ANZCTR - Registration

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05735080

Registration number

NCT05735080

Ethics application status

Date submitted

9/02/2023

Date registered

21/02/2023

Date last updated

22/05/2024

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]

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

Breast Cancer Metastatic

Hormone Receptor Positive Tumor

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Ovarian Cancer

CCNE1 Amplification

Solid Tumor

Advanced Cancer

Metastatic Cancer

Condition category

Condition code

Cancer

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities

Timepoint [1]

Up to 12 months

Primary outcome [2]

Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1

Timepoint [2]

28 days

Primary outcome [3]

Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase

Timepoint [3]

Up to 12 months

Primary outcome [4]

Part B: Overall response rate (ORR)

Timepoint [4]

Up to 36 months

Primary outcome [5]

Part B: Selection of Recommended Phase 2 Dose (RP2D)

Timepoint [5]

Up to 36 months

Secondary outcome [1]

Part A and B: Characterize the maximum plasma concentration (Cmax)

Timepoint [1]

Cycle 1 Day 1 and Day 15

Secondary outcome [2]

Part A and B: Characterize the time to maximum plasma concentration (Tmax)

Timepoint [2]

Cycle 1 Day 1 and Day 15

Secondary outcome [3]

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]

Cycle 1 Day 1 and Day 15

Secondary outcome [4]

Part A and B: Characterize the terminal half-life (t1/2)

Timepoint [4]

Cycle 1 Day 1 and Day 15

Secondary outcome [5]

Part A and B: Characterize the oral clearance (CL/F)

Timepoint [5]

Cycle 1 Day 1 and Day 15

Secondary outcome [6]

Part A: Overall response rate (ORR)

Timepoint [6]

Up to 36 months

Secondary outcome [7]

Part A and B: Disease control rate (DCR)

Timepoint [7]

Up to 36 months

Secondary outcome [8]

Part A and B: Progression free survival (PFS)

Timepoint [8]

Up to 36 months

Secondary outcome [9]

Part A and B: Duration of response (DOR)

Timepoint [9]

Up to 36 months

Secondary outcome [10]

Part A and B: Time to progression (TTP)

Timepoint [10]

Up to 36 months

Secondary outcome [11]

Part A and B: Overall survival (OS)

Timepoint [11]

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?

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/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

28/03/2023

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/06/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Peter MacCallum Cancer Center - Parkville

Recruitment hospital [2]

Mater Hospital - South Brisbane

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

4101 - South Brisbane

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Georgia

Country [2]

United States of America

State/province [2]

Massachusetts

Country [3]

United States of America

State/province [3]

North Carolina

Country [4]

United States of America

State/province [4]

Ohio

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Incyclix Bio

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin
dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is
designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary
antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer,
including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative
(HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor
(CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care
treatment. This study will evaluate approximately 6 dose levels of daily INX-315 in Part A,
at least two dose levels will be evaluated in Part B to identify the Recommended Phase 2 Dose
(RP2D) in patients with ovarian cancer, and Part C will evaluate combination treatment of
INX-315 plus a CDK4/6i and selective estrogen receptor degrader (SERD) in HR+/HER2- breast
cancer patients who have progressed on prior CDK4/6i regimen.

Trial website

https://clinicaltrials.gov/ct2/show/NCT05735080

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Clinical Director

Address

Country

Phone

1-919-328-0003

Fax

clinicalinfo@incyclixbio.com

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05735080

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05735080