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Trial Title:
A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor
NCT ID:
NCT06365840
Condition:
TMB-H
Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
IMC-001,IMC-001-202,TMB-H
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IMC-001
Description:
All participants will receive the study drug, IMC-001, at 20 mg/kg Q2W via IV infusion
over 60 minutes.
Arm group label:
IMC-001
Summary:
The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or
locally advanced TMB-H solid tumor patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel.
2. Prior systemic radiation therapy must be completed at least 4 weeks before the first
dose of study drug.
3. Histologically or cytologically proven metastatic or locally advanced solid
tumors.The participant must have at least one measurable tumor lesion per RECIST
1.1.
4. Adult age(as defined by respective country)
5. The nature of the study and voluntarily sign an ICF
6. ECOG 0 or1
7. Adequate hematologic function, hepatic function, and renal function
Exclusion Criteria:
1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody
2. Known presence of symptomatic CNS metastases
3. Any active autoimmune disease or a documented history of autoimmune disease
4. Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C
virus
5. Pregnant or lactating
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 2024
Completion date:
December 2027
Lead sponsor:
Agency:
ImmuneOncia Therapeutics Inc.
Agency class:
Industry
Source:
ImmuneOncia Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06365840
