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

  • STATUS
    Recruiting
  • End date
    Dec 10, 2022
  • participants needed
    24
  • sponsor
    ImmuneOncia Therapeutics Inc.
Updated on 10 July 2021
platelet count
lymphoma
measurable disease
bone marrow procedure
neutrophil count
solid tumour
kidney function test

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.

Details
Condition Lymphoma, Lymphoproliferative Disorder, Lymphoma, Non-Hodgkin's Lymphoma, Solid Tumors, Solid Tumor, Solid Neoplasm, Solid Tumour, Lymphoproliferative disorders, lymphomas
Treatment IMC-002
Clinical Study IdentifierNCT04306224
SponsorImmuneOncia Therapeutics Inc.
Last Modified on10 July 2021

Eligibility

Yes No Not Sure

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 SIRP 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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