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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR