Clinical Trials /

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

NCT04306224

Description:

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. After providing informed consent, subjects will be assessed for study eligibility during the Screening period (Day -28 to Day -1). The study will consist of 2 parts: Part 1: Dose Escalation Part 2: Expansion Cohorts

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: IMC-002-101
  • NCT ID: NCT04306224

Conditions

  • Solid Tumor
  • Lymphoma

Interventions

DrugSynonymsArms
IMC-002IMC-002

Purpose

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. After providing informed consent, subjects will be assessed for study eligibility during the Screening period (Day -28 to Day -1). The study will consist of 2 parts: Part 1: Dose Escalation Part 2: Expansion Cohorts

Detailed Description

      Part 1: Dose Escalation Dose escalation will follow the traditional 3+3 design. Cohorts of 3
      subjects will be given escalating doses of IMC-002 once every 2 weeks as an IV infusion over
      60 minutes. Dose-limiting toxicities (DLT) will be assessed during the 28-day DLT evaluation
      period. The decision to escalate to the next dose level will be based on safety assessments
      after all subjects of a cohort have reached Day 28 (DLT evaluation period).

      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.
    

Trial Arms

NameTypeDescriptionInterventions
IMC-002ExperimentalDose escalation will follow the traditional 3+3 design.
  • IMC-002

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of dose-limiting toxicities (DLT)
Time Frame:For 28 days
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ImmuneOncia Therapeutics Inc.

Trial Keywords

  • IMC-002
  • Phase I
  • CD47
  • SIRPα

Last Updated

May 21, 2020