Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

A Phase I/Ib, Open-label, Multi-center Dose-escalation and Dose-expansion Study of the Safety and Tolerability of Intra-tumorally Administered LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

ClinicalTrials.gov Identifier: NCT03301896

Novartis Reference Number: CLHC165X2101

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this trial is to explore the clinical utility of two investigational agents in patients with advanced cancer.

This is a multi-center, open-label Phase I/Ib study. The study consists of four dose escalation parts and two dose expansion parts testing LHC165 as a single agent or LHC165 in combination with PDR001. The dose escalation parts will estimate the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) and test two different dosing schedules for LHC165.

The dose expansion parts of the study will use the MTD/RDE for each the LHC165 single agent and in combination with PDR001, determined in the respective dose escalation parts to assess the activity, safety and tolerability of LHC165 as a single agent or LHC165 in combination with PDR001 in patients with specific types of solid tumors.

Approximately 206 adult patients with advanced solid tumors will be enrolled.

Condition 
Solid Tumors
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
80 participants
Start date 
Jan 31, 2018
Completion date 
Mar 21, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LHC165
LHC165 intratumoral injection
Biological
PDR001
PDR001 infusion

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be obtained prior to any procedures unless considered standard of care.
Adult men and women (≥ 18 years of age) with histologically confirmed diagnosis of metastatic and/or advanced solid tumors not amenable to curative treatment by surgery.
Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Dose escalation: Patients with accessible tumors and with measurable disease as determined by RECIST 1.1 and have progressed despite standard treatment or are intolerant of standard treatment, or for whom no standard treatment exists.
Dose expansion: Patients with advanced/metastatic solid tumors: HNSCC, melanoma, accessible tumors and visceral tumors (LHC165 combination with PDR001 only). Patients must have measurable disease as determined by RECIST 1.1 and have progressed despite standard treatment or are intolerant to standard treatment, or for whom no standard treatment exists• Patients must have at least two sites of disease amenable to biopsy.
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

Presence of symptomatic or uncontrolled central nervous system (CNS) metastases requiring local CNS-directed treatment.
Patients diagnosed with hematological malignancies.
Patients with prior stem cell transplants.
Patients previously treated with TLR-7/8 agonist treatment.
History of primary immunodeficiency
Patients who discontinued prior anti-PD-1/PD-L1 therapy due to an anti-PD-1/PD-L1-related toxicity.
Malignant disease, other than that being treated in this study

Study Locations

United States
UCLA
Recruiting
Los Angeles, 90095
California
United States
MD Anderson Cancer Center
Recruiting
Houston, 77030
Texas
United States
Belgium
Novartis Investigative Site
Completed
Wilrijk, 2610
-
Belgium
Italy
Novartis Investigative Site
Recruiting
Milano, 20141
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104 0045
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]