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Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Primary Purpose

Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMT-009
Sponsored by
Immunitas Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Solid Tumor, Lymphoma, CD161, Non small cell lung cancer, Head and neck squamous cell carcinoma, Triple negative breast cancer, Cutaneous squamous cell carcinoma, Hormone receptor positive breast cancer, Small bowel carcinoma, Esophageal cancer, Colorectal cancer, Diffuse large B-cell lymphoma, Hodgkin lymphoma, Burkitt lymphoma, T-cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Phase 1

  1. Males and females ≥18 years of age at the time of consent
  2. Patients who have histologically or cytologically-documented, unresectable locally advanced, or metastatic solid malignancy or designated lymphoma that is progressing or has failed the therapies listed below or who are intolerant of or are ineligible for or refuse standard of care therapy as detailed below.

    • Patients previously pre-treated with a checkpoint inhibitor must be anti-PD-L1 relapsed/refractory defined as having clear evidence of radiologic or clinical progression while on or within 4 months of their last anti-PD-L1 dose.
    • There is no limit to the number of prior treatment regimens a patient may have had prior to enrollment.

    Has one of the following solid tumor or lymphoma indications:

    • Non-small cell lung cancer (NSCLC) - squamous or non-squamous:

      • Must have received prior chemotherapy and a checkpoint inhibitor (either sequentially or in combination) per PD-L1 status
      • Must not have a documented EGFR, ALK, ROS, RET, BRAFV600E, Met exon 14 skipping, KRAS mutation
    • Head and neck squamous cell carcinoma (HNSCC) HPV+ or -:

      • Must have received prior treatment with a platinum-based chemotherapy and a checkpoint inhibitor (either sequentially or in combination) per PD-L1 status
    • Triple negative breast cancer (TNBC):

      • Must have received prior treatment with chemotherapy (anthracycline, and/or taxanes, and/or platinum, and/or gemcitabine); in combination with a checkpoint inhibitor if PD-L1+; a PARPi for patients with gBRCA mutations, and sacituzumab govitecan
    • Cutaneous squamous cell carcinoma:

      • Must have received prior treatment with a checkpoint inhibitor
    • Hormone receptor positive (HR+) breast cancer:

      - Must have received endocrine therapy, a CDK 4/6 inhibitor (preferably in combination with endocrine therapy in the 1st line or 2nd line setting or as monotherapy), a PI3K inhibitor and endocrine therapy for tumors with PIK3CA activating mutation; and a PARPi for patients with gBRCA mutations

    • Small bowel carcinoma:

      • Must have received prior treatment with at least one 5FU or capecitabine based regimen (such as but not limited to FOLFOX, FOLFIRI or CAPOX) with or without bevacizumab, and a PD1/PD-L1 inhibitor alone or in combination with CTLA4 inhibitor (for MSI-H or dMMR tumors)
    • Esophageal cancer:

      • Must have received prior treatment with a platinum-based chemotherapy and a checkpoint inhibitor (either sequentially or in combination per PD-L1 status), and an anti-HER2 agent for patients with known HER2 overexpressing tumors
    • Colorectal cancer (MSS & MSI-H/dMMR):

      • Must have received at least one 5FU chemotherapy-based regimen, with bevacizumab or cetuximab/panitumumab, and / or a PD1/PD-L1 (single agent or combination with CTLA4) for dMMR/MSI-H tumors
      • For patients with known BRAF V600E mutation: must have received prior treatment with a combination of encorafenib and cetuximab or panitumumab
    • Histologically confirmed diffuse large B cell lymphoma (DLBCL)

      • Must have received at least 2 prior lines of therapy including prior treatment with chemotherapy and an anti-CD20 antibody (ie, CHOP)
      • Must be ineligible or refuse therapies with demonstrated clinical benefit such as for example CAR-T or autologous stem cell transplant
    • Hodgkin lymphoma:

      - Must have received at least 3 prior systemic therapies, including combination chemotherapy (ie, ABVD).

    • Burkitt lymphoma:

      • Must have received at least 2 prior lines of therapy
      • Must be ineligible or refuse therapies with demonstrated clinical benefit
    • T cell lymphoma:

      • Must have received at least 2 prior systemic therapies, including combination chemotherapy (eg, CHOP).
  3. Patients with solid tumors have measurable disease based on RECIST 1.1. In hematological malignancies LYRIC/Lugano will be used.

Phase 2A Inclusion criteria for these patients will remain similar to those used during Phase 1.

Key Exclusion Criteria:

Phase 1

  1. Any prior Grade 4 immune-mediated adverse event (imAE) or Grade 3 imAE requiring steroid treatment (>10 mg/day prednisone or equivalent dose for more than 12 weeks) while receiving immunotherapy that has been documented within the 12 months prior to enrollment.
  2. Unresolved toxicity higher than Grade 1 CTCAE v 5 (or higher) attributed to any prior therapy/procedure at screening, except for alopecia.
  3. Prior history of serious hypersensitivity reaction to treatment with a monoclonal antibody
  4. Patients who are currently pregnant or breastfeeding
  5. Use of other investigational drugs (drugs not marketed for any indication) within 14 days or at least 5 half-lives (whichever is shorter) before investigational enrollment (Day 1, Cycle 1 dosing)
  6. Patient with history of malignancy (other than the one for which he/she participates in the study or than basal cell carcinoma definitively resected, or other in situ cancers) - unless the patient has undergone curative therapy with no evidence of that disease for 3 years
  7. Patients currently receiving cancer therapy (ie, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery, and/or tumor embolization) or expected to require any other form of antineoplastic therapy while on study.
  8. Patients with active, known or suspected autoimmune disease requiring systemic treatment (corticosteroids or other active immunosuppressive medications) within the past 6 months - with the exclusion of vitiligo, resolved asthma/atopia or alopecia areata; hypothyroidism stable on hormone replacement.
  9. Known CNS metastases (unless clinically stable for at least 4weeks prior to enrollment and off steroids for at least 7 days- exceptions above for physiologic replacement doses of hydrocortisone)
  10. Myocardial infarction, symptomatic congestive heart failure (NYHA> Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of screening
  11. Patient has history of or current HIV, Hepatitis B or C infection, even if not active and/or controlled

Phase 2A Exclusion criteria are expected to remain the same as Phase 1 unless there is a need to further refine expansion cohort populations for Phase 2a. Patients must have a CD161 and CLEC2D positive tumor demonstrated by the IHC CLIA assay for each analyte.

Sites / Locations

  • Site 5000Recruiting
  • Site 4100Recruiting
  • Site 4060Recruiting
  • Site 4500Recruiting
  • Site 9280Recruiting
  • Site 3000Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IMT-009 Dose Escalation

IMT-009 Phase 2a Cohort (s)

Arm Description

Participants will receive an assigned dose level of IMT-009 monotherapy in dose escalation. Up to 44 Participants will be enrolled in the Phase 1 portion of the study.

Each Cohort will evaluate IMT-009 monotherapy in up to 25 Participants

Outcomes

Primary Outcome Measures

Dose Escalation - number of participants with dose limiting toxicities (DLTs) from IMT-009 monotherapy
Dose Escalation- Number of participants with adverse events following administration of IMT-009
Phase 2a Cohort(s) Overall Response Rate (ORR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess anti-tumor activity of IMT-009 in each cohort

Secondary Outcome Measures

Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Area under the plasma concentration-time curve (AUC) of IMT-009 when given as monotherapy.
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Maximum plasma concentration (Cmax) of IMT-009 when given as monotherapy.
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Minimum plasma concentration (Cmin) of IMT-009 when given as monotherapy.
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Volume of distribution (Vd) of IMT-009 when given as monotherapy.
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Apparent volume of distribution at steady state determined after intravenous administration (Vss) of IMT-009 when given as monotherapy.
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Terminal half-life (t1/2) of IMT-009 when given as monotherapy.
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Time to maximum plasma concentration (Tmax) of IMT-009 when given as monotherapy.
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Clearance of IMT-009 when given as monotherapy.
Clearance is the volume of plasma cleared of IMT-009 by the body per unit time.
Dose Escalation and Phase 2a Cohort(s)- Number of participants who develop detectable anti-drug antibodies.
Dose Escalation- Receptor Occupancy (RO) to determine the target engagement of IMT-009.
Dose Escalation- Overall Response Rate (ORR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess anti-tumor activity of IMT-009
Dose Escalation and Phase 2a Cohort(s)- Clinical benefit rate (CBR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess preliminary anti-tumor activity of IMT-009
Dose Escalation and Phase 2a Cohort(s)- Duration of Response (DOR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess preliminary anti-tumor activity of IMT-009
Dose Escalation and Phase 2a Cohort(s)- Progression-free survival (PFS) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess preliminary anti-tumor activity of IMT-009
Dose Escalation and Phase 2a Cohort(s)- Overall survival (OS) to assess preliminary anti-tumor activity of IMT-009
Phase 2a Cohort(s)- Number of participants with adverse events following administration of IMT-009

Full Information

First Posted
September 23, 2022
Last Updated
May 22, 2023
Sponsor
Immunitas Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05565417
Brief Title
Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
Official Title
A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunitas Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1/2a open-label, multicenter, dose escalation and dose expansion trial in which IMT-009 will be administered by the intravenous (IV) route to participants with solid tumors or lymphomas. The main goals of this study are to: Find the recommended dose of IMT-009 that can be safely given to participants Learn more about the side effects of IMT-009 Learn more about pharmacokinetics of IMT-009 Learn more about the effectiveness of IMT-009 Learn more about different pharmacokinetic biomarkers and how they might change in the presence of IMT-009
Detailed Description
IMT-009 is an Fc-attenuated monoclonal antibody that binds with high affinity and selectivity to CD161, a receptor that is broadly expressed on NK and a subset of memory T cells, blocking interactions between the receptor and its cognate ligand, CLEC2D, which is expressed on the surface of both cancer cells and immune cells. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. This is a Phase 1/2a, open label dose escalation study of IMT-009, a fully human monoclonal antibody targeting CD161, given as a single agent in Phase 1 and potentially in combination with other antineoplastic agents in Phase 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Squamous Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Small Bowel Cancer, Esophageal Cancer, Colorectal Cancer, Diffuse Large B Cell Lymphoma, Hodgkin Lymphoma, Burkitt Lymphoma, T-cell Lymphoma
Keywords
Solid Tumor, Lymphoma, CD161, Non small cell lung cancer, Head and neck squamous cell carcinoma, Triple negative breast cancer, Cutaneous squamous cell carcinoma, Hormone receptor positive breast cancer, Small bowel carcinoma, Esophageal cancer, Colorectal cancer, Diffuse large B-cell lymphoma, Hodgkin lymphoma, Burkitt lymphoma, T-cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMT-009 Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive an assigned dose level of IMT-009 monotherapy in dose escalation. Up to 44 Participants will be enrolled in the Phase 1 portion of the study.
Arm Title
IMT-009 Phase 2a Cohort (s)
Arm Type
Experimental
Arm Description
Each Cohort will evaluate IMT-009 monotherapy in up to 25 Participants
Intervention Type
Drug
Intervention Name(s)
IMT-009
Intervention Description
Participants will receive an IV infusion of IMT-009 on Day 1 during each 21-day cycle.
Primary Outcome Measure Information:
Title
Dose Escalation - number of participants with dose limiting toxicities (DLTs) from IMT-009 monotherapy
Time Frame
21 days (Cycle 1 Day 1- Cycle 1 Day 21)
Title
Dose Escalation- Number of participants with adverse events following administration of IMT-009
Time Frame
From informed consent (Cycle 0 Day -28) to 30 days after the last dose of IMT-009. Each cycle is 21 days
Title
Phase 2a Cohort(s) Overall Response Rate (ORR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess anti-tumor activity of IMT-009 in each cohort
Time Frame
Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each cycle is 21 days.
Secondary Outcome Measure Information:
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Area under the plasma concentration-time curve (AUC) of IMT-009 when given as monotherapy.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Maximum plasma concentration (Cmax) of IMT-009 when given as monotherapy.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Minimum plasma concentration (Cmin) of IMT-009 when given as monotherapy.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Volume of distribution (Vd) of IMT-009 when given as monotherapy.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Apparent volume of distribution at steady state determined after intravenous administration (Vss) of IMT-009 when given as monotherapy.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Terminal half-life (t1/2) of IMT-009 when given as monotherapy.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Time to maximum plasma concentration (Tmax) of IMT-009 when given as monotherapy.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Pharmacokinetic Analysis: Clearance of IMT-009 when given as monotherapy.
Description
Clearance is the volume of plasma cleared of IMT-009 by the body per unit time.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Number of participants who develop detectable anti-drug antibodies.
Time Frame
Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation- Receptor Occupancy (RO) to determine the target engagement of IMT-009.
Time Frame
Cycle 1 Day 1 to treatment discontinuation, up to 2 years. Cycles are 21 days.
Title
Dose Escalation- Overall Response Rate (ORR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess anti-tumor activity of IMT-009
Time Frame
Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each cycle is 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Clinical benefit rate (CBR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess preliminary anti-tumor activity of IMT-009
Time Frame
Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each cycle is 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Duration of Response (DOR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess preliminary anti-tumor activity of IMT-009
Time Frame
Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each cycle is 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Progression-free survival (PFS) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess preliminary anti-tumor activity of IMT-009
Time Frame
Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each cycle is 21 days.
Title
Dose Escalation and Phase 2a Cohort(s)- Overall survival (OS) to assess preliminary anti-tumor activity of IMT-009
Time Frame
Cycle 1 Day to discontinuation of study drug, then every 3 months for up to 2 years
Title
Phase 2a Cohort(s)- Number of participants with adverse events following administration of IMT-009
Time Frame
From informed consent (Cycle 0 Day -28) to 30 days after the last dose of IMT-009. Each cycle is 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Phase 1 Males and females ≥18 years of age at the time of consent Patients who have histologically or cytologically-documented, unresectable locally advanced, or metastatic solid malignancy or designated lymphoma that is progressing or has failed the therapies listed below or who are intolerant of or are ineligible for or refuse standard of care therapy as detailed below. Patients previously pre-treated with a checkpoint inhibitor must be anti-PD-L1 relapsed/refractory defined as having clear evidence of radiologic or clinical progression while on or within 4 months of their last anti-PD-L1 dose. There is no limit to the number of prior treatment regimens a patient may have had prior to enrollment. Has one of the following solid tumor or lymphoma indications: Non-small cell lung cancer (NSCLC) - squamous or non-squamous: Must have received prior chemotherapy and a checkpoint inhibitor (either sequentially or in combination) per PD-L1 status Must not have a documented EGFR, ALK, ROS, RET, BRAFV600E, Met exon 14 skipping, KRAS mutation Head and neck squamous cell carcinoma (HNSCC) HPV+ or -: Must have received prior treatment with a platinum-based chemotherapy and a checkpoint inhibitor (either sequentially or in combination) per PD-L1 status Triple negative breast cancer (TNBC): Must have received prior treatment with chemotherapy (anthracycline, and/or taxanes, and/or platinum, and/or gemcitabine); in combination with a checkpoint inhibitor if PD-L1+; a PARPi for patients with gBRCA mutations, and sacituzumab govitecan Cutaneous squamous cell carcinoma: Must have received prior treatment with a checkpoint inhibitor Hormone receptor positive (HR+) breast cancer: - Must have received endocrine therapy, a CDK 4/6 inhibitor (preferably in combination with endocrine therapy in the 1st line or 2nd line setting or as monotherapy), a PI3K inhibitor and endocrine therapy for tumors with PIK3CA activating mutation; and a PARPi for patients with gBRCA mutations Small bowel carcinoma: Must have received prior treatment with at least one 5FU or capecitabine based regimen (such as but not limited to FOLFOX, FOLFIRI or CAPOX) with or without bevacizumab, and a PD1/PD-L1 inhibitor alone or in combination with CTLA4 inhibitor (for MSI-H or dMMR tumors) Esophageal cancer: Must have received prior treatment with a platinum-based chemotherapy and a checkpoint inhibitor (either sequentially or in combination per PD-L1 status), and an anti-HER2 agent for patients with known HER2 overexpressing tumors Colorectal cancer (MSS & MSI-H/dMMR): Must have received at least one 5FU chemotherapy-based regimen, with bevacizumab or cetuximab/panitumumab, and / or a PD1/PD-L1 (single agent or combination with CTLA4) for dMMR/MSI-H tumors For patients with known BRAF V600E mutation: must have received prior treatment with a combination of encorafenib and cetuximab or panitumumab Histologically confirmed diffuse large B cell lymphoma (DLBCL) Must have received at least 2 prior lines of therapy including prior treatment with chemotherapy and an anti-CD20 antibody (ie, CHOP) Must be ineligible or refuse therapies with demonstrated clinical benefit such as for example CAR-T or autologous stem cell transplant Hodgkin lymphoma: - Must have received at least 3 prior systemic therapies, including combination chemotherapy (ie, ABVD). Burkitt lymphoma: Must have received at least 2 prior lines of therapy Must be ineligible or refuse therapies with demonstrated clinical benefit T cell lymphoma: Must have received at least 2 prior systemic therapies, including combination chemotherapy (eg, CHOP). Patients with solid tumors have measurable disease based on RECIST 1.1. In hematological malignancies LYRIC/Lugano will be used. Phase 2A Inclusion criteria for these patients will remain similar to those used during Phase 1. Key Exclusion Criteria: Phase 1 Any prior Grade 4 immune-mediated adverse event (imAE) or Grade 3 imAE requiring steroid treatment (>10 mg/day prednisone or equivalent dose for more than 12 weeks) while receiving immunotherapy that has been documented within the 12 months prior to enrollment. Unresolved toxicity higher than Grade 1 CTCAE v 5 (or higher) attributed to any prior therapy/procedure at screening, except for alopecia. Prior history of serious hypersensitivity reaction to treatment with a monoclonal antibody Patients who are currently pregnant or breastfeeding Use of other investigational drugs (drugs not marketed for any indication) within 14 days or at least 5 half-lives (whichever is shorter) before investigational enrollment (Day 1, Cycle 1 dosing) Patient with history of malignancy (other than the one for which he/she participates in the study or than basal cell carcinoma definitively resected, or other in situ cancers) - unless the patient has undergone curative therapy with no evidence of that disease for 3 years Patients currently receiving cancer therapy (ie, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery, and/or tumor embolization) or expected to require any other form of antineoplastic therapy while on study. Patients with active, known or suspected autoimmune disease requiring systemic treatment (corticosteroids or other active immunosuppressive medications) within the past 6 months - with the exclusion of vitiligo, resolved asthma/atopia or alopecia areata; hypothyroidism stable on hormone replacement. Known CNS metastases (unless clinically stable for at least 4weeks prior to enrollment and off steroids for at least 7 days- exceptions above for physiologic replacement doses of hydrocortisone) Myocardial infarction, symptomatic congestive heart failure (NYHA> Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of screening Patient has history of or current HIV, Hepatitis B or C infection, even if not active and/or controlled Phase 2A Exclusion criteria are expected to remain the same as Phase 1 unless there is a need to further refine expansion cohort populations for Phase 2a. Patients must have a CD161 and CLEC2D positive tumor demonstrated by the IHC CLIA assay for each analyte.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Immunitas Therapeutics
Phone
781.996.0564
Email
CTInformation@immuntastx.com
Facility Information:
Facility Name
Site 5000
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 4100
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 4060
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 4500
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 9280
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 3000
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

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