Clinical trial NCT03894540: Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours
Official title: A Phase I, Open Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumour Activity of IPN60090 as Single Agent and in Combination in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the protocol is to determine safety, tolerability, recommended dose (RD), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090 as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part C) in patients with advanced solid tumours and to evaluate food effect (Part D).


Eligibility criteria: Inclusion Criteria:

* Male or female patients ≥18 years of age
* Patients with solid tumours who have received at least one line of therapy for advanced disease
* Measurable or non-measurable evaluable disease per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1
* Standard of care and/or any investigational therapies must have been completed at least 3 weeks prior to treatment

Exclusion Criteria:

* Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder
* Known primary central malignancy or symptomatic central nervous system metastasis
* Major surgical intervention within 28 days before study drug administration
* Significant acute or chronic infections

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) in Part A
timeFrame: TEAEs were to be collected from the start of the first dose of IPN60090 (Cycle 1 Day 1) up to 30 days after the date of the decision to permanently discontinue study treatment, assessed until data cut-off for study termination (maximum of 219 days).
measure: Number of Participants With Dose-Limiting Toxicities (DLT) in Cycle 1 of Part A
timeFrame: Up to Cycle 1 Day 21 of Part A
measure: Recommended Dose of IPN60090 in Part A
timeFrame: Up to Cycle 1 Day 21 of Part A
Secondary outcomes:
measure: Best Overall Response (BOR) in Part A
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).
measure: Objective Response Rate (ORR) in Part A
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).
measure: Disease Control Rate (DCR) in Part A
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).
measure: Mean Progression Free Survival (PFS) in Part A
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).
measure: Mean Overall Survival (OS) in Part A
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study drug), every 6 weeks +/-1 week for first 24 weeks, then every 12 weeks +/-2 weeks thereafter. Up to data cut-off for study termination (maximum of 247 days).
measure: Mean Best Percent Change From Baseline in the Sum of Diameters of the Target Lesions at Minimum Post-Baseline in Part A
timeFrame: Baseline (within 28 days before start of study drug) and post-baseline, up to data cut-off for study termination (maximum of 247 days).
measure: Maximum Observed Concentration (Cmax) of IPN60090 in Part A
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 14 in Part A
measure: Time to Reach Maximum Observed Concentration (Tmax) of IPN60090 in Part A
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 14 in Part A
measure: Trough Plasma Concentration (Ctrough) of IPN60090 in Part A
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 14 in Part A
measure: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IPN60090 in Part A
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 14 in Part A
measure: Apparent Elimination Half-Life (T1/2) of IPN60090 in Part A
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 in Part A
measure: Apparent Total Body Clearance (CL/F) of IPN60090 in Part A
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 in Part A
measure: Apparent Volume of Distribution (Vz/F) of IPN60090 in Part A
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 in Part A
measure: Target Engagement in Part A
timeFrame: At 2 and 12 hours postdose on Cycle 1 Day 1; predose, 2 and 12 hours postdose on Cycle 1 Day 14; and predose, 2 and 2-4 hours postdose on Cycle 1 Day 15 in Part A
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: