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Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours

NCT03894540

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).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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
  • NCT ID: NCT03894540

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
IPN60090IPN60090
pembrolizumabIPN60090 in combination with pembrolizumab
paclitaxelIPN60090 in combination with paclitaxel
IPN60090 single administrationIPN60090 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

NameTypeDescriptionInterventions
IPN60090ExperimentalPart 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
IPN60090 in combination with pembrolizumabExperimentalPart 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
  • pembrolizumab
IPN60090 in combination with paclitaxelExperimentalPart 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
  • paclitaxel
IPN60090 food effectExperimentalPart 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:Recruiting
Lead Sponsor:Ipsen

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