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.

Micronutrients

Hematinics

Vitamins

Nivolumab

Carboplatin

Pemetrexed

Cisplatin

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

Site 0009

Site 0013

zhiwei chang, Site 0006

Site 0005

Site 0023

Site 0036

Lingfeng Min, Site 0015

Jiuwei Cui, Site 0003

Rui Ma, Site 0004

Site 0021

Site 0037

Site 0030

Zhen Zhou, Site 0001

Site 0034

Site 0033

Jin Zhou, Site 0029

Diansheng Zhong, Site 0007

Dongying Liu, Site 0018

YUNCHAO HUANG, Site 0010

Jianying Zhou, Site 0014

Weimin Mao, Site 0020

Site 0012

Hongcheng Wu, Site 0016

Bristol-Myers Squibb

The purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant pleural mesothelioma.

A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants

A Phase II, Randomized, Open-label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First-line Therapy for Unresectable Pleural Mesothelioma in Chinese Participants

Carcinoma, Bronchogenic

Bronchial Neoplasms

Vinorelbine

Urielle DESALBRES, Director

Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant Pleural Mesothelioma, but all the studies published thus far were based upon a variety of empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modeling showed by simulation that a new metronomic protocol could lead to a better safety and efficacy profile.

Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical Protocol) with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is two-staged as 12 patients are planned to participate in the phase Ia, to confirm safety and consolidate the calibration of the average parameters of the model. Depending the phase Ia result, and after favorable decision of a consultative committee, the extension phase (phase Ib) will be an efficacy study and will include a number of 20 patients receiving the Optimal Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the phase Ia and the objective response according to RECIST 1.1 for the phase Ib.

An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.

Discussion: this ongoing trial is the first to prospectively test a mathematical optimized schedule in metronomic chemotherapy. As such, this trial can be considered as a proof-of-concept study demonstrating the feasibility to run a computational-driven protocol to ensure an optimal efficacy/toxicity balance in patients with cancer.

Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With NSCLC or MPM

Phase IA/IB of Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With Non Small Cell Lung Cancer or Malignant Pleural Mesothelioma

Assistance Publique Hopitaux De Marseille

Antirheumatic Agents

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Following eligibility screening and enrollment, patients will undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMCs), to enable generation of M28z1XXPD1DNR. Following successful M28z1XXPD1DNR CAR T-cell manufacturing, patients will be reevaluated for eligibility. A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m2 will be administered 2-7 days before the infusion. A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. All patients will be monitored in the hospital for a minimum of 48 h following the administration of CAR T cells.

A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m\^2 will be administered 2-7 days before the infusion.

cyclophosphamide

A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. Cohorts of 3 patients will be treated at each dose level, up to a maximum of 3 x 10\^7 T cells/kg or until the MTD has been reached.

CAR T cells

Roisin O'Cearbhaill, MD

Adam Schoenfeld, MD

This study will test the safety of MSLN-targeted CAR-T cells at different doses to find the safest dose to give to people with MPM. The researchers want to see what effects, if any, the study treatment has on people with this type of cancer. This study is the first time that an MSLN-targeted CAR-T cell treatment with an anti-PD1 component is being given to people.

Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma

A Single-Arm, Open-Label, Phase I Trial to Assess the Safety of Genetically Engineered Autologous T Cells Targeting the Cell Surface Antigen Mesothelin With Cell-Intrinsic Checkpoint Inhibition in Patients With Mesothelioma

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

CTCAE v5.0 will be used to assess the severity of all treatment emerging toxicities/adverse events regardless

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 to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese Participants	NCT05136677	Mesothelioma, M...	Nivolumab Ipilimumab Pemetrexed Cisplatin Carboplatin	18 Years -	Bristol-Myers Squibb
Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With NSCLC or MPM	NCT02555007	Non Small Cell ... Malignant Pleur...	Vinorelbine	18 Years -	Assistance Publique Hopitaux De Marseille
Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma	NCT04577326	Malignant Pleur...	cyclophosphamid... CAR T cells	18 Years -	Memorial Sloan Kettering Cancer Center
A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy	NCT02661659	Malignant Pleur...	Multipeptide va...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for malignant pleural mesothelioma (mpm)