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

NCT ID: NCT03301896

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2022-06-30

Brief Summary

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

Detailed Description

This was a multi-center, open-label Phase I/Ib study. The study consisted 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 estimated the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) and were planned to test two different dosing schedules for LHC165 single agent (Group A and B) and LHC165 in combination with PDR001 (Group C and D).

The dose expansion parts of the study were planned to use the MTD/RDE for each the LHC165 single agent (Group E) and LHC165 in combination with PDR001 (Group F), 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.

The study was terminated due to business reasons. Groups B, D and E were not opened for enrollment.

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LHC165 single agent

LHC165 intratumoral injection given alone

Group Type: EXPERIMENTAL

LHC165

Intervention Type: DRUG

LHC165 intratumoral injection

LHC165 in combination with PDR001

LHC165 intratumoral injection given with PDR001 infusion

Group Type: EXPERIMENTAL

LHC165

Intervention Type: DRUG

LHC165 intratumoral injection

PDR001

Intervention Type: BIOLOGICAL

PDR001 infusion

Interventions

LHC165

LHC165 intratumoral injection

Intervention Type: DRUG

PDR001

PDR001 infusion

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nehal Parikh, MD

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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

Countries

United States; Belgium; Germany; Italy; Japan; South Korea; Spain

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18030

Study Results

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1546

Plain Language Trial Summary

Other Identifiers

CLHC165X2101

Identifier Type: -

Identifier Source: org_study_id