A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorImmuneOncia Therapeutics Inc.
About this trial
The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus
Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.
Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.
Adult age(as defined by respective country)
Disqualifiers
Previously treated with an anti-PD-L1 or anti-PD-1 antibody
Known presence of symptomatic CNS metastases
Any active autoimmune disease or a documented history of autoimmune disease
Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
Trial design
Design model
Single group
Treatments tested in this trial
IMC-001
DrugAll participants will receive the study drug, IMC-001, at 20 mg/kg Q2W via IV infusion over 60 minutes.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: IMC-001Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Percentage of participants achieving a best overall response (BOR) of CR or PR by centralized independent review using RECIST 1.1 criteria.
Time frame
Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).Secondary outcomes
1
Evaluate additional efficacy variables of IMC-001
Terms, frequency, severity, and seriousness of adverse events (AEs) and relationship of AEs to IMC-001
Time frame
through study completion, an average of 1 year2
Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
Progression-Free Survival (PFS), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1
Time frame
Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).3
Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
Duration of Response (DOR), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1
Time frame
Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).4
Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
Time to Progression (TTP), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1
Time frame
Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov