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Spots Global Cancer Trial Database for A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

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Trial Identification

Brief Title: A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Official Title: An Open-label, Dose Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors

Study ID: NCT04420884

Conditions

Solid Neoplasms

Study Description

Brief Summary: The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

Detailed Description: The drug being tested in this study is called dazostinag. Dazostinag is being tested to treat people who have advanced or metastatic solid tumors. The study will enroll approximately 368 participants. Part 1 consists of an initial Safety Lead-in to Dose Escalation Phase; Part 2 and Part 3 compose the Expansion Phase in 2 specific indications namely, previously untreated metastatic or recurrent, unresectable SCCHN (Part 2) and third-line or later recurrent locally advanced or metastatic MSI-H/dMMR and third-line recurrent locally advanced or metastatic MSS/pMMR CRC (Part 3). Participants will be assigned to the following treatment groups in the respective Phases of the study: * Part 1 (Dose Escalation Phase): Safety Lead-in + Dazostinag single agent (SA) \[Part 1A\] Dazostinag 0.1 milligram (mg) in the Safety Lead-in followed by Dazostinag as escalating doses (0.2 mg and above) in Part 1A * Part 1B (Combination Dose Escalation Phase): Dazostinag as escalating doses (0.2 mg and above) + Pembrolizumab * Japan Safety Lead-in: Dazostinag SA 5.0 mg in the Safety Lead-in+ Pembrolizumab. Additional dose levels of Dazostinag (such as 3.5 mg or 7.0 mg and higher) in combination with pembrolizumab may be explored during the Japan safety lead-in considering recommended dose for expansion (RDE1) as 5.0 mg and dose optimization. Once a safe dose is recommended from Part 1, participants of select advanced or metastatic solid tumors will receive dazostinag in below defined cohorts in the expansion phase: * Part 2A (SCCHN Combined Positive Score \[CPS\] ≥ 1 Dose Expansion Phase): Dazostinag + Pembrolizumab\* * Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy * Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRC * Part 3B (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRC\* \*Dose optimization will be performed in either Part 2A SCCHN or Part 3B CRC. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 62.9 months. Participants will make multiple visits to the clinic, including 30 days after last dose of study drug for a follow-up assessment. Participants in Parts 2 and 3 will be followed for survival for up to 12 months after the last dose of study drug.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of California San Diego Moores Cancer Center, La Jolla, California, United States

Norris Comprehensive Cancer Center, Los Angeles, California, United States

UCI Health - Chao Family Comprehensive Cancer Center, Orange, California, United States

University of California Los Angeles - Jonsson Comprehensive Cancer Center, Santa Monica, California, United States

SCRI - HealthOne Denver, Denver, Colorado, United States

Yale Cancer Center, New Haven, Connecticut, United States

Memorial Cancer Institute at Memorial Hospital West - Cancer Institute/Radiology Oncology, Gainesville, Florida, United States

Orlando Health Cancer Institute, Orlando, Florida, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center, Detroit, Michigan, United States

Siteman Cancer Center - West County, Creve Coeur, Missouri, United States

Siteman Cancer Center - North County, Florissant, Missouri, United States

Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States

Siteman Cancer Center - South County, Saint Louis, Missouri, United States

Siteman Cancer Center - St. Peters, Saint Peters, Missouri, United States

University of Cincinnati Health Barrett Cancer Center, Cincinnati, Ohio, United States

University of Cincinnati Health Barrett Cancer Center, Cincinnati, Ohio, United States

West Chester Hospital, West Chester, Ohio, United States

Providence Portland Medical Center, Portland, Oregon, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, United States

Mary Crowley Cancer Research, Dallas, Texas, United States

Virginia Cancer Specialists, P.C. - Fairfax, Fairfax, Virginia, United States

Klinikum Wels-Grieskirchen, Wels, Oberoesterreich, Austria

Landeskrankenhaus Salzburg, Salzburg, , Austria

Landesklinikum Wiener Neustadt, Wiener Neustadt, , Austria

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven, , Belgium

Cross Cancer Institute, Edmonton, Alberta, Canada

McMaster University Medical Center, Hamilton, Ontario, Canada

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Jewish General Hospital, Montreal, Quebec, Canada

McGill University Health Centre, Montreal, Quebec, Canada

Beijing Cancer Hospital, Beijing, Beijing Sheng, China

Sixth Affiliated Hospital of Sun Yat-Sen University/Guangdong Gastrointestinal Hospital, Guangzhou, Guangzhou Sheng, China

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Shanghai East Hospital, Shanghai, Shanghai, China

West China School of Medicine - West China Hospital of Sichuan University, Chengdu, Sichuan Sheng, China

West China Hospital, Chengdu, Sichuan, China

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Hopital Foch, Suresnes, Ile-de-France, France

Institut de Cancerologie de Lorraine, Vandœuvre-les-Nancy, Meurthe-et-Moselle, France

Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz, Besancon, , France

Hopital Saint-Andre, Bordeaux, , France

Centre Francois Baclesse, Caen, , France

Centre Georges Francois Leclerc, Dijon, , France

Centre de Lutte contre le Cancer - Centre Oscar Lambret, Lille, , France

Centre Leon Berard, Lyon, , France

Hopital de la Timone, Marseille, , France

Hopital Saint-Antoine, Paris, , France

Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau, St Herblain, , France

Gustave Roussy, Villejuif, , France

Soroka Medical Center, Beer Sheva, , Israel

Hadassah University Hospital Ein Kerem, Jerusalem, , Israel

Tel Aviv Sourasky Medical Center, Tel Aviv-Yafo, , Israel

The Chaim Sheba Medical Center, Tel Hashomer, , Israel

National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan

Centrum Onkologii Im. Prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz, Kujawsko-Pomorskie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warsaw, Mazowieckie, Poland

PRCCI Site: Puerto Rico Medical Research Center Torre Medica Hospital Auxilio Mutuo, San Juan, , Puerto Rico

Fundacion de Investigacion de Diego, San Juan, , Puerto Rico

PanOncology Trials: Universidad de Puerto Rico - Centro Comprensivo de Cancer, San Juan, , Puerto Rico

Kantonsspital Sankt Gallen, St. Gallen, Saint Gallen, Switzerland

Inselspital Universitatsspital Bern, Bern, , Switzerland

Hopitaux Universitaires de Geneve, Geneve, , Switzerland

Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, , Switzerland

The Royal Marsden NHS Foundation Trust, Sutton, London, United Kingdom

Queen's University Belfast, Belfast, Northern Ireland, United Kingdom

Leeds Teaching Hospitals NHS Trust, Leeds, , United Kingdom

University College London Hospitals NHS Foundation Trust, London, , United Kingdom

The Royal Marsden NHS Foundation Trust, London, , United Kingdom

Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom

Contact Details

Name: Study Director

Affiliation: Takeda

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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