A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04306224|
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : April 28, 2021
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Dose escalation will consist of two distinct sub-parts (1A and 1B).|
|Masking:||None (Open Label)|
|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|
Dose escalation will follow the traditional 3+3 design.
IMC-002 blocks the interaction between CD47 and SIRPα.
- Occurrence of dose-limiting toxicities (DLT) [ Time Frame: For 28 days ]
- Incidence and severity of adverse events (AEs) [ Time Frame: 2 years ]
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
|Contact: Ji Hye Lee||+82 31 306 firstname.lastname@example.org|
|Contact: EunJeong Seo||+82 31 306 8195||EJSeo@immuneoncia.com|
|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 email@example.com|
|Principal Investigator: Aung Naing, MD|
|San Antonio, Texas, United States, 78229|
|Contact: Amanda Betancourt, MS, M.Jur. 210-580-9513 firstname.lastname@example.org|
|Principal Investigator: Raghad M. Abdul Karim, MD|
|Study Director:||Ji Hye Lee||ImmuneOncia Therapeutics Inc.|