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

Phase 2

Not yet recruiting

• Conditions: TMB-H; Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors
• Interventions: Drug: IMC-001

• Registration Number: NCT06365840
• Lead Sponsor: ImmuneOncia Therapeutics Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Study Start: 2024-06
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMC-001	IMC-001	-

Primary Outcome Measures

Name	Time	Method
ORR	1 year (Not confirmed yet)	Percentage of participants achieving a best overall response (BOR) of CR or PR by centralized independent review using RECIST 1.1 criteria.