A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas

Phase 1

Completed

• Conditions: Solid Tumor; Lymphoma
• Interventions: Biological: IMC-002

• Registration Number: NCT04306224
• Lead Sponsor: ImmuneOncia Therapeutics Inc.

Brief Summary

This is the first-in-human, Phase I, open-label, multiple-ascending dose study to investigate the safety, tolerability, PK, PharmDyn, and clinical activity of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.

Male or female subjects 18 years and older with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas will be included in the study if they meet all the inclusion criteria and none of the exclusion criteria.

The study will consist of 2 parts:

Part 1: Dose Escalation Part 2: Expansion Cohorts

Detailed Description

Part 1: Dose Escalation

Part 2: Expansion Cohort The study may be amended in the future to include expansion cohorts in selected tumor types to further evaluate extended safety of IMC-002 at recommended Phase 2 dose in that tumor type. Sample size in the Dose Expansion part will be determined when the study is amended to include the expansion cohorts.

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Study Start: 2020-06-05
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMC-002	IMC-002	Dose escalation will follow the traditional 3+3 design.

Primary Outcome Measures

Name	Time	Method
Occurrence of dose-limiting toxicities (DLT)	For 28 days
Incidence and severity of adverse events (AEs)	2 years

Trial Locations

Locations (4)

Washington University School of Medicine - Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of