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.

Adenocarcinoma

Antibodies

Capecitabine

Vinorelbine

Immunomodulating Agents

Antibodies, Bispecific

Immunoglobulins

Tucatinib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

ZW25 administered IV once weekly, once every 2 weeks, or once every 3 weeks. Part 1: in multiple increasing doses; Part 2: ZW25 given at the MTD, OBD, or an RD identified in Part 1; Part 3: ZW25 given at the MTD, OBD, or an RD combined with one of the following selected drug combination:

ZW25 (Zanidatamab)

Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4

Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5

Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6

Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7

Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)

This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).

Part 1 of the study will evaluate increasing doses of ZW25 to find the highest dose of ZW25 that does not cause unacceptable side effects (maximum-tolerated dose or MTD), the lowest safe dose with the highest rate of effectiveness (optimal biological dose or OBD), and/or other recommended dosages (RDs) of ZW25 in up to 7 dose-specific cohorts. Eligible patients include those with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy).

Part 2 of the study will further evaluate the safety, tolerability, and efficacy of ZW25 in patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy) in up to 5 separate disease-specific cohorts.

Part 3 of the study will evaluate the safety, tolerability, and efficacy of ZW25 combined with selected chemotherapy agents, including paclitaxel, capecitabine, vinorelbine, or capecitabine and tucatinib. Patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after at least 1 and no more than 3 prior systemic chemotherapy regimens will be evaluated in this part of the study.

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers

Jazz Pharmaceuticals

Symptoms and General Pathology

Infections

Esophageal Neoplasms

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Microsatellite Instability

Carcinoma, Basal Cell

Skin Neoplasms

Melanoma, Cutaneous Malignant

Carcinoma, Merkel Cell

Fallopian Tube Neoplasms

Endometrial Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neoplasms, Squamous Cell

Uterine Neoplasms

Uterine Diseases

Urologic Neoplasms

Urologic Diseases

Male Urogenital Diseases

Kidney Neoplasms

Kidney Diseases

Fallopian Tube Diseases

Neoplasms, Basal Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Esophageal Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fallopian Tube Cancer

Merkel Cell Carcinoma

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Analgesics

Immune Checkpoint Inhibitors

Pembrolizumab

Interleukin-2

Antineoplastic Agents, Immunological

Analgesics, Non-Narcotic

MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion

MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE).

MDNA11

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.
Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers	NCT02892123	HER2-expressing...	ZW25 (Zanidatam... Paclitaxel Capecitabine Vinorelbine Tucatinib Tucatinib	18 Years -	Jazz Pharmaceuticals
A Beta-only IL-2 ImmunoTherapY Study	NCT05086692	Advanced Solid ... Unresectable So... Clear Cell Rena... Triple Negative... Non-Small Cell ... Non-Small Cell ... Colorectal Canc... Gastric Cancer Cervical Cancer Basal Cell Carc... Bladder Cancer Merkel Cell Car... Squamous Cell C... Cutaneous Squam... Pleural Mesothe... Esophageal Canc... Endometrial Car... Solid Tumor Solid Tumor, Ad... MSI-H Solid Mal... Cancer With A H... Epithelial Ovar... Primary Periton... Gastroesophagea... Acral Melanoma Mucosal Melanom... Cutaneous Melan... DMMR Solid Mali... Fallopian Tube ... Ovarian Cancer MSI-H Cancer DMMR Cancer Pancreas Adenoc... Skin Cancer	MDNA11 Pembrolizumab	18 Years -	Medicenna Therapeutics, Inc.
Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers	NCT02892123	HER2-expressing...	ZW25 (Zanidatam... Paclitaxel Capecitabine Vinorelbine Tucatinib Tucatinib	18 Years -	Jazz Pharmaceuticals
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor	NCT05009966	Advanced Solid ... Gastric Cancer ... Gastroesophagea... Pancreatic Canc...	SYSA1801 for in...	18 Years - 75 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
An Open Label, Single-arm, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of T-Dxd in Combination With Ramucirumab as a 2nd Line in Patients With HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma	NCT05894824	Gastric Cancer Gastroesophagea...	T-Dxd(Trastuzma...	19 Years -	Yonsei University
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor	NCT05009966	Advanced Solid ... Gastric Cancer ... Gastroesophagea... Pancreatic Canc...	SYSA1801 for in...	18 Years - 75 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Spots Global Cancer Trial Database for gastroesophageal junction (gej) cancer