Description:
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).
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
D-US-60090-001
- SECONDARY ID:
2018-003681-13
- NCT ID:
NCT03894540
Conditions
Interventions
Drug | Synonyms | Arms |
---|
IPN60090 | | IPN60090 |
pembrolizumab | | IPN60090 in combination with pembrolizumab |
paclitaxel | | IPN60090 in combination with paclitaxel |
IPN60090 single administration | | IPN60090 food effect |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
IPN60090 | Experimental | Part 1: Dose escalation of IPN60090, Part 2: Dose expansion
IPN60090 given as a Bis in Die (BID) oral dose administered up to Maximum Tolerated Dose (MTD) over a 21-day cycle | |
IPN60090 in combination with pembrolizumab | Experimental | Part 1: Dose escalation of IPN60090 in combination with pembrolizumab, Part 2: Dose expansion
IPN60090 given as a Bis in Die (BID) oral dose, starting with pharmacologically active dose identified in 1dose escalation of IPN60090 as a single agent, over a 21-day cycle in combination with 200 mg pembrolizumab given every 21 days (Day 1 of every cycle) as IV infusion | |
IPN60090 in combination with paclitaxel | Experimental | Part 1: Dose escalation of IPN60090 in combination with paclitaxel, Part 2: Dose expansion
IPN60090 given as a BID oral dose, starting with pharmacologically active dose identified in dose escalation of IPN60090 as a single agent over a 21-day cycle in combination with 175 mg/m2 or 135 mg/m2 paclitaxel given every 21 days (Day 1 of every cycle) as IV infusion | |
IPN60090 food effect | Experimental | Part 1: Food Effect of IPN60090
IPN60090 given as a single oral dose as a single agent at the recommended dose (RD) under fasting and fed conditions followed by IPN60090 given as a BID oral dose administered at the RD over a 21-day cycle. | - IPN60090 single administration
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of Dose Limiting Toxicities (DLTs) |
Time Frame: | Cycle 1 day 21 at each dose level |
Safety Issue: | |
Description: | Safety and tolerability of oral IPN60090 as a single agent (Part A) and in combination therapy with pembrolizumab (Part B) or paclitaxel (Part C), as determined by the rate of Dose Limiting Toxicities (DLTs) |
Secondary Outcome Measures
Measure: | Clinical Benefit Rate (CBR) |
Time Frame: | up to 6 months |
Safety Issue: | |
Description: | Proportion of patients with Best Overall Response (BOR) of Complete response (CR), Partial Response (PR) and Stable Disease (SD) lasting ≥12 weeks |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Ipsen |
Last Updated
February 3, 2021