Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05735080
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-02-09
Brief Title:
Open-Label Study to Evaluate the Safety Tolerability PK and Efficacy of INX-315 in Patients with Advanced Cancer
Sponsor:
Incyclix Bio
Organization:
Incyclix Bio
Study Overview
Official Title:
A Phase 12 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of INX-315 in Patients with Advanced Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INX-315-01
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 advancedmetastatic cancer including hormone receptor positive HRHuman Epidermal Growth Factor Receptor 2 Negative HER2- breast cancer who progressed on a prior cyclin-dependent kinase 46 inhibitor CDK46i 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 CDK46i and selective estrogen receptor degrader SERD in HRHER2- breast cancer patients who have progressed on prior CDK46i regimen
Detailed Description:
Study INX-315-01 is a first-in-human Phase 12 open-label dose escalation and dose-expansion study to evaluate the safety PK and preliminary antitumor activity of INX-315 in patients with advancedmetastatic 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 advancedmetastatic cancer including patients with HRHER2- breast cancer who progressed on a prior CDK46i 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 ie 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 HRHER2- patients who have have had prior treatment with CDK46i
Part B will expand at least two dose levels determined by the SMC Part B will enroll patients with platinum-refractory or platinum-resistant advancedmetastatic 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 ERHER2- breast cancer will be enrolled in this cohort
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 advancedmetastatic cancer including patients with HRHER2- breast cancer who progressed on a prior CDK46i 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 ie 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 HRHER2- patients who have have had prior treatment with CDK46i
Part B will expand at least two dose levels determined by the SMC Part B will enroll patients with platinum-refractory or platinum-resistant advancedmetastatic 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 ERHER2- breast cancer will be enrolled in this cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None