Advanced/Metastatic Non-squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
Part 1: The safety and tolerability of OMTX705 in combination with tislelizumab, carboplatin and pemetrexed will be assessed by: • The nature and frequency of DLTs. • Frequency, duration, and severity of treatment emerging adverse events (TEAEs) per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)., • Changes in vital signs, serum chemistry and hematology. • Treatment modifications condensed as percentage of relative dose intensity and other dose endpoints. • The MTD dose or recommended Part 2 dose., Part 2: Objective response rate (ORR), as determined by the Investigator, according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
Detailed description
Part 1 and 2: Additional efficacy endpoints will be evaluated by using RECIST 1.1: • Response-associated endpoints: disease control rate (DCR)=complete response (CR) + partial response (PR) + stable disease (SD) ≥ 1st, 2nd and 3rd postbaseline computed tomography scan evaluation, duration of response (DoR), and time to response., • Time-to-event efficacy endpoints: progression-free survival (PFS), proportion of participants without progression/death at 3, 6, and 12 months and every 3 months thereafter. Overall survival (OS) and proportion of participants alive at 3, 6, 12, 18 and 24 months., Additional safety data will be evaluated by assessing: • Frequency, duration, seriousness, relatedness, and severity of TEAEs, per CTCAE v5.0 • Changes in vital signs, serum chemistry and hematology. • Treatment modifications condensed as percentage of relative dose intensity and other dose endpoints., Part 1 and Part 2 immunogenicity of OMTX705 will be assessed by: • Quantification (titer) of anti-drug antibodies (ADAs) against OMTX705 and percentage of ADA positive participants., Part 1 and Part 2 pharmacokinetics profile of OMTX705 with pemetrexed/carboplatin /tislelizumab: • Blood concentrations of conjugated antibody and unconjugated payload (TAM470) listed and summarized using descriptive statistics.
Interventions
DRUGPemetrexed EVER Pharma 25 mg/ml concentrate for solution for infusion
DRUGCarboplatino Aurovitas 10 mg/ml concentrado para solución para perfusión EFG
DRUGPemetrexed Glenmark 10 mg/ml solución para perfusión
DRUGOMTX705
Sponsors
Oncomatryx Biopharma S.L.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The safety and tolerability of OMTX705 in combination with tislelizumab, carboplatin and pemetrexed will be assessed by: • The nature and frequency of DLTs. • Frequency, duration, and severity of treatment emerging adverse events (TEAEs) per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)., • Changes in vital signs, serum chemistry and hematology. • Treatment modifications condensed as percentage of relative dose intensity and other dose endpoints. • The MTD dose or recommended Part 2 dose., Part 2: Objective response rate (ORR), as determined by the Investigator, according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and 2: Additional efficacy endpoints will be evaluated by using RECIST 1.1: • Response-associated endpoints: disease control rate (DCR)=complete response (CR) + partial response (PR) + stable disease (SD) ≥ 1st, 2nd and 3rd postbaseline computed tomography scan evaluation, duration of response (DoR), and time to response., • Time-to-event efficacy endpoints: progression-free survival (PFS), proportion of participants without progression/death at 3, 6, and 12 months and every 3 months thereafter. Overall survival (OS) and proportion of participants alive at 3, 6, 12, 18 and 24 months., Additional safety data will be evaluated by assessing: • Frequency, duration, seriousness, relatedness, and severity of TEAEs, per CTCAE v5.0 • Changes in vital signs, serum chemistry and hematology. • Treatment modifications condensed as percentage of relative dose intensity and other dose endpoints., Part 1 and Part 2 immunogenicity of OMTX705 will be assessed by: • Quantification (titer) of ant | — |
Countries
Spain
Outcome results
None listed