Solid tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Code: LAG525
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not available
Current Sponsor code: LAG525
Concentration unit: mg/ml milligram(s)/millilitre
Concen
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase I part: - Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 1), who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists Phase II part: •Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression. Additionally the following must apply: •Group 1: NSCLC •Group 2: Melanoma •Group 3: Renal cancer •Group 4: Mesothelioma •Group 5: TNBC •Eastern Cooperative Oncology Group (ECOG) Performance Status = 1 Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 276 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: History of severe hypersensitivity reactions to study treatment ingredients or other mAbs •Active, known or suspected autoimmune disease •Active infection requiring systemic antibiotic therapy •HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection •Patients receiving chronic treatment with systemic steroid therapy (> 10 mg/day prednisone or equivalent) within 7 days of the first dose of study treatment, other than replacement-dose corticosteroids in the setting of adrenal insufficiency •Patients receiving systemic treatment with any immunosupressive medication •Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment •Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. •Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks •History of drug-induced pneumonitis or current pneumonitis. Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I part - To estimate the RP2D or MTD for: ? Single agent LAG525 in all patients (including for Japanese patients) ? Combination of LAG525 and PDR001. Phase II part - To estimate the overall response rate per RECIST V1.1: ? Single agent LAG525 ? Combination of LAG525 and PDR001;Secondary Objective: Key Secondary Objectives: 1) To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 2) To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 3) To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 4) To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 Other Secondary Objectives are defined in the protocol.;Primary end point(s): Phase I part: - The incidence of dose limiting toxicities ( DLTs) with single agent LAG525 & for the combination treatment of LAG525 and PDR001 Phase II part: Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. of single agent LAG525 & the combination of LAG525 and PDR001.;Timepoint(s) of evaluation of this end point: Phase I: - the incidence of DLTs continously: during the first cycle of treatment with single agent LAG525; for the combination treatment of LAG525 and PDR001, the DLT window will be 2 cycles of the treatment. Phase II: - Every 8 weeks ± 1 week after Cycle 1 Day 1 until 40 weeks , then every 12 weeks until progression of disease per irRC or patient withdrawal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. a) Safety incidence and severity if adverse events (AEs) and serious adverse events (SAEs) including changes in laboratory parameters, vital signs and ECGs; b) Tolerability: Dose interruptions, reductions and dose intensity. 2. Serum PK parameters (e.g. AUC, Cmax, Tmax, t1/2 half-life)) 3. Presence and/ or concentration of anti-LAG525 and anti-PDR001 antibodies 4. Phase I Part: ORR, progression free survival (PFS), duration of response (DOR) and disease control rate (DCR); Phase II Part: ORR per immune related Response Criteria (irRC), PFS, DOR, DCR per RECIST V1.1 and per irRC ;Timepoint(s) of evaluation of this end point: 1. Assessed continuously 2. Every Cycle until Cycle 6 3. Every Cycle until Cycle 6 4. Every 8 weeks ± 1 week after Cycle 1 Day 1 until 40 weeks , then every 12 weeks until progression of disease per irRC or patient withdrawal. | — |
Countries
Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Singapore, Spain, Taiwan, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed