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Advanced Solid TumoursPhase 1NCT03507543

The Safety and Pharmacokinetics 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 3 sites in Australia.

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 1, First-In-Human, open label study, trialing a new PARP (poly-ADP ribose polymerase) inhibitor medication IMP4297 in participants with advanced solid tumour. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMP4297
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesAustralia
Study dates
3 Feb 2017to 17 Mar 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • Age greater than or equal to 18 years
  • Histologically or cytologically documented, incurable, advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy
  • Evaluable or measurable disease per RECIST 1.1
  • ECOG 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.

Who cannot join

  • Inadequate haematologic and organ function, defined by the following (haematologic parameters must be assessed greater than or equal to 14 days after a prior treatment, if any):
  • Absolute neutrophil count <1500 cells/uL
  • Haemoglobin <9 g/dL
  • Total bilirubin >1.5 x the ULN, with documented liver metastases total bilirubin >3 x the ULN .
  • AST and/or ALT >2.5 x the ULN, with documented liver metastases AST and/or ALT levels > 5 x the ULN.
  • Serum creatinine > 1.5 x the ULN, or creatinine clearance < 50 mL/min based on a documented 24-hour urine collection.
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  • International normalized ratio (INR) > 1.5 x the ULN or activated partial thromboplastin time (aPTT) >1.5 x 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 CTCAE Grade less than or equal to 1, except for alopecia
  • 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 (NYHA) 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 (IUD), 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

3 sites in 1 country.

Australia3 sites

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • St George Private Hospital

    Kogarah, New South Wales

  • Nucleus Network

    Melbourne, Victoria, 3004

Other trials in Australia

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 1, First-In-Human, open label study, trialing a new PARP (poly-ADP ribose polymerase) inhibitor medication IMP4297 in participants with advanced solid tumour.

Read the detailed description

This is a phase 1, First-In-Human, open label study, trialing a new PARP inhibitor medication IMP4297 in participants with advanced solid tumour.

Six different dosage cohorts 2mg, 6mg, 10mg, 20mg, 30mg and 40mg will be used to establish the maximum tolerated dosage. First participant in each dosing cohort will be administered one dose of IMP4297 capsule, followed by a wash out period of at least 5 half-lives or 7 days. Safety information such as pathology result or adverse events experienced will be collected following first dosing. This will be reviewed by the a safety review committee that is made up of the Principal Investigator, Medical Monitor, the study Sponsor and a representative from the Clinical Research Organisation, which will collectively determine if it is safe to proceed to continue with the next scheduled dosing cohort. Participant will proceed with repeat once daily dose at the same dose level for 3 weeks. Each repeat dose treatment cycle will be composed of 3 weeks (Day 1 to Day 21). IMP4297 will be administered by participants at home. Participants will be instructed to bring unused IMP4297 capsules with them to each visit for trial staff to review and confirm amount of IMP4297capsules taken since the last visit. The administration of the IMP4297 capsules will be recorded. Study drug compliance will be assessed using these records in conjunction with a count of unused IMP4297 capsules. Participants who are benefiting from IMP4297 may have the possibility of treatment beyond 1 year at the investigator's discretion. Participants who experience disease progression or unacceptable side effects, are not compliant with study protocol or in the opinion of the investigator will have IMP4297 administration discontinued and study participation will be terminated.

Being tested
IMP4297
Keywords
Breast Cancer, Ovarian Cancer, Prostate Cancer, Advanced solid tumours, primary peritoneal Cancer
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 NCT03507543
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 and AUCtau]

    Measured: Within 7 days after firstly single dose administrated

  2. Area Under Curve [AUClast, AUCINF and AUCtau]

    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 start3 Feb 2017
  3. Primary completion24 Sep 2020
  4. Study completion17 Mar 2021

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03507543
Sponsor's protocol ID
IMP4297-2016-AU01
Status last verified
Mar 2021
First submitted
8 Jan 2018
Last updated
30 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gao B, Voskoboynik M, Cooper A, Wilkinson K, Hoon S, Hsieh CY, Cai S, Tian YE, Bao J, Ma N, Wang C, Zhang M, Li B, Guo M, Zhou R, Wang X, Xu C, de Souza P. A phase 1 dose-escalation study of the poly(ADP-ribose) polymerase inhibitor senaparib in Australian patients with advanced solid tumors. Cancer. 2023 Apr 1;129(7):1041-1050. doi: 10.1002/cncr.34662. Epub 2023 Jan 31.

    PubMed 36718624

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 3 sites in Australia.

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 22 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 3 sites in Australia. 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 NCT03507543, 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; AzTrials last refreshed its copy on 8 Nov 2026.

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