Back to resultsA Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
Primary Purpose
Solid Tumor, Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IMC-002
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring IMC-002, Phase I, CD47, SIRPα
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Sites / Locations
- Washington University School of Medicine - Siteman Cancer CenterRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- NEXT OncologyRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMC-002
Arm Description
Dose escalation will follow the traditional 3+3 design.
Outcomes
Primary Outcome Measures
Occurrence of dose-limiting toxicities (DLT)
Incidence and severity of adverse events (AEs)
Secondary Outcome Measures
Full Information
NCT ID
NCT04306224
First Posted
March 6, 2020
Last Updated
June 29, 2021
Sponsor
ImmuneOncia Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04306224
Brief Title
A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmuneOncia Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Lymphoma
Keywords
IMC-002, Phase I, CD47, SIRPα
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Dose escalation will consist of two distinct sub-parts (1A and 1B).
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMC-002
Arm Type
Experimental
Arm Description
Dose escalation will follow the traditional 3+3 design.
Intervention Type
Biological
Intervention Name(s)
IMC-002
Intervention Description
IMC-002 blocks the interaction between CD47 and SIRPα.
Primary Outcome Measure Information:
Title
Occurrence of dose-limiting toxicities (DLT)
Time Frame
For 28 days
Title
Incidence and severity of adverse events (AEs)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Hye Lee
Phone
+82 31 306 8199
Email
jhlee@immuneoncia.com
First Name & Middle Initial & Last Name or Official Title & Degree
EunJeong Seo
Phone
+82 31 306 8195
Email
EJSeo@immuneoncia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Hye Lee
Organizational Affiliation
ImmuneOncia Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Washington University School of Medicine - Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassy Benedict
Phone
314-273-3127
Email
cassy.benedict@wustl.edu
First Name & Middle Initial & Last Name & Degree
Haeseong Park, MD
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lacey McQuinn, MPH, CCRP
Phone
713-792-5578
Email
lmcquinn@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Aung Naing, MD
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Betancourt, MS, M.Jur.
Phone
210-580-9513
Email
abetancourt@nextoncology.com
First Name & Middle Initial & Last Name & Degree
Raghad M. Abdul Karim, MD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heekyoung Koo
Phone
+82 2 2072 1672
Email
kooheekyoung@gmail.com
First Name & Middle Initial & Last Name & Degree
Bhumsuk KIM
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
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