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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05735080




Registration number
NCT05735080
Ethics application status
Date submitted
9/02/2023
Date registered
21/02/2023

Titles & IDs
Public title
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
Scientific title
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer
Secondary ID [1] 0 0
INX-315-01
Universal Trial Number (UTN)
Trial acronym
INX-315-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Cancer Metastatic 0 0
Hormone Receptor Positive Tumor 0 0
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast 0 0
Ovarian Cancer 0 0
CCNE1 Amplification 0 0
Solid Tumor 0 0
Advanced Cancer 0 0
Metastatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INX-315

Experimental: Part A: Dose Escalation - Multiple doses of INX-315 monotherapy, oral administration

Experimental: Part B: Ovarian Dose Expansion - INX-315 monotherapy, oral administration

Experimental: Part C: ER+/HER2- BC Dose Expansion - INX-315 in combination with CDK4/6i and endocrine therapy, oral administration


Treatment: Drugs: INX-315
Oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities
Timepoint [1] 0 0
Up to 12 months
Primary outcome [2] 0 0
Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase
Timepoint [3] 0 0
Up to 12 months
Primary outcome [4] 0 0
Part B: Overall response rate (ORR)
Timepoint [4] 0 0
Up to 36 months
Primary outcome [5] 0 0
Part B: Selection of Recommended Phase 2 Dose (RP2D)
Timepoint [5] 0 0
Up to 36 months
Secondary outcome [1] 0 0
Part A and B: Characterize the maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Cycle 1 Day 1 and Day 15
Secondary outcome [2] 0 0
Part A and B: Characterize the time to maximum plasma concentration (Tmax)
Timepoint [2] 0 0
Cycle 1 Day 1 and Day 15
Secondary outcome [3] 0 0
Part A and B: Characterize the Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24h)
Timepoint [3] 0 0
Cycle 1 Day 1 and Day 15
Secondary outcome [4] 0 0
Part A and B: Characterize the terminal half-life (t1/2)
Timepoint [4] 0 0
Cycle 1 Day 1 and Day 15
Secondary outcome [5] 0 0
Part A and B: Characterize the oral clearance (CL/F)
Timepoint [5] 0 0
Cycle 1 Day 1 and Day 15
Secondary outcome [6] 0 0
Part A: Overall response rate (ORR)
Timepoint [6] 0 0
Up to 36 months
Secondary outcome [7] 0 0
Part A and B: Disease control rate (DCR)
Timepoint [7] 0 0
Up to 36 months
Secondary outcome [8] 0 0
Part A and B: Progression free survival (PFS)
Timepoint [8] 0 0
Up to 36 months
Secondary outcome [9] 0 0
Part A and B: Duration of response (DOR)
Timepoint [9] 0 0
Up to 36 months
Secondary outcome [10] 0 0
Part A and B: Time to progression (TTP)
Timepoint [10] 0 0
Up to 36 months
Secondary outcome [11] 0 0
Part A and B: Overall survival (OS)
Timepoint [11] 0 0
Up to 36 months

Eligibility
Key inclusion criteria
1. Advanced unresectable or metastatic ER+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor
2. Advanced/ metastatic platinum-resistant or platinum-refractory epithelial ovarian cancer (including fallopian tube cancer/primary peritoneal cancer) CCNE1 amplified tumors that progressed after standard systemic therapy
3. Advanced or metastatic solid tumor with known amplification of CCNE1that has progressed after standard therapy, been intolerant to or is ineligible for standard therapy
4. At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated
5. ECOG performance status score of 0 or 1.
6. Adequate organ function as demonstrated by the following laboratory values:

1. Hemoglobin = 9.0 g/dL
2. Absolute neutrophil count (ANC) = 1.5 × 109/L
3. Platelet count = 100 × 109/L
4. Estimated glomerular filtration rate (eGFR) of =60 mL/min
5. Total bilirubin = 1.5 × ULN; AST and ALT = 2.5 × ULN; = 5 × ULN in the presence of liver metastases
7. Negative pregnancy test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have received previous therapy with a CDK2/4/6 inhibitor, CDK2 inhibitor, PKMYT1 inhibitor, or WEE1 inhibitor.
2. Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires corticosteroids (within 4 weeks of enrollment) to control the CNS disease.
3. Have known intracranial hemorrhage and/or bleeding diatheses.
4. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
5. Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.
6. Resting QTcF > 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
7. Uncontrolled, cardiovascular disease (including hypertension) with or without medication
8. History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for = 3 years.
9. Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms and a positive test result).
10. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.
11. Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).
12. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
13. Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.
14. Systemic anti-cancer therapy within 28 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug
15. Prior irradiation to >25% of the bone marrow
16. Previous high-dose chemotherapy requiring prior stem cell transplant
17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.
18. Known or suspected hypersensitivity to active ingredient/excipients in INX-315.
19. Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
81
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Parkville
Recruitment hospital [2] 0 0
Mater Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyclix Bio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Director
Address 0 0
Country 0 0
Phone 0 0
1-919-328-0003
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Data will be shared at the completion of the study, expected release date will be in 2026.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05735080