Multiple Solid Tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: Ladiratuzumab vedotin
Product Code: [SGN-LIV1A ]
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Ladiratuzumab vedotin
CAS Number: 1629760-29-7
Current Sponsor
Sponsors
SEATTLE GENETICS, INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All Cohorts of Part A and Part B •Measurable disease according to RECIST v1.1 as assessed by the investigator •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 Cohort 1: SCLC •Must have extensive stage disease •No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage •May have received prior anti-PD(L)1 therapy Cohort 2: NSCLC-squamous •Must have unresectable locally advanced or metastatic disease •Must have disease progression during or following systemic therapy a. Participants must have progressed during or after a platinum based combination therapy administered for the treatment of metastatic disease b. Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced stage disease. •No more than 1 prior line of cytotoxic chemotherapy for their advanced disease •Must have received prior anti-PD(L)1 therapy, unless contraindicated Cohort 3: NSCLC-nonsquamous •Must have unresectable locally advanced or metastatic disease •Must have disease progression during or following systemic therapy a. Participants must have progressed during or after a platinumbased combination therapy administered for the treatment of metastatic disease b. Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease. •Must have had prior platinum-based chemotherapy •No more than 1 prior line of cytotoxic chemotherapy for their advanced disease •Must have received prior anti-PD(L)1 therapy, unless contraindicated •Cohort 4: HNSCC •Must have unresectable locally recurrent or metastatic disease •Must have disease progression during or following prior line of systemic therapy a. Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; or b. Recurrence/progression within 6 months of last dose of platinum therapy given as part of a multimodal therapy in the curative setting •No more than 1 line of cytotoxic chemotherapy for their advanced disease •May have received prior anti-PD(L)1 therapy, unless contraindicated Cohort 5: esophageal-squamous •Must have unresectable locally advanced or metastatic disease •Must have disease progression during or following systemic therapy •Must have had prior platinum-based chemotherapy •No more than 1 line of cytotoxic chemotherapy for their advanced disease Cohort 6: gastric and GEJ adenocarcinoma •Must have unresectable locally advanced or metastatic disease •Must have received prior platinum-based therapy •Must have disease progression during or following systemic therapy •Participants with known human epidermal growth factor receptor 2(HER2) overexpression must have received prior HER2-targeted therapy •No more than 1 line of prior cytotoxic chemotherapy for their advanced disease 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 158 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: All Cohorts of Part A and Part B •Active concurrent malignancy or a previous malignancy within the past 3 years •Known active central nervous system lesions •Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher) •Ongoing sensory or motor neuropathy of Grade =2 •Has received prior radiotherapy within 2 weeks of start of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate antitumor activity of LV as measured by investigator-determined confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1);Secondary Objective: -Evaluate the safety and tolerability of LV as measured by type, incidence, severity, seriousness, and relatedness of adverse events (AEs) -Evaluate stability and control of disease as measured by disease control rate (DCR) -Evaluate durability of response as measured by duration of response (DOR) -Assess progression-free survival (PFS) -Assess survival as measured by overall survival (OS) -Assess pharmacokinetics (PK) and immunogenicity of LV ;Primary end point(s): -Evaluate antitumor activity of LV ;Timepoint(s) of evaluation of this end point: -Investigator-determined confirmed ORR as measured by RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Evaluate the safety and tolerability of LV -Evaluate stability and control of disease -Evaluate durability of response in subjects who respond to LV -Evaluate PFS of subjects treated with LV -Evaluate survival of subjects treated with LV -Assess PK of LV -Assess immunogenicity of LV -Assess biomarkers of biological activity and resistance and predictive biomarkers of response;Timepoint(s) of evaluation of this end point: -Type, incidence, severity, seriousness, and relatedness of AEs -Investigator-determined DCR as measured by RECIST v1.1 -Investigator-determined DOR as measured by RECIST v1.1 -Investigator-determined PFS as measured by RECIST v1.1 -OS -Selected PK parameters for LV, total antibody, and MMAE -Incidence of ATAs to LV -Relationship between biomarkers in blood and tumor tissue to efficacy, safety, or other biomarker endpoints following treatment with LV | — |
Countries
Australia, Italy, Korea, Republic of, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactSeagen Clinical Trial Information
Seattle Genetics, Inc.
Outcome results
None listed