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

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

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).

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