Spots Global Cancer Trial Database for DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT05785754
Conditions
Study Description
Brief Summary: This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11, an anti-CD93 monoclonal antibody, as a monotherapy and in combination in patients with advanced or metastatic solid tumors.
Detailed Description: The drug being tested in this study is called DCSZ11. DCSZ11 is being tested to treat people who have advanced or metastatic solid tumors. The study will include a dose escalation phase and a dose expansion phase. The study will enroll approximately 138 patients in dose escalation, and approximately 113 participants in the dose expansion phase. Participants will receive escalating doses of DCSZ11 and a fixed dose of pembrolizumab until DCSZ11 doses for phase 1b are selected: * Phase 1a DCSZ11 monotherapy Dose Escalation. * Phase 1a DCSZ11 in combination with fixed dose of pembrolizumab Dose Escalation. Once Phase 1b doses are selected for Phase 1b, participants of select advanced or metastatic solid tumors will receive DCSZ11 in below defined cohorts in Phase 1b: * Phase 1b cohort 1 NSCLC. * Phase 1b cohort 2 Microsatellite Stable Colorectal Cancer (MSS-CRC) without liver involvement. * Phase 1b cohort 3 MSS-CRC with liver involvement. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 60 months. Participants will make multiple visits to the clinic, and survival follow-up for a maximum of up to 12 months after the last dose of the study drug.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
Mayo Clinic, Phoenix, Arizona, United States
HonorHealth, Scottsdale, Arizona, United States
University of Colorado, Aurora, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Mayo Clinic, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
MonteFiore, Bronx, New York, United States
Scientia Clinical Research, Randwick, New South Wales, Australia
St Vicent's Hospital, Sydney, New South Wales, Australia
Southern Oncology Clinical Research Unit (SOCRU), Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital (TQEH), Woodville South, South Australia, Australia
Monash Health, Clayton, Victoria, Australia
Cabrini Hospital, Malvern, Victoria, Australia
Linear Clinical Research Limited, Nedlands, Western Australia, Australia
Contact Details
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