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

NCT04306224 | Completed Phase 1 FDA Drug

• 1 other identifier: IMC-002-101
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 4

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

Conditions

Solid Tumor; Lymphoma

Keywords

IMC-002; Phase I; CD47; SIRPα

Outcome Measures

Primary Outcomes (2)

• Occurrence of dose-limiting toxicities (DLT)

  For 28 days

• Incidence and severity of adverse events (AEs)

  2 years

Study Arms (1)

IMC-002

EXPERIMENTAL

Dose escalation will follow the traditional 3+3 design.

Biological: IMC-002

Interventions

IMC-002 BIOLOGICAL

IMC-002 blocks the interaction between CD47 and SIRPα.

IMC-002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are eligible to be included in the study only if all of the following criteria apply:
• Signed informed consent form (ICF)
• Adult (18 years or older)
• Histologically or cytologically proven metastatic or locally advanced solid tumors and relapsed or refractory lymphomas, for which no standard therapy known to prolong survival exists or have relapsed/refractory/PD following the last line of treatment
• Solid tumors must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Lymphomas must have at least 1 measurable lesion according to the Lugano criteria with the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification
• Availability of tumor archival material or fresh biopsies for measurement of CD47
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening and an estimated life expectancy of at least 3 months
• Adequate hematologic function, hepatic function, and renal function

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria apply:
• Treatment with nonpermitted drugs (within 28 days before Day 1).
• Prior treatment with a CD47 or SIRPα targeting agent
• Concurrent anticancer treatments within 28 days before Day 1/first study treatment administration
• Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period
• Previous malignant disease other than the target malignancy for this study, except adequately treated Stage I or II cancers from which the subject is currently in complete remission per the Investigator's clinical judgment
• Primary central nervous system (CNS) disease or leptomeningeal disease; known CNS metastases unless treated
• Comorbidities/medical history of any significant diseases that in the judgment of the Investigator would make the subject inappropriate for this study
• Active infection requiring systemic therapy within 14 days before Day 1
• Persisting toxicities Grade \> 1 NCI-CTCAE Version 5.0 related to prior anticancer treatment
• Pregnant or lactating

Sponsors & Collaborators

• ImmuneOncia Therapeutics Inc.: lead

Study Sites (4)

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• HEUNG TAE KIM

  ImmuneOncia Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation will consist of two distinct sub-parts (1A and 1B).

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 12, 2020
• Study Start: June 5, 2020
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); KR (1)