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LHC165 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial found that LHC165 was well tolerated as a single agent and in combination with PDR001, with a maximum tolerated dose of 300 mg/m2. The most common adverse events were fatigue, nausea, and vomiting.

Eligible Conditions
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Escalation and Expansion: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), including changes in laboratory parameters, vital signs, electrocardiograms (ECGs)
Escalation: Incidence of Dose-limiting Toxicities (DLTs) in Cycle 1
Secondary outcome measures
Best Overall Response (BOR) per RECIST 1.1 and iRECIST
Change from baseline in tumor infiltrating lymphocytes in injected and distal tumor specimens
Disease Control Rate (DCR) per RECIST 1.1 and iRECIST
+13 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
83%
Aspartate aminotransferase increased
67%
Alanine aminotransferase increased
67%
Diarrhoea
50%
Pyrexia
50%
Abdominal distension
50%
Hyperphosphataemia
33%
Blood bilirubin increased
33%
Oedema peripheral
33%
Anaemia
33%
Abdominal pain
33%
Nausea
33%
Fatigue
33%
Neutrophil count decreased
33%
Pruritus
33%
Rash
17%
Epistaxis
17%
Productive cough
17%
Liver carcinoma ruptured
17%
Tinea cruris
17%
Dysgeusia
17%
Oesophageal varices haemorrhage
17%
Hyperglycaemia
17%
Blood creatinine increased
17%
Hypokalaemia
17%
Vomiting
17%
Rash pustular
17%
Sinusitis
17%
Blood creatine phosphokinase increased
17%
Weight decreased
17%
Gamma-glutamyltransferase increased
17%
Platelet count decreased
17%
Arthralgia
17%
Myalgia
17%
Insomnia
17%
Dyspnoea exertional
17%
Hot flush
17%
Headache
17%
Cough
17%
Pneumonitis
17%
Hyperthyroidism
17%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: FGF401 120 mg + PDR001 300 mg
All Patients of Combination Dose
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted

Trial Design

2Treatment groups
Experimental Treatment
Group I: LHC165 single agentExperimental Treatment1 Intervention
LHC165 intratumoral injection given alone
Group II: LHC165 in combination with PDR001Experimental Treatment2 Interventions
LHC165 intratumoral injection given with PDR001 infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2700

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,852 Previous Clinical Trials
4,197,700 Total Patients Enrolled
Nehal Parikh, MDStudy DirectorNovartis Pharmaceuticals
1 Previous Clinical Trials
8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025