Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Blood and Lymph Conditions

Immune System Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Esophageal Neoplasms

Lymphoma

Triple Negative Breast Neoplasms

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Hodgkin Disease

Lymphoma, B-Cell

Burkitt Lymphoma

Colorectal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Squamous Cell

Lymphoma, Non-Hodgkin

Head and Neck Neoplasms

Esophageal Diseases

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Esophageal Cancer

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Hodgkin Lymphoma

Small Intestine Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Hormones

Immunoglobulins

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.

Participants will receive an assigned dose level of IMT-009 in combination with standard of care fruquintinib. Up to 12 Participants will be enrolled in the Phase 1b portion of the study

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

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

IMT-009

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

Fruquintinib

Immunitas Therapeutics

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

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

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

Clearance is the volume of plasma cleared of IMT-009 by the body per unit time.

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Neuroendocrine Tumors

Fibromatosis, Aggressive

Adrenocortical Carcinoma

Pancreatic Cancer

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Desmoid Tumor

Gastrointestinal Agents

Pancrelipase

Pancreatin

Participants will receive E7386 10, 15, 20 mg (milligram) or more, tablets, orally, twice daily, in 28-days treatment cycle until disease progression (PD), development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.

Participants will receive E7386, tablets, orally, twice daily in 28-days treatment cycle until PD, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program. The highest dose of E7386 which is deemed tolerable, or the optimal dose based on PK or PD analysis in dose escalation part will be used for Expansion Part 1.

Participants will receive E7386, tablets, orally, twice daily in 28-days treatment cycle until PD, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program. The dose of Expansion Part 2 will be based on the available safety data from Dose Escalation and Expansion Part 1 of the study.

E7386

The primary objective of this study is to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.

The study will be conducted in 3 parts: dose escalation part, expansion part 1 and expansion part 2. The study will include Pre-treatment Phase, Treatment Phase, and Extension Phase (in expansion parts only).

Eligible participants from Pre-Treatment Phase (screening period) will enter into the Treatment Phase to receive E7386. After Treatment Phase, participants will be followed in follow-up period of Extension Phase (in expansion parts only).

A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)

An Open-label Phase 1 Study of E7386 in Subjects With Advanced Solid Tumor Including Colorectal Cancer

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

DLT will be defined as any of the events that are considered by the investigator to be at least possibly related to therapy with the study medication. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

BOR is defined as complete response (CR), partial response (PR), stable disease (SD), PD, and not evaluable (NE), where SD has to be achieved at greater than or equal to (\>=) 7 weeks after the first dose. The BOR will be assessed by investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

The ORR is defined as the percentage of participants with a BOR of CR or PR. The ORR will be assessed by investigator based on RECIST version 1.1.

DCR is defined as the percentage of participants with a BOR of CR, PR, or SD. The DCR will be assessed by investigator based on RECIST version 1.1.

The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD (duration of SD \>=23 weeks). The CBR will be assessed by investigator based on RECIST version 1.1.

PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed PD or death, whichever occurs first.

DOR is defined as the time from the first date of documented CR or PR to the date of PD or death, whichever occurs first. It will be calculated for participants whose BOR is CR or PR. DOR will be assessed according to RECIST version 1.1.

OS is defined as the time from the date of first dose to the date of death.

Eisai Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas	NCT05565417	Non Small Cell ... Head and Neck S... Triple Negative... Cutaneous Squam... Hormone Recepto... Small Bowel Can... Esophageal Canc... Colorectal Canc... Diffuse Large B... Hodgkin Lymphom... Burkitt Lymphom... Follicular Lymp...	IMT-009 Fruquintinib	18 Years -	Immunitas Therapeutics
A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)	NCT03833700	Solid Neoplasms Colorectal Neop... Gastrointestina...	E7386	18 Years -	Eisai Inc.

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