Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients with Advanced Cancer

Active:	Yes
Cancer Type:	Breast Cancer Ovarian Cancer	NCT ID:	NCT05735080
Trial Phases:	Phase I Phase II	Protocol IDs:	INX-315-01 (primary) NCI-2023-04176
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Incyclix Bio
NCI Full Details:	http://clinicaltrials.gov/show/NCT05735080

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.

Objectives

Study INX-315-01 is a first-in-human, Phase 1/2, open-label, dose escalation and
dose-expansion study to evaluate the safety, PK, and preliminary antitumor activity of
INX-315 in patients with advanced/metastatic cancers. The study will be conducted in 3
parts: Part A (dose escalation) and Part B (ovarian cancer dose expansion) and Part C
(breast cancer dose escalation lead-in and expansion).

Part A is the dose-escalation portion of the study to evaluate the safety, tolerability,
and PK of INX-315 monotherapy. Dosing decisions will be guided using a Bayesian optimal
interval (BOIN) design. Up to 60 patients with recurrent advanced/metastatic cancer,
including patients with HR+/HER2- breast cancer who progressed on a prior CDK4/6i
regimen, and solid tumors, including ovarian cancer with known amplification of CCNE1 are
planned to be enrolled in Part A.

Dose-limiting toxicities (DLTs) will be assessed during the first treatment cycle, i.e.,
the first 28 days of treatment (the DLT period). Patients who are evaluable for DLT
assessment are those patients who are enrolled, received =80% of the planned study drug
doses and all study visits during the DLT assessment period, and complete the 28-day DLT
period.

Additionally, Part A will have two cohorts that will include INX-315 plus fulvestrant in
HR+/HER2- patients who have have had prior treatment with CDK4/6i.

Part B will expand at least two dose levels determined by the SMC. Part B will enroll
patients with platinum-refractory or platinum-resistant advanced/metastatic ovarian
cancer patients with CCNE1 amplifications. Part B will open for enrollment once the SMC
has selected the dose levels to be evaluated from the Part A portion of the study. Part A
patients cannot re-join or continue the study in Part B. Approximately 30 patients will
be equally randomized to receive one of the dose levels of INX-315.

Part C will be an expansion cohort, patients with ER+/HER2- breast cancer will be
enrolled in this cohort.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.