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

Ipsen

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor

Treatments: Drug: paclitaxel; Drug: pembrolizumab; Drug: IPN60090 single administration; Drug: IPN60090

Study type: Interventional

Funder types: Industry

Identifiers

NCT03894540

D-US-60090-001

2018-003681-13 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 4 patient groups

IPN60090

Experimental group

Description:

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

Treatment:

Drug: IPN60090

IPN60090 in combination with pembrolizumab

Experimental group

Description:

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

Treatment:

Drug: IPN60090

Drug: pembrolizumab

IPN60090 in combination with paclitaxel

Experimental group

Description:

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

Treatment:

Drug: IPN60090

Drug: paclitaxel

IPN60090 food effect

Experimental group

Description:

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.

Treatment:

Drug: IPN60090 single administration