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Trial of INI-4001 in Patients With Advanced Solid Tumours
Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors.
Study details:
This is a Phase Ia/Ib, open-label, dose-escalation, and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion). Phase Ia will initially seek to establish the MTD of INI-4001 administered as a monotherapy.
Following identification of the MTD, any dose level at or below the MTD may be further expanded to further explore the safety, PK, PD, and preliminary efficacy of INI-4001 alone and in combination with a complementary therapy (Phase Ib). Following cessation of INI-4001, patients will be requested to participate in long-term follow-up to assess overall survival. This long-term follow-up will continue for each patient until at least 1 year after their last dose of INI-4001, or until otherwise advised by the Sponsor.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-29
Primary completion: 2024-08-01
Study completion finish: 2026-04-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06302426
Intervention or treatment
DRUG: INI-4001
COMBINATION_PRODUCT: Nivolumab
COMBINATION_PRODUCT: Pembrolizumab
COMBINATION_PRODUCT: Cemiplimab
COMBINATION_PRODUCT: Avelumab
COMBINATION_PRODUCT: Atezolizumab
COMBINATION_PRODUCT: Durvalumab
Conditions
- • Advanced Solid Tumor
Find a site
Closest Location:
The Border Cancer Hospital
Research sites nearby
Select from list below to view details:
The Border Cancer Hospital
Albury, New South Wales, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
| DRUG: INI-4001
|
EXPERIMENTAL: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
| DRUG: INI-4001
|
EXPERIMENTAL: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
| DRUG: INI-4001
|
EXPERIMENTAL: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
| DRUG: INI-4001
|
EXPERIMENTAL: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
| DRUG: INI-4001
|
EXPERIMENTAL: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
| DRUG: INI-4001
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy | Graded using a 5 point scale | Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses | Graded using a 5 point scale | Assessed at Screening, then daily from Cycle 1 Day 1 through to 30 days post last dose of INI-4001 |
Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses | Graded using a 5 point scale | Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21 |
Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses | Pulse rate \[PR\], systolic and diastolic blood pressure \[BP\], temperature, respiratory rate.\[RR\] and oxygen saturation. Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine,respiratory rate is measured manually via 60- second count.\[RR\] and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs. | Assessed at Screening, then Cycle 1 Day 1 through to 30 days post last dose of INI-4001 |
Number of Participants with a Change from baseline in body weight after multiple ascending doses | Weight will be measured utilising scales | Assessed at Screening then pre-dose on Day 1 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first |
Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses | Haematology - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges. | Assessed at Screening, then Day 1 and Day 15 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first |
Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses | Serum Chemistry - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges. | Assessed at Screening, then Day 1 and Day 15 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first |
Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses | Urinalysis - urine samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges. | Assessed at Screening, then Day 1 and Day 15 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first |
Change from baseline in measurements of HR in beats per minute after multiple ascending doses | 12-lead ECG parameters include the measurements of HR in beats per minute. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints. | Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001 |
Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses | 12-lead ECG parameters include the measurements of PR interval. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints. | Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001 |
Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses | 12-lead ECG parameters include the . 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints. | Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001 |
Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses | 12-lead ECG parameters include the measurements of RR interval in breaths per minute. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints. | Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001 |
Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses | 12-lead ECG parameters include the measurements of QRS duration. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints. | Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001 |
Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses | 12-lead ECG parameters include the measurements of QTcF. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints. | Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001 |
Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses | Graded using a 6 point scale | Screening, then Cycle 1 & Cycle 2 (each cycle is 21 days) on Day 1, Day 8 and Day 15 and then at 7 days and 30 days post last dose of INI-4001 |
Single dose PK Parameters - maximum observed concentration (Cmax) | Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Multiple dose PK Parameters - maximum observed concentration (Cmax) | Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Single dose PK Parameters - Time to Cmax (Tmax) | Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Multiple dose PK Parameters - Time to Cmax (Tmax) | Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) | Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Single dose PK Parameters - Total amount excreted in urine (Ae) | Pharmacokinetics (PK) of INI-4001 in urine following a single dose | Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days) |
Single dose PK Parameters - Fraction excreted in the urine (Fe) | Pharmacokinetics (PK) of INI-4001 in urine following a single dose | Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days) |
Single dose PK Parameters - Renal clearance (CLr) | Pharmacokinetics (PK) of INI-4001 in urine following a single dose | Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days) |
Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) | Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Single dose PK Parameters - Area under the concentration-time curve (AUC0-t) | Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t) | Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Single dose PK Parameters - Half-life (t1/2) | Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Multiple dose PK Parameters - Half-life (t1/2) | Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Single dose PK Parameters - Clearance (Cl) | Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Multiple dose PK Parameters - Clearance (Cl) | Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Single dose PK Parameters - Volume of distribution (Vz) | Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Multiple dose PK Parameters - Volume of distribution (Vz) | Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses | Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days) |
Frequently Asked Questions
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