Rare Diseases

All Conditions

Lethal Congenital Contracture Syndrome 2

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Mitogens

IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients

U3-1287 (AMG888)

This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.

Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors

A Phase I, Open-label, Dose-Finding Study to Assess the Safety and Tolerability of U3-1287 (AMG 888), a Human Monoclonal Antibody Targeting HER3 in Patients With Advanced Solid Tumors.

U3 Pharma GmbH

Dr Alan Boyd MD

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

MM-141 in combination with nab-paclitaxel and gemcitabine

Placebo in combination with nab-paclitaxel and gemcitabine

MM-141

Placebo

Nab-Paclitaxel

MM-141 Medical Director, MD

The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.

This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status. Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise eligible will be followed in an observational group.

A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

Merrimack Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors	NCT00730470	Advanced Solid ...	U3-1287 (AMG888...	18 Years -	U3 Pharma GmbH
A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer	NCT02399137	Pancreatic Canc...	MM-141 Placebo Gemcitabine Nab-Paclitaxel	18 Years -	Merrimack Pharmaceuticals
Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors	NCT00730470	Advanced Solid ...	U3-1287 (AMG888...	18 Years -	U3 Pharma GmbH

Spots Global Cancer Trial Database for heregulin

Every month we try and update this database with for heregulin 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 heregulin

Every month we try and update this database with for heregulin 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 heregulin 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.