Non Small Cell Lung CancerPhase 1/2NCT05565417
Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
A Phase 1/2 study testing IMT-009 and Fruquintinib in people with Non Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, run by Immunitas Therapeutics at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer
- What is being tested?
- IMT-009 and Fruquintinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Nov 2022to Jan 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1:
- Males and females ≥18 years of age at the time of consent
- Willingness and capacity to provide written 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.
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- 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); 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:
- 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
- Follicular lymphoma:
- Must have received 3 prior lines of therapy, and must have received rituximab and chemotherapy
- Patients with solid tumors have measurable disease based on RECIST 1.1. In hematological malignancies LYRIC/Lugano will be used.
- 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.
- Phase 1B:
- Must meet all of eligibility criteria in Phase 1, AND the following:
- 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.
- Eligible for treatment with fruquintinib according to the FDA-approved USPI
- 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
- Body weight ≥40kg
- Phase 2A:
- Inclusion criteria for these patients will remain similar to those used during Phase 1.
Who cannot join
- 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)
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- 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 1B:
- Must not have met any exclusion criteria for Phase 1, and must not have any of the following:
- Serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range and clinically significant in the investigator's judgment
- Serum creatinine >1.5 × ULN or creatinine clearance <60 L/min.
- Urine dipstick protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h
- Uncontrolled hypertension, defined as: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management
- History of arterial thromboembolic events within the past 3 months that are not adequately controlled in the opinion of the investigator
- 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
- 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
- Use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of study drug and while on study
- Planned major surgery within 2 weeks prior to study start or during the study
- 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 positive tumor demonstrated by the IHC CLIA assay for each analyte.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Site 9384
Austin, Texas, 78705
Site 5000
Denver, Colorado, 80218
Site 9112
Fairfax, Virginia, 22031
Site 3000
Nashville, Tennessee, 37203
Site 4500
Oklahoma City, Oklahoma, 73104
Site 4100
Orlando, Florida, 32827
Site 9280
Portland, Oregon, 97239
Site 4060
Sarasota, Florida, 34232
Site 9618
Tucson, Arizona, 85711
About this study
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
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
Read the 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.
- 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
- Being tested
- IMT-009, Fruquintinib
- 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, Follicular Lymphoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMT-009Drug
Participants will receive an IV infusion of IMT-009 on Day 1 during each 21-day cycle.
FruquintinibCombination product
Also called fruzaqla
Fruquintinib will be administered according to the FDA-approved United States Prescribing Information (USPI).
| Study group | Role | What they receive |
|---|---|---|
| IMT-009 Dose Escalation | Experimental | Participants will receive an assigned dose level of IMT-009 monotherapy in dose escalation. Up to 64 Participants will be enrolled in the Phase 1 portion of the study. Receives: Drug: IMT-009 |
| IMT-009 Phase 1b | Experimental | Participants will receive an assigned dose level of IMT-009 in combination with standard of care fruquintinib. Approximately 18 Participants will be enrolled in the Phase 1b portion of the study. Receives: Drug: IMT-009; Combination Product: Fruquintinib |
| IMT-009 Phase 2a Cohort (s) | Experimental | Each Cohort will evaluate IMT-009 monotherapy in up to 25 Participants Receives: Drug: IMT-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation - number of participants with dose limiting toxicities (DLTs) from IMT-009 monotherapy
Measured: 21 days (Cycle 1 Day 1- Cycle 1 Day 21)
Dose Escalation- Number of participants with adverse events following administration of IMT-009
Measured: From informed consent (Cycle 0 Day -28) to 90 days after the last dose of IMT-009. Each cycle is 21 days
Phase 1b Cohort(s) number of participants with dose limiting toxicities (DLTs) from IMT-009 in combination with fruiquintinib
Measured: 28 days (Cycle 1 Day 1- Cycle 1 Day 28)
Phase 1b Cohort(s) - Number of participants with adverse events following administration of IMT-009 in combination with fruiquintinib
Measured: From informed consent (Cycle 0 Day -28) through 90 days after last dose of IMT-009. Each cycle is 28 days
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
Measured: 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 outcomes (16)
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Area under the plasma concentration-time curve (AUC) of IMT-009 when given as monotherapy or in combination.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Maximum plasma concentration (Cmax) of IMT-009 when given as monotherapy or in combination.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Minimum plasma concentration (Cmin) of IMT-009 when given as monotherapy or in combination.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Volume of distribution (Vd) of IMT-009 when given as monotherapy or in combination.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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 or in combination.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years.Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Terminal half-life (t1/2) of IMT-009 when given as monotherapy or in combination.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Time to maximum plasma concentration (Tmax) of IMT-009 when given as monotherapy or in combination
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Clearance of IMT-009 when given as monotherapy or in combination.
Clearance is the volume of plasma cleared of IMT-009 by the body per unit time.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Number of participants who develop detectable anti-drug antibodies.
Measured: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years.Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE and Phase 1b Cohort(s) - Receptor Occupancy (RO) to determine the target engagement of IMT-009.
Measured: Cycle 1 Day 1 to treatment discontinuation, up to 2 years. Dose Escalation and PDE cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE and Phase 1b Cohort(s) - Overall Response Rate (ORR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess anti-tumor activity of IMT-009.
Measured: 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. Dose Escalation and PDE cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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.
Measured: 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. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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.
Measured: 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. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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.
Measured: 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. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Overall survival (OS) to assess preliminary anti-tumor activity of IMT-009.
Measured: Cycle 1 Day to discontinuation of study drug, then every 3 months for up to 2 years.
Phase 2a Cohort(s)- Number of participants with adverse events following administration of IMT-009.
Measured: From informed consent (Cycle 0 Day -28) to 30 days after the last dose of IMT-009. Each cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start28 Nov 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunitas Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565417
- Sponsor's protocol ID
- IMT-009-101
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2022
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05565417
- Acronym / sponsor ID
- IMT-009-101
- 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
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Immunitas TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMT-009 Dose Escalation | Experimental | Drug: IMT-009Participants will receive an assigned dose level of IMT-009 monotherapy in dose escalation. Up to 64 Participants will be enrolled in the Phase 1 portion of the study. |
| IMT-009 Phase 1b | Experimental | Drug: IMT-009, Combination Product: FruquintinibParticipants will receive an assigned dose level of IMT-009 in combination with standard of care fruquintinib. Approximately 18 Participants will be enrolled in the Phase 1b portion of the study. |
| IMT-009 Phase 2a Cohort (s) | Experimental | Drug: IMT-009Each Cohort will evaluate IMT-009 monotherapy in up to 25 Participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Males and females ≥18 years of age at the time of consent
- Willingness and capacity to provide written 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 with solid tumors have measurable disease based on RECIST 1.1. In hematological malignancies LYRIC/Lugano will be used.
- 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.
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMT-009Participants will receive an IV infusion of IMT-009 on Day 1 during each 21-day cycle. | Drug | IMT-009 Dose Escalation, IMT-009 Phase 1b, IMT-009 Phase 2a Cohort (s) |
| FruquintinibAlso: fruzaqlaFruquintinib will be administered according to the FDA-approved United States Prescribing Information (USPI). | Combination product | IMT-009 Phase 1b |
Primary outcome
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)
Dose Escalation- Number of participants with adverse events following administration of IMT-009
Time frame: From informed consent (Cycle 0 Day -28) to 90 days after the last dose of IMT-009. Each cycle is 21 days
Phase 1b Cohort(s) number of participants with dose limiting toxicities (DLTs) from IMT-009 in combination with fruiquintinib
Time frame: 28 days (Cycle 1 Day 1- Cycle 1 Day 28)
Phase 1b Cohort(s) - Number of participants with adverse events following administration of IMT-009 in combination with fruiquintinib
Time frame: From informed consent (Cycle 0 Day -28) through 90 days after last dose of IMT-009. Each cycle is 28 days
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.
16 secondary outcomes
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Area under the plasma concentration-time curve (AUC) of IMT-009 when given as monotherapy or in combination.
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Maximum plasma concentration (Cmax) of IMT-009 when given as monotherapy or in combination.
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Minimum plasma concentration (Cmin) of IMT-009 when given as monotherapy or in combination.
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Volume of distribution (Vd) of IMT-009 when given as monotherapy or in combination.
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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 or in combination.
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years.Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Terminal half-life (t1/2) of IMT-009 when given as monotherapy or in combination.
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Time to maximum plasma concentration (Tmax) of IMT-009 when given as monotherapy or in combination
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Clearance of IMT-009 when given as monotherapy or in combination.
Time frame: Cycle 1 Day 1 to 90 days after treatment discontinuation, up to 2 years. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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.Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE and Phase 1b Cohort(s) - Receptor Occupancy (RO) to determine the target engagement of IMT-009.
Time frame: Cycle 1 Day 1 to treatment discontinuation, up to 2 years. Dose Escalation and PDE cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE and Phase 1b Cohort(s) - 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. Dose Escalation and PDE cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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. Dose Escalation, PDE and Phase 2a cycles are 21 days. Phase 1b cycles are 28 days.
Dose Escalation, PDE, Phase 1b 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMT-009 and Fruquintinib in people with Non Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, run by Immunitas Therapeutics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 45 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.