ACTIVE_NOT_RECRUITING

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

Conditions

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 Follicular Lymphoma Solid Tumor Lymphoma CD161 Hormone receptor positive breast cancer Small bowel carcinoma Diffuse large B-cell lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-11-28

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05565417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males and females ≥18 years of age at the time of consent 2. Willingness and capacity to provide written consent 3. 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. * 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); sacituzumab govitecan; a checkpoint inhibitor if PD-L1+; a PARPi for patients with gBRCA mutations * Cutaneous squamous cell carcinoma: * Must have received prior treatment with a checkpoint inhibitor * Hormone receptor positive (HR+) breast cancer: * 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: * Burkitt lymphoma: * Must have received at least 2 prior lines of therapy * Must be ineligible or refuse therapies with demonstrated clinical benefit * Follicular lymphoma: * Must have received 3 prior lines of therapy, and must have received rituximab and chemotherapy 4. Patients with solid tumors have measurable disease based on RECIST 1.1. In hematological malignancies LYRIC/Lugano will be used. 5. In defined cohorts, patients must have confirmed positive expression of CD161. Patients must have an available archival biopsy sample or agree to have a fresh biopsy obtained to confirm positivity and must agree to a mandatory newly obtained on-treatment biopsy. 1. Must have histologically or cytologically-documented, unresectable, locally-advanced or metastatic MSS CRC with documented IHC for MMR and/or DNA for MSI consistent with MSS CRC. 2. Eligible for treatment with fruquintinib according to the FDA-approved USPI 3. Must have received no more than 3 lines of systemic therapy for metastatic or unresectable disease, consisting of prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. Neoadjuvant or adjuvant systemic therapy is not counted as a prior line, and standard of care agents need not be repeated in the metastatic setting if not clinically indicated in the opinion of the investigator 4. Body weight ≥40kg	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 1. Serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range and clinically significant in the investigator's judgment 2. Serum creatinine \>1.5 × ULN or creatinine clearance \<60 L/min. 3. Urine dipstick protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h 4. Uncontrolled hypertension, defined as: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management 5. History of arterial thromboembolic events within the past 3 months that are not adequately controlled in the opinion of the investigator 6. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Classification \> Class II), severe or unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of screening 7. Patient has history of or current human immunodeficiency virus (HIV), or hepatitis B infection, even if not active and/or controlled. Prior hepatitis C virus (HCV) infection treated with a full course of curative intent antivirals with an undetectable viral load (below the lower limit of detection) are eligible 8. Use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of study drug and while on study 9. Planned major surgery within 2 weeks prior to study start or during the study

Inclusion Criteria

Exclusion Criteria

1. Males and females ≥18 years of age at the time of consent
2. Willingness and capacity to provide written consent
3. 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.
* 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); sacituzumab govitecan; a checkpoint inhibitor if PD-L1+; a PARPi for patients with gBRCA mutations
* Cutaneous squamous cell carcinoma:
* Must have received prior treatment with a checkpoint inhibitor
* Hormone receptor positive (HR+) breast cancer:
* 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:
* Burkitt lymphoma:
* Must have received at least 2 prior lines of therapy
* Must be ineligible or refuse therapies with demonstrated clinical benefit
* Follicular lymphoma:
* Must have received 3 prior lines of therapy, and must have received rituximab and chemotherapy
4. Patients with solid tumors have measurable disease based on RECIST 1.1. In hematological malignancies LYRIC/Lugano will be used.
5. In defined cohorts, patients must have confirmed positive expression of CD161. Patients must have an available archival biopsy sample or agree to have a fresh biopsy obtained to confirm positivity and must agree to a mandatory newly obtained on-treatment biopsy.
1. Must have histologically or cytologically-documented, unresectable, locally-advanced or metastatic MSS CRC with documented IHC for MMR and/or DNA for MSI consistent with MSS CRC.
2. Eligible for treatment with fruquintinib according to the FDA-approved USPI
3. Must have received no more than 3 lines of systemic therapy for metastatic or unresectable disease, consisting of prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. Neoadjuvant or adjuvant systemic therapy is not counted as a prior line, and standard of care agents need not be repeated in the metastatic setting if not clinically indicated in the opinion of the investigator
4. Body weight ≥40kg

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
1. Serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range and clinically significant in the investigator's judgment
2. Serum creatinine \>1.5 × ULN or creatinine clearance \<60 L/min.
3. Urine dipstick protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h
4. Uncontrolled hypertension, defined as: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management
5. History of arterial thromboembolic events within the past 3 months that are not adequately controlled in the opinion of the investigator
6. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Classification \> Class II), severe or unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of screening
7. Patient has history of or current human immunodeficiency virus (HIV), or hepatitis B infection, even if not active and/or controlled. Prior hepatitis C virus (HCV) infection treated with a full course of curative intent antivirals with an undetectable viral load (below the lower limit of detection) are eligible
8. Use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of study drug and while on study
9. Planned major surgery within 2 weeks prior to study start or during the study

Contacts and Locations

Study Locations (Sites)

Site 9618

Tucson, Arizona, 85711

United States

Site 5000

Denver, Colorado, 80218

United States

Site 4100

Orlando, Florida, 32827

United States

Site 4060

Sarasota, Florida, 34232

United States

Site 4500

Oklahoma City, Oklahoma, 73104

United States

Site 9280

Portland, Oregon, 97239

United States

Site 3000

Nashville, Tennessee, 37203

United States

Site 9384

Austin, Texas, 78705

United States

Site 9112

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Immunitas Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-28

Study Completion Date2026-01

Study Record Updates

Study Start Date2022-11-28

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

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
Follicular Lymphoma

Additional Relevant MeSH Terms

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
Follicular Lymphoma