Solid TumorPhase 1/2NCT05269316
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
A Phase 1/2 study testing IMP9064 in people with Solid Tumor and Advanced Solid Tumor, run by Impact Therapeutics, Inc. at 8 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Solid Tumor
- What is being tested?
- IMP9064
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 11 Feb 2022to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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)
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- 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.
- Active tuberculosis.
- Positive test result for severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) test. SARS-CoV-2 test is mandatory during screening for patients who have exposure to suspected, probable, or confirmed cases of SARS-CoV-2 infection within 14 days, via a validated test per local guidance; the result should be available within 4 days prior to the first dose of study drug.
- Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the Investigator to be likely to interfere with a patient's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- Receipt of:
- Any treatment targeting the ATR/CHK1 pathway.
- Live virus or bacterial vaccine within 28 days prior to the first dose of study drug and whilst the patient is receiving study drug. Patients who require COVID-19 vaccination whilst on study drug should receive a non-live vaccine (e.g., one based on messenger RNA (mRNA) or fully inactivated/genetically modified viruses incapable of replication) (see Section 6.8.1).
- Participation in another clinical study with an investigational product administered in the last 28 days or 5 half-lives (whichever is shorter) prior to the first administration of study drug.
- An investigational device within 28 days prior to the first dose of study drug.
- Patients who may need continuous treatment with proton pump inhibitors or potassium competitive acid blockers during the study period.
- Patients who have other malignancies requiring treatment within 2 years prior to the first dose of study drug will be excluded, except for radically treated locally curable basal or squamous cell skin cancer and other malignancies that have been treated with no relapse within 2 years. Presence of other active invasive cancers will be excluded for Part 2.
- Patients who are unable to swallow oral medications.
- Patients who have gastrointestinal illnesses that may affect the absorption of oral medications.
- Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or patients who have received transplantation including patients with previous allogeneic bone marrow transplant.
- Patients known to have a history of alcoholism or drug abuse.
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
United States4 sites
- Completed
Mary Crowley Cancer Research Centers
Dallas, Texas, 75251
- Completed
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, 29605
- Completed
Hackensack University Medical Center PARTNER
Hackensack, New Jersey, 07601
- Completed
Mount Sinai
New York, New York, 10029
Australia2 sites
- Completed
Blacktown Hospital
Blacktown, New South Wales, 2148
- Completed
Linear Clinical Research Limited
Nedlands, 6009
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation and Dose-expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of the ATR Inhibitor IMP9064 Monotherapy and in Combination With PARP Inhibitor Senaparib in Patients With Advanced Solid Tumors
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
Read the detailed description
IMP9064 is an investigational therapeutic protein that may prevent repair of DNA damage in tumor cell. IMP9064 acts as inhibitor (blocker)of the proteins ataxia-telangiectasia and Rad3-related kinase (ATR) which are important in cancer cell DNA repair. If cancer cells cannot repair damage to their DNA, then there is a high possibility that cancer cells will not survive.
- Conditions
- Solid Tumor, Advanced Solid Tumor
- Being tested
- IMP9064
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP9064Drug
IMP9064 Monotherapy administered for 21 days
| Study group | Role | What they receive |
|---|---|---|
| IMP9064 Monotherapy | Experimental | Dose-escalation IMP9064 administered orally on empty stomach once/twice daily Receives: Drug: IMP9064 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 11 months
To determine the Maximum Tolerable Dose
Maximum Tolerable Dose (if any)/Recommended Phase 2 Dose of IMP9064 monotherapy
Measured: 11 months
Secondary outcomes (8)
To determine Maximum concentration (Cmax)
The plasma concentration data of IMP9064 from this study will be analyzed using a non-linear mixed effects modeling (NONMEM)
Measured: 11 months
To determine area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
The plasma concentration data of IMP9064 from this study will be analyzed using a non-linear mixed effects modeling (NONMEM)
Measured: 11 months
To assess Overall response rate (ORR)
Anti-tumor activity of IMP9064 monotherapy assessed as Overall response rate (ORR) according to RECIST version 1.1 in AST patients
Measured: 11 months
To assess Disease control rate (DCR)
Anti-tumor activity of IMP9064 monotherapy assessed as Disease control rate (DCR) according to RECIST version 1.1 in AST patients
Measured: 11 months
To assess Duration of response(DOR)
Anti-tumor activity of IMP9064 monotherapy assessed as Duration of response(DOR) according to RECIST version 1.1 in AST patients
Measured: 11 months
To assess Progression free survival(PFS)
Anti-tumor activity of IMP9064 monotherapy assessed as Progression free survival(PFS) according to RECIST version 1.1 in AST patients
Measured: 11 months
To assess Overall survival(OS)
Anti-tumor activity of IMP9064 monotherapy assessed as Overall survival(OS) according to RECIST version 1.1 in AST patients
Measured: 11 months
To assess QT interval
To assess correlation between plasma concentrations of IMP9064 and QT interval
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start11 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Impact Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269316
- Sponsor's protocol ID
- IMP9064-101
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation and Dose-expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of the ATR Inhibitor IMP9064 Monotherapy and in Combination With PARP Inhibitor Senaparib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05269316
- Acronym / sponsor ID
- IMP9064-101
- Conditions
- Solid Tumor, Advanced Solid Tumor
- Keywords
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Impact Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
IMP9064 is an investigational therapeutic protein that may prevent repair of DNA damage in tumor cell. IMP9064 acts as inhibitor (blocker)of the proteins ataxia-telangiectasia and Rad3-related kinase (ATR) which are important in cancer cell DNA repair. If cancer cells cannot repair damage to their DNA, then there is a high possibility that cancer cells will not survive.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMP9064 Monotherapy | Experimental | Drug: IMP9064Dose-escalation IMP9064 administered orally on empty stomach once/twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (29 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMP9064IMP9064 Monotherapy administered for 21 days | Drug | IMP9064 Monotherapy |
Primary outcome
Incidence of adverse events (Safety and Tolerability)
Time frame: 11 months
Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)
To determine the Maximum Tolerable Dose
Time frame: 11 months
Maximum Tolerable Dose (if any)/Recommended Phase 2 Dose of IMP9064 monotherapy
8 secondary outcomes
To determine Maximum concentration (Cmax)
Time frame: 11 months
To determine area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
Time frame: 11 months
To assess Overall response rate (ORR)
Time frame: 11 months
To assess Disease control rate (DCR)
Time frame: 11 months
To assess Duration of response(DOR)
Time frame: 11 months
To assess Progression free survival(PFS)
Time frame: 11 months
To assess Overall survival(OS)
Time frame: 11 months
To assess QT interval
Time frame: 11 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMP9064 in people with Solid Tumor and Advanced Solid Tumor, run by Impact Therapeutics, Inc. at 8 sites in 4 countries.
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 13 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia, China, Taiwan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangna Chen (+86-021-68411121, xiangna.chen@impacttherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (Safety and Tolerability) (time frame: 11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.