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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:April 2019
End Date:October 10, 2021
Contact:Ipsen Recruitment Enquiries
Email:clinical.trials@ipsen.com

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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.


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
We found this trial at
1
site
Houston, Texas 77030
?
mi
from
Houston, TX
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