A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor

ImmuneOncia Therapeutics

Status and phase: Not yet enrolling; Phase 2

Conditions: TMB-H; Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors

Treatments: Drug: IMC-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06365840

IMC-001-202

Details and patient eligibility

About

The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

IMC-001

Experimental group

Treatment:

Drug: IMC-001