknown HIV infection status who are unwilling to undergo HIV testing.
• A known active hepatitis B or C. To be included in the study, patients with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during screening must be further tested for hepatitis B virus (HBV) DNA titer (excluding patients with a DNA titer of more than 2500 copies \[cps\]/mL or 500 IU/mL) and HCV ribonucleic acid (RNA) (excluding patients with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, patients with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 copies \[cps\]/mL or 500 IU/mL) and hepatitis C infected patients who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled. Note: If the lower detection limit of the HBV DNA assay is higher than 2500 copies \[cps\]/mL or 500 IU/mL, the patients with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled.

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (8)

Hackensack University Medical Center PARTNER

Hackensack, New Jersey, 07601, United States

COMPLETED

Mount Sinai

New York, New York, 10029, United States

COMPLETED

Greenville Hospital System University Medical Center (ITOR)

Greenville, South Carolina, 29605, United States

COMPLETED

Mary Crowley Cancer Research Centers

Dallas, Texas, 75251, United States

COMPLETED

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

COMPLETED

Linear Clinical Research Limited

Nedlands, 6009, Australia

COMPLETED

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

COMPLETED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xiangna Chen

CONTACT

+86-021-68411121; xiangna.chen@impacttherapeutics.com

Study Design

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

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 7, 2022
• Study Start: February 11, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); TW (1); US (4); CN (1)