Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Cetuximab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Arm 1: Dose Escalation Phase: Ascending doses of CGX1321 once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle

Dose Expansion Phase: CGX1321, at the MTD (identified in the Dose Escalation Phase), once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle.

Arm 2: Roll-over Cohort: CGX1321 at a dose identified in Phase 1b, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle).

Arm 2: Phase 1b: Ascending doses of CGX1321, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle).

Arm 3: Phase 1b: Ascending doses of CGX1321, once daily, orally for 3 weeks (21 days) followed by a one-week (7 day) washout period in combination with enocrafenib administered orally once daily and cetuximab administered IV once weekly

CGX1321

encorafenib

cetuximab

Laurie Rosenstein

Amol Rao, M.D.

Sara Keck, M.D.

Wylie Hosmer, M.D.

Jennifer Montcalm

Ben Weinstein, MD

Daniel Kerr, M.D.

Mehdi Moezi, M.D.

Rama Balaraman, M.D.

Petros Nikolinakos, M.D.

Melvin Palalay, M.D.

Marsha Weller

Edward H Kaplan, M.D.

Ebenzer Kio, M.D.

Natraj Ammakkanavar, M.D.

Susan Sartorius-Mergenthaler, RN

Jane Zorzi, RN

Dung Le, MD

Jennifer Rose Stanton, RN

Aparna Parikh, MD

GI Research Line

Marios Giannakis, MD, PhD

Ralph Hauke, M.D.

Steven Papish, M.D.

John Gibbs

John Strickler, MD

Satish Shah, M.D.

Steven Powell, M.D.

Philip Lammers, M.D.

Sibel Blau, M.D.

Lyndsey Deverman

Dustin Deming, M.D.

This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal tumors and CGX1321 in combination with encorafenib + cetuximab in BRAFV600E mutated colorectal tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity.

The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced solid tumors.

The purpose of the Dose Expansion Phase, Roll-over Cohort and Phase 1b is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 alone in subjects with advanced GI tumors (Dose Expansion Phase) and evaluate the safety and tolerability of CGX1321 in combination with pembrolizumab (Phase 1b and Roll-over Cohort) and of CGX1321 in combination with encorafenib + cetuxumab (Phase 1b)

Enrollment to Single Agent Dose Expansion, Roll-over Cohort, Phase 1b CGX1321-101 in combination with pembrolizumab dose expansion and Phase 1b CGX1321 in combination with encorafenib + cetuximab dose escalation and dose expansion

CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)

A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Solid Tumors With Expansion in Advanced Gastrointestinal Tumors and Phase 1b Study of CGX1321 in Combination With Pembrolizumab in Subjects With Advanced Colorectal Cancer or in Combination With Encorafenib + Cetuximab in Subjects With BRAFV600E Mutated Advanced Colorectal Cancer

Merck Sharp & Dohme LLC

Curegenix Inc.

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Carcinoma, Hepatocellular

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Bile Duct Cancer

Dose Escalation Phase: Ascending doses of CGX1321 will be administered by cohort to determine the maximum tolerated dose. Patients will receive CGX1321, once daily, orally, for 3 weeks (21 days) followed by a one week (7 day) washout period in each 28 day cycle, according to the cohort they are assigned.

Dose Expansion Phase: Patients will receive the recommended dose (identified in the Dose Expansion Phase) of CGX1321

Peter Ding

Lin Shen, MD

Jifang Gong

Aiping Zhou, MD

Wen Zhang, MD

This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.

The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced GI tumors that have relapsed or are refractory to or not considered medically suitable to receive standard of care treatment.

Once the dose is identified in the Dose Escalation Phase, the Dose Expansion Phase will start. The purpose of the Dose Expansion Phase is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 when administered to subjects with advanced GI tumors who meet the entry criteria.

Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors

A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors

Guangzhou Curegenix Co. Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)	NCT02675946	Solid Tumors GI Cancer	CGX1321 Pembrolizumab encorafenib cetuximab	18 Years -	Curegenix Inc.
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors	NCT03507998	Colorectal Aden... Gastric Adenoca... Pancreatic Aden... Bile Duct Carci... Hepatocellular ... Esophageal Carc... Gastrointestina...	CGX1321	18 Years -	Curegenix Inc.
CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)	NCT02675946	Solid Tumors GI Cancer	CGX1321 Pembrolizumab encorafenib cetuximab	18 Years -	Curegenix Inc.
CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)	NCT02675946	Solid Tumors GI Cancer	CGX1321 Pembrolizumab encorafenib cetuximab	18 Years -	Curegenix Inc.

Spots Global Cancer Trial Database for cgx1321

Every month we try and update this database with for cgx1321 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cgx1321

Every month we try and update this database with for cgx1321 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cgx1321 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.