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

NCT ID: NCT04306224

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2022-10-07

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.

Conditions

Solid Tumor; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMC-002

Dose escalation will follow the traditional 3+3 design.

Group Type: EXPERIMENTAL

IMC-002

Intervention Type: BIOLOGICAL

IMC-002 blocks the interaction between CD47 and SIRPα.

Interventions

IMC-002

IMC-002 blocks the interaction between CD47 and SIRPα.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Signed informed consent form (ICF)

2. Adult (18 years or older)

3. 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

4. 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

5. Availability of tumor archival material or fresh biopsies for measurement of CD47

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening and an estimated life expectancy of at least 3 months

7. Adequate hematologic function, hepatic function, and renal function

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria apply:

1. Treatment with nonpermitted drugs (within 28 days before Day 1).

2. Prior treatment with a CD47 or SIRPα targeting agent

3. Concurrent anticancer treatments within 28 days before Day 1/first study treatment administration

4. Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period

5. 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

6. Primary central nervous system (CNS) disease or leptomeningeal disease; known CNS metastases unless treated

7. Comorbidities/medical history of any significant diseases that in the judgment of the Investigator would make the subject inappropriate for this study

8. Active infection requiring systemic therapy within 14 days before Day 1

9. Persisting toxicities Grade > 1 NCI-CTCAE Version 5.0 related to prior anticancer treatment

10. Pregnant or lactating

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneOncia Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HEUNG TAE KIM

Role: STUDY_DIRECTOR

ImmuneOncia Therapeutics Inc.

Locations

Washington University School of Medicine - Siteman Cancer Center

St 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, , South Korea

Countries

United States; South Korea

Other Identifiers

IMC-002-101

Identifier Type: -

Identifier Source: org_study_id