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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT06253130
Ethics application status
Date submitted
27/01/2024
Date registered
12/02/2024
Date last updated
8/10/2024

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 HRR 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
Not applicable
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
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
China
State/province [12] 0 0
Chongqing
Country [13] 0 0
China
State/province [13] 0 0
Hangzhou
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Gyeonggi-Do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Namdong-gu
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul

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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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