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Advanced Solid TumoursPhase 1NCT03508011

A Study of IMP4297 in Patients With Advanced Solid Tumors

A Phase 1 study testing IMP4297 in people with Advanced Solid Tumours and Breast Cancer, run by Impact Therapeutics, Inc. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
IMP4297
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesChina
Study dates
23 Aug 2017to 16 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • 18 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.

Who cannot join

  • 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.
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  • 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
  • Known clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Known human immunodeficiency virus infection
  • New York Heart Association Class II or greater congestive heart failure; history of myocardial infarction or unstable angina within 6 months prior to Day 1; history of stroke or transient ischemic attack within 6 months prior to Day 1
  • Active or untreated brain metastasis
  • Pregnant (positive pregnancy test) or lactating women
  • Male or female patients of child-producing potential unwilling to use double barrier contraception: condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (oral, injectable or parenteral), implanon, or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
  • Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
  • Inability to comply with study and follow-up procedures
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors

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.

Being tested
IMP4297
Keywords
Breast Cancer, Ovarian Cancer, Prostate Cancer, Advanced solid tumours
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMP4297Drug

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

Study groups in NCT03508011
Study groupRoleWhat they receive
IMP4297ExperimentalNot described
Receives: Drug: IMP4297

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

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

    Evaluate DLT and determine the MTD

    Measured: Within 28 days after IMP4297 administrated

Secondary outcomes (12)

  1. Area Under Curve [AUClast, AUCINF]

    Measured: Within 7 days after firstly single dose administrated

  2. Area Under Curve [AUClast, AUCINF]

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

  3. Maximum plasma concentration (Cmax)

    Measured: Within 7 days after firstly single dose administrated

  4. Maximum plasma concentration (Cmax)

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

  5. Time at which Cmax occurred (Tmax)

    Measured: Within 7 days after firstly single dose administrated

  6. Time at which Cmax occurred (Tmax)

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

  7. Trough Concentrations (Ctrough)

    Measured: Within 7 days after firstly single dose administrated

  8. Trough Concentrations (Ctrough)

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

  9. Clearance (CL/F)

    Measured: Within 7 days after firstly single dose administrated

  10. Clearance (CL/F)

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

  11. Volume of distribution (Vd/F)

    Measured: Within 7 days after firstly single dose administrated

  12. Volume of distribution (Vd/F)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start23 Aug 2017
  3. Primary completion16 Dec 2020
  4. Study completion16 Dec 2020

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03508011
Sponsor's protocol ID
IMP4297-2016-CN01
Status last verified
Mar 2021
First submitted
8 Jan 2018
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37338150

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMP4297 in people with Advanced Solid Tumours and Breast Cancer, run by Impact Therapeutics, Inc. at 2 sites in China.

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 6 inclusion and 24 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: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The AEs (adverse event) of single and multiple doses of IMP4297 administered to participants with advanced solid tumors. (time frame: Each visit after IMP4297 administrated (through study completion, an average of 10 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?

On the ClinicalTrials.gov record for NCT03508011, which also lists 1 linked publication.

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 30 Mar 2021.

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