LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

April 30, 2018

Study Completion Date

August 31, 2018

Conditions
CancerMelanomaBreast CancerHead and Neck CancerLymphomaTriple-Negative Breast Cancer
Interventions
DRUG

LTX-315 consecutive lesions

"Dose escalation:~Cohort 1: 2 mg twice per day (4 mg) Cohort 2: 3 mg twice per day (6 mg) Cohort 3: 4 mg twice per day (8 mg)"

DRUG

LTX-315

"Dose escalation:~Cohort 1: 3 mg per injection Cohort 2: 4 mg per injection Cohort 3: 5 mg per injection"

DRUG

LTX-315 + ipilimumab

Cohort 1: 3 mg per injection + 3 mg/kg ipilumumab Cohort 2: 4 mg per injection + 3 mg/kg ipilumumab Cohort 3: 5 mg per injection + 3 mg/kg ipilumumab

DRUG

LTX-315 + pembrolizumab

Cohort 1: 3 mg per injection + 200 mg pembrolizumab Cohort 2: 4 mg per injection + 200 mg pembrolizumab Cohort 3: 5 mg per injection + 200 mg pembrolizumab

Trial Locations (14)

1000

Jules Bordet Institute, Brussels

1200

Cliniques Universitaires St-Luc, Service d'oncologie médicale, Brussels

5021

Haukeland University Hospital, Bergen

20141

Intotuto Europeo di Oncologia (IEO), Milan

San Raffaele Hospital, Milan

35128

Instituto Oncologico Venneto (IOV), Padua

75248

Institut Curie, Paris

80131

Intituto Nazionale dei Tumori, Napoli

94805

Institute Gustave Roussy, Paris

0379

Oslo University Hospital Radiumhospitalet, Oslo

SE1 9RT

Guy's Hospital, London

SW3 6JJ

Royal Marsden Hospital, London

WC 1E

University College of London Hospital, London

M20 4BX

Christie Hospital NHS Foundatin Trust, Manchester

Sponsors

Lead Sponsor

Collaborators (2)

All Listed Sponsors
collaborator

Theradex

INDUSTRY

collaborator

ICON plc

INDUSTRY

lead

Lytix Biopharma AS

INDUSTRY