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

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ClinicalTrials.gov Identifier: NCT04306224
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Biological: IMC-002 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation will consist of two distinct sub-parts (1A and 1B).
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: IMC-002
Dose escalation will follow the traditional 3+3 design.
Biological: IMC-002
IMC-002 blocks the interaction between CD47 and SIRPα.




Primary Outcome Measures :
  1. Occurrence of dose-limiting toxicities (DLT) [ Time Frame: For 28 days ]
  2. Incidence and severity of adverse events (AEs) [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306224


Contacts
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Contact: Ji Hye Lee +82 31 306 8199 jhlee@immuneoncia.com
Contact: EunJeong Seo +82 31 306 8195 EJSeo@immuneoncia.com

Locations
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United States, Missouri
Washington University School of Medicine - Siteman Cancer Center Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lacey McQuinn, MPH, CCRP    713-792-5578    lmcquinn@mdanderson.org   
Principal Investigator: Aung Naing, MD         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Amanda Betancourt, MS, M.Jur.    210-580-9513    abetancourt@nextoncology.com   
Principal Investigator: Raghad M. Abdul Karim, MD         
Sponsors and Collaborators
ImmuneOncia Therapeutics Inc.
Investigators
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Study Director: Ji Hye Lee ImmuneOncia Therapeutics Inc.
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Responsible Party: ImmuneOncia Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04306224    
Other Study ID Numbers: IMC-002-101
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmuneOncia Therapeutics Inc.:
IMC-002
Phase I
CD47
SIRPα
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases