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.

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Follicular Lymphoma

Marginal Zone Lymphoma

Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], marginal zone lymphoma \[MZL\], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day.

Participants with relapsed/refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) will receive BGB-21447 once a day.

Participants will receive BGB-21447 with up to two dose levels from Cohort A1 for further evaluation of safety and efficacy.

BGB-21447

BeiGene

This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminstered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion."

A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies

Number of participants with dose limiting toxicities, defined as \[see text in SAP or protocol for specific definition\]

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

TLS will be determined via laboratory values and assessed by the investigator.

In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death.

defined as the percentage of patients who achieve partial response or better for diffuse large B-cell lymphoma, marginal zone lymphoma, follicular lymphoma, transformed B-NHL, and Richter's transformation to DLBCL as per the Lugano Classification for non-Hodgkin lymphoma

defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death due to any cause, whichever occurs first.

defined as the time from treatment initiation to the first documentation of response.

defined as the time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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 BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies	NCT05828589	Relapsed Non-Ho... Refractory Non-... Relapsed Chroni... Refractory Chro... Relapsed Follic... Relapsed Margin... Relapse Diffuse... Relapsed Small ... Refractory Foll... Refractory Marg... Refractory Smal... Richter Transfo... Refractory Diff... Transformed Non...	BGB-21447	18 Years -	BeiGene
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies	NCT05828589	Relapsed Non-Ho... Refractory Non-... Relapsed Chroni... Refractory Chro... Relapsed Follic... Relapsed Margin... Relapse Diffuse... Relapsed Small ... Refractory Foll... Refractory Marg... Refractory Smal... Richter Transfo... Refractory Diff... Transformed Non...	BGB-21447	18 Years -	BeiGene

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