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

• Status: Terminated
• Trial end date: 2020-12-21
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Pembrolizumab

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