Status:
COMPLETED
A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
Lead Sponsor:
ImmuneOncia Therapeutics Inc.
Conditions:
Solid Tumor
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 lo...
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 recommen...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04306224
Start Date
June 5 2020
End Date
October 7 2022
Last Update
April 12 2024
Active Locations (4)
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1
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
NEXT Oncology
San Antonio, Texas, United States, 78229
4
Seoul National University Hospital
Seoul, South Korea, 03080