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.

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

This study includes only on experimental arm

Cadonilimab + bevacizumab + FOLFOX

Jianmin Xu, PhD

The dual immunotherapy regimen significantly outperformed previous chemotherapy or immunomonotherapy for MSS type advanced CRC in two key efficacy indicators, ORR and PFS. Researchers have also conducted in-depth analysis of patient transcriptomics, immune microenvironment characteristics, and other related information, which is expected to guide more accurate immune combination therapy for CRC in the future. Our team plans to conduct a multicenter, prospective, single arm clinical trial in patients with RAS mutant MSS unresectable metastatic colorectal cancer, with a focus on observing the 1-year progression free survival rate of the combination of two chemotherapy drugs, bevacizumab and Cadonilimab, as well as ORR, perioperative safety, and long-term survival.

Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer

Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer: A Single-Arm, Open-Label, Multicenter Phase II Study

Fudan University

Director, Head of Department of Colorectal Surgery, Principal Investigator, Clinical Professor

Symptoms and General Pathology

Neoplasm Metastasis

Neoplasms, Second Primary

Rectal Neoplasms

Neoplastic Processes

Hematinics

Antibodies

Antibodies, Monoclonal

Capecitabine

Tislelizumab

Immunomodulating Agents

Immunoglobulins

Liver Extracts

In this group, we propose a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis.

Patients will receive tislelizumab in combination with neoadjuvant radiotherapy and chemotherapy, and will be evaluated 2-3 weeks after completion of the treatment. Those patients who achieve complete clinical regression of the lesion can choose observation, but for those without CCR, surgical resection (TME of the primary lesion, surgical resection of metastases or other destructive local treatment) will be applied. Patients will continue to receive tislelizumab for one year after surgery or during observation.

For liver/pulmonary metastasis, the treatment plan is to implement large fraction radiotherapy for 4-8 times. For primary rectum lesion, short-course radiotherapy regimen through intensity-modulated radiotherapy will be applied with dose of 25Gy/5Fx.

Immunotherapy contains anti-PD-1 monoclonal antibody, Tislelizumab(200mg, d1, q3w x6, i.v). Chemotherapy adopts CAPEOX plan, including Capecitabine(1000mg/m2 bid, d1-14, p.o) and oxaliplatin(130mg/m2, d1, i.v).

a combination therapy including tislelizumab

Xinxiang Li, MD

Although patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis could benefit from surgery resection, these patients still have a poorer prognosis compared to those without distal metastasis. Based on previous studies, there is no confirmation of whether these patients could benefit from preoperative immunotherapy combined with conventional chemoradiotherapy. This study proposes a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis, to assess its impact on tumor retreat, decline of postoperative metastasis and recurrence, and the disease-free survival and overall survival of patients. Besides, this study will provide high-level medical evidence for future clinical treatment of patients with advanced rectal cancer.

A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis

Radiotherapy Followed by Chemotherapy and Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Liver/ Pulmonary Metastasis(Miracle-1): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial

rate of no evidence of disease for one year

For patients who still survive when the final analysis takes place, the date of the last 1 contact will be recorded.

DFS refers to the period of time between the date of surgery and the day of the patient's tumor recurrence or death (earliest occurrence).

The date of recurrence is defined as the date on which an objective examination yields a positive result.

Percentage of patients with objective response to primary or metastatic lesions

Surgical excision specimens are taken every 1 cm, and the sections are given to at least 2 pathologists for independent scoring

According to the NCI CTCAE v5.0 assessment, the proportion of patients with treatment-related acute toxicity developed from the beginning of treatment to 90 days after the end of immunotherapy

Professor

Micronutrients

Vitamins

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Trace Elements

Antioxidants

Protective Agents

Tocopherol

Tocotrienol

Patients will be treated with Vitamin E, Fuquinitinib and Tislelizumab.

Vitamin E: 400mg (QD), oral, once daily, continued until disease progression or intolerable toxicity.

Fuquinitinib: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.

Fruquintinib

Tislelizumab: 200mg intravenously every 3 weeks (Q3W), was administered until the occurrence of unacceptable toxic effects, or disease progression, withdrawal of consent, or withdrawal as judged by the investigator.

Dawei Li, PhD

Zhiyu Chen, PhD

The goal of this clinical trial is to learn about efficacy of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.

Dietary supplements are commonly used during conventional cancer treatment. Vitamin E has a variety of functions, including enhancing immunity, anti-inflammation, and anti-oxidation. Tislelizumab is an anti-PD-1 monoclonal antibody, and furoquininib is a tyrosine kinase inhibitor that inhibits tumor angiogenesis. Studies have shown that immunotherapy combined with furoquininib has initial efficacy in the treatment of colorectal cancer. Whether vitamin E combined with immunotherapy and furoquininib can improve the prognosis of patients with colorectal cancer deserves to be studied. Therefore, the objective of this study is to evaluate the efficacy and safety of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy.

Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients

Phase II Clinical Study of Vitamin E Combined With Fruquintinib and Tislelizumab in Patients With Microsatellite Stabilized Metastatic Colorectal Cancer Who Failed Standard Therapy

The proportion of participants whose best outcome is complete remission or partial remission

Time from initiation of treatment to disease progression or death from any cause.

The time between the start of the participants' treatment and their death from any cause

The proportion of patients without disease progression (PD).

Assessment of the safety profile of regimen according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).

Atezolizumab

Azacitidine

Durvalumab

Cc-486

Antimetabolites

Enzyme Inhibitors

Azacitidine will be given by mouth at a fixed dose of 300 mg daily for 14 consecutive days of every 28 day cycle for 3 cycles.

Durvalumab will be given intravenously (by vein) at a fixed dose of 1500 mg (over 1 hour) on Day 1 of every 28 day cycle for 12 months or until disease progression.

Lillian Siu, M.D.

This is a phase 2 study of investigational drug, durvalumab given in combination with azacitidine (CC-486). The main purpose of this phase 2 study is to assess the antitumor activity of azacitidine in combination with durvalumab patients with microsatellite stable colorectal carcinoma (MSS-CRC), platinum resistant epithelial ovarian cancer type II (PR-OC), and estrogen receptor positive and HER2 negative breast cancer.

Study of Azacitidine and Durvalumab in Advanced Solid Tumors

An Open-label, Phase II Basket Study of a hypoMEThylating Agent Oral Azacitidine and DURvalumab (MEDI4736) (Anti-PDL1) in Advanced Solid Tumors (METADUR)

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.
Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer	NCT06218810	Metastatic Colo... Microsatellite ... RAS Mutation Cadonilimab	Cadonilimab + b...	18 Years - 75 Years	Fudan University
A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis	NCT05359393	Advanced Rectal... Liver Metastasi... Pulmonary Metas... Microsatellite ...	a combination t...	18 Years - 75 Years	Fudan University
Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients	NCT05771181	Colorectal Canc... Microsatellite ...	Vitamin E Fruquintinib Tislelizumab	18 Years -	Fudan University
Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients	NCT05771181	Colorectal Canc... Microsatellite ...	Vitamin E Fruquintinib Tislelizumab	18 Years -	Fudan University
Study of Azacitidine and Durvalumab in Advanced Solid Tumors	NCT02811497	Microsatellite ... Platinum Resist... Estrogen Recept...	Azacitidine Durvalumab	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for microsatellite stable colorectal carcinoma