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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06253130




Registration number
NCT06253130
Ethics application status
Date submitted
27/01/2024
Date registered
12/02/2024
Date last updated
22/04/2024

Titles & IDs
Public title
A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
Scientific title
A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
2023-509230-19
Secondary ID [2] 0 0
EIK1003-001 (IMP1734-101)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMP1734

Experimental: Cohort 1 - IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial.


Treatment: Drugs: IMP1734
PARP1 selective inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events, treatment emergent adverse events or serious adverse events
Timepoint [1] 0 0
Consent to 30 + 7 days post last dose of IMP1734
Primary outcome [2] 0 0
Maxim Tolerated Dose or Recommended Dose for Expansion
Timepoint [2] 0 0
DLT period is from the first dose of the study drug until the last day of the first cycle
Secondary outcome [1] 0 0
Pharmacokinetic parameters of IMP1734
Timepoint [1] 0 0
Through study completion, up to 3 years
Secondary outcome [2] 0 0
Pharmacokinetic parameters of IMP1734
Timepoint [2] 0 0
Through study completion, up to 3 years
Secondary outcome [3] 0 0
Pharmacokinetic parameters of IMP1734
Timepoint [3] 0 0
Through study completion, up to 3 years
Secondary outcome [4] 0 0
Overall Response Rate
Timepoint [4] 0 0
Through study completion, up to 3 years

Eligibility
Key inclusion criteria
Key Inclusion Criteria

- Breast cancer; must have received at least one prior chemotherapy in
neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+,

- HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer;
must have received at least one prior platinum-based chemotherapy for advanced disease

- mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane
chemotherapy

- Age = 18 years at the time of informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status =1

- Adequate organ function

- Life expectancy = 12 weeks

- Should have evaluable disease as defined by RECIST1.1 and/or CA125 or PSA

- Female subjects of childbearing potential and male subjects must agree to use an
effective method of contraception from study entry up to 6 months after the last dose
of IMP1734

- deleterious or suspected deleterious germline or somatic mutations of select HHR genes

- up to 1 prior line of PARP inhibitor containing treatment

Key
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any investigational or approved anti-cancer therapies administered within 28 days/
before the first dose of IMP1734

- Have received prior PARP1 selective inhibitors

- Mean resting QTcF > 470 ms or QTcF < 340 ms

- Active or untreated central nervous system (CNS) metastases and/or carcinomatous
meningitis.

- Infections

- An active hepatitis B/C infection

- Any known predisposition to bleeding

- Unable to swallow oral medications OR have malabsorption syndrome or any other
uncontrolled gastrointestinal condition that might impair the bioavailability

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [2] 0 0
Mater Cancer Care Centre, Mater Misericordiae Limited - South Brisbane
Recruitment hospital [3] 0 0
Gold Coast Private Hospital - Southport
Recruitment hospital [4] 0 0
Macquarie University - Sydney
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Peninsula and south eastern haematology and oncology group - Frankston
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4125 - Southport
Recruitment postcode(s) [4] 0 0
2109 - Sydney
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eikon Therapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Impact Therapeutics, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the preliminary efficacy of IMP1734 in patients with recurrent
advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate
cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous
recombination repair (HRR) genes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06253130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Viola Chen, MD
Address 0 0
Eikon Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Caroline Taromino
Address 0 0
Country 0 0
Phone 0 0
(341) 777-0566
Fax 0 0
Email 0 0
parpitrial@eikontx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06253130