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

Stopped early · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer. This was a multi-center, open-label Phase I/Ib study. The primary objectives of the trial were: * To characterize the safety and tolerability of intratumoral LHC165 in patients with solid tumors as a single agent and in combination with PDR001 * To determine and evaluate the maximum tolerated dose (MTD)/recommended dose (RD) for LHC165 as a single agent and in combination with PDR001

Key facts

Study ID

NCT03301896

Run by

Novartis Pharmaceuticals

People needed

45

Starts

2018-01-31

Expected to finish

2022-06-30

Last updated by the study team

2024-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCLA — Los Angeles, California, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Novartis Investigative Site — Wilrijk, Belgium
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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