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

Lymphoma Clinical Trial

Official title:

A First-in-Human, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306224
• Other study ID #: IMC-002-101
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2020
• Est. completion date: October 7, 2022

Study information

• Verified date: April 2024
• Source: ImmuneOncia Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 SIRPa 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

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

Biological:
• IMC-002
IMC-002 blocks the interaction between CD47 and SIRPa.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Washington University School of Medicine - Siteman Cancer Center	Saint Louis	Missouri
United States	NEXT Oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ImmuneOncia Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dose-limiting toxicities (DLT)		For 28 days
Primary	Incidence and severity of adverse events (AEs)		2 years