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

NCT05565417 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IMT-009-101
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 9

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

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

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

Outcome Measures

Primary Outcomes (5)

• Dose Escalation - number of participants with dose limiting toxicities (DLTs) from IMT-009 monotherapy

  21 days (Cycle 1 Day 1- Cycle 1 Day 21)

• Dose Escalation- Number of participants with adverse events following administration of IMT-009

  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

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

Study Arms (3)

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.

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.

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

Drug: IMT-009

Interventions

IMT-009 DRUG

Participants will receive an IV infusion of IMT-009 on Day 1 during each 21-day cycle.

IMT-009 Dose Escalation; IMT-009 Phase 1b; IMT-009 Phase 2a Cohort (s)

Fruquintinib COMBINATION_PRODUCT

Fruquintinib will be administered according to the FDA-approved United States Prescribing Information (USPI).

Also known as: fruzaqla

IMT-009 Phase 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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:
• 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

Sponsors & Collaborators

• Immunitas Therapeutics: lead

Study Sites (9)

Site 9618

Tucson, Arizona, 85711, United States

Location

Site 5000

Denver, Colorado, 80218, United States

Location

Site 4100

Orlando, Florida, 32827, United States

Location

Site 4060

Sarasota, Florida, 34232, United States

Location

Site 4500

Oklahoma City, Oklahoma, 73104, United States

Location

Site 9280

Portland, Oregon, 97239, United States

Location

Site 3000

Nashville, Tennessee, 37203, United States

Location

Site 9384

Austin, Texas, 78705, United States

Location

Site 9112

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

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; Lymphoma, Follicular; Lymphoma

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 4, 2022
• Study Start: November 28, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)