Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Prostatic Neoplasms

Stomach Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Transitional Cell

Lymphoma, Large B-Cell, Diffuse

Mesothelioma

Mesothelioma, Malignant

Lymphoma, B-Cell

Squamous Cell Carcinoma of Head and Neck

Colorectal Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Skin Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Lymphoma, Non-Hodgkin

Breast Diseases

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Head and Neck Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Lymphosarcoma

Transitional Cell Carcinoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Malignant Mesothelioma

Richter Syndrome

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Paclitaxel

Irinotecan

Albumin-Bound Paclitaxel

Oxaliplatin

Taxane

Tubulin Modulators

Antimitotic Agents

Multiple dose levels and dosing regimen of NX-1607 to be evaluated; determination of MTD/Phase 1b recommended dose.

Impact of food on NX-1607 bioavailability and tolerability to be evaluated

Patients with platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma

Patients with recurrent, locally advanced, or metastatic gastric or GEJ adenocarcinoma

Patients with recurrent, locally advanced, or metastatic HNSCC

Patients with recurrent and either metastatic or unresectable Melanoma

Patients with Stage IV adenocarcinoma NSCLC

Patients with mCRPC who received a minimum of 2 prior lines of therapy in the advanced setting including androgen receptor-directed therapy and a taxane-based chemotherapy and has PSA or radiographic progression

Cohort of mixed solid tumor indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or DLBCL/DLBCL-RT

Patients with DLBCL or DLBCL-RT, previously treated with standard, systemic chemotherapy, are not candidates for standard treatment options, or will otherwise be prevented from receiving any standard treatment options.

Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer. HSNCC, NSCLC, TNBC, locally advanced or metastatic urothelial cancer and cervical cancer.

Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer, HSNCC, NSCLC, TNBC, and locally advanced or metastatic urothelial cancer

Patients with histologically confirmed MSS CRC, known KRAS WT, and must have been previously treated with \> 2 lines of systemic therapy including a fluoropyrimidine, irinotecan, and/or oxaliplatin (and EGFR inhibitor if known Ras wild type)

NX-1607

Nurix Therapeutics Patient Outreach

Dr. Villaflor

Xiomara Menendez

Lorraine Martinez

Early Phase Clinical Trials

Brandi Asheim

Wells Messersmith, MD

Clinical Trials Office

Christina Caldwell

Rabia Khan

Magnifique Irakoze

Laiken Lopez

Swathi Namburi, MD

UCLH Research

Ruth Orr

Referrals

The Christie Enquiries

Paula O'Connor, MD

This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.

Phase 1a will consist of 2 study arms: Monotherapy and Paclitaxel combo. Phase 1a dose escalation will evaluate the safety and tolerability of NX-1607 in adult patients with advanced solid tumors for which standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. Indications for monotherapy include platinum resistant epithelial ovarian cancer (EOC), gastric/gastroesophageal junction (GEJ) cancer, squamous cell carcinoma of the head and neck (HNSCC), recurrent and either metastatic or unresectable melanoma, non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (mCRPC), malignant pleural mesothelioma (MPM), triple-negative breast cancer (TNBC), locally advanced or metastatic urothelial cancer, cervical cancer, and microsatellite stable colorectal cancer (MSS CRC), and diffuse large cell B-cell lymphoma (DLBCL) including patients with Richter transformation (DLBCL-RT). Indications for paclitaxel combo may include, but are not limited to, platinum-resistant EOC, gastric/GEJ cancer, HNSCC, NSCLC, TNBC, locally advanced or metastatic urothelial cancer, and cervical cancer at the Sponsor's discretion.

Phase 1b will investigate the efficacy of NX-1607 as monotherapy or in combination with paclitaxel at the dose(s) selected in Phase 1a in up to 8 cohorts of patients with select advanced malignancies for which standard therapy, including immunotherapy, with proven clinical benefit does not exist, is no longer effective, or is not appropriate. Indications include platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma, advanced gastric/GEJ cancer, HNSCC, recurrent and either metastatic or unresectable melanoma, advanced NSCLC, mCRPC, mixed solid tumor cohort indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or MSS CRC, and DLBCL including patients with DLBCL-RT.

A Study of NX-1607 in Adults With Advanced Malignancies

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment

Nurix Therapeutics, Inc.

Carcinoma, Hepatocellular

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Neuroendocrine Tumor

Neuroepithelioma

Lenvatinib

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive E7386 twice daily (BID) along with pembrolizumab 200 mg intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day treatment cycle until RP2D is determined in Phase 1b. The recommended dose for Phase 2 part of the study will be based on Phase 1b result. Participants will continue to receive study treatment in Phase 2 part until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study.

Participants will be randomized to receive E7386 Dose 1 (Cohort 1) or Dose 2 (Cohort 2) tablet, BID, orally in combination with pembrolizumab 200 mg Q3W IV infusion plus lenvatinib 8 mg capsule, orally, once daily (QD) continuously in 21-days treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study. The dose of treatment depends on tolerability data of both Cohorts.

E7386

Eisai Medical Information

The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab.

The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer \[CRC\], hepatocellular carcinoma \[HCC\]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

An Open-Label, Multicenter, Phase 1b/2 Study of E7386 in Combination With Pembrolizumab in Previously Treated Subjects With Selected Solid Tumors

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

DLTs are any pre-specified toxicities occurring during Cycle 1, based on investigator assessment as related to study drug. All adverse events (AEs) of the specified grades should count as DLTs except those that are clearly and incontrovertibly due to disease progression or extraneous causes. DLTs will be assessed to determine the RP2D of E7386 in combination with pembrolizumab. All toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

BOR is defined as CR, PR, stable disease (SD), PD, and not evaluable (NE), where SD has to be achieved at greater than equal to (\>=) 5 weeks after the first dose per RECIST version 1.1.

DOR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death due to any causes, whichever occurs first in participants with confirmed CR or PR as per RECIST version 1.1.

DCR is defined as the percentage of participants with BOR of confirmed CR, PR, or SD after \>=5 weeks from first dose per RECIST version 1.1.

CBR is defined as the percentage of participants who have a BOR of confirmed CR, PR, or durable SD (duration of SD \>=23 weeks) per RECIST 1.1.

DLTs are any pre-specified toxicities occurring during Cycle 1, based on investigator assessment as related to study drug. All AEs of the specified grades should count as DLTs except those that are clearly and incontrovertibly due to disease progression or extraneous causes. All toxicity will be graded using NCI CTCAE version 5.0.

Merck Sharp & Dohme LLC

Eisai Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of NX-1607 in Adults With Advanced Malignancies	NCT05107674	Ovarian Cancer,... Gastric Cancer GastroEsophagea... Head and Neck S... Metastatic or U... Non-small Cell ... Metastatic Cast... Malignant Pleur... Triple Negative... Metastatic Urot... Cervical Cancer Diffuse Large B... Richter Transfo... Microsatellite ...	NX-1607 Paclitaxel	18 Years -	Nurix Therapeutics, Inc.
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors	NCT05091346	Melanoma Carcinoma, Hepa... Colorectal Neop...	E7386 Pembrolizumab Lenvatinib	18 Years -	Eisai Inc.

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