Spots Global Cancer Trial Database for A Study of DSP107 Alone and in Combination With Atezolizumab for Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of DSP107 Alone and in Combination With Atezolizumab for Patients With Advanced Solid Tumors
Official Title: A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects With Advanced Solid Tumors Including a Dose-escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination With Atezolizumab (Part 2)
Study ID: NCT04440735
Study Description
Brief Summary: Part 1: A first-in-human, open-label, Phase I dose escalation study of DSP107 monotherapy and combination therapy with atezolizumab in patients with advanced solid tumors. Part 2: Preliminary efficacy assessment of DSP107 in combination with atezolizumab in second or third line treatment of non small cell lung cancer. Preliminary efficacy assessment of DSP107 as a single agent or in combination with atezolizumab in third line treatment of colorectal cancer.
Detailed Description: This study will be the first time that DSP107 is administered to human subjects. The aim of the study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DSP107 monotherapy and combination therapy in a two-part design. Part 1 will involve DSP107 monotherapy dose escalation in subjects with advanced solid tumors that are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. Additional dose finding cohorts will be enrolled to establish a safe dose of DSP107 when given in combination with atezolizumab. Part 2 will comprise two expansion cohorts: A) Expansion cohort A consisting of one treatment arm in which subjects will be treated with DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with non small cell lung cancer who have progressed following no more than 2 lines of prior systemic treatment including treatment with PD-1 or PD-L1 targeting agents. B) Expansion cohort B consisting of two treatment arms in which subjects will be treated either with DSP107 monotherapy or DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with colorectal cancer who have progressed following two previous lines of therapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moores Cancer Center, UCSD, La Jolla, California, United States
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States
Florida Cancer Specialists, Lake Mary, Florida, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
KUCC / KUMCRI University of Kansas Cancer Center, Kansas City, Kansas, United States
SKCC-Sidney Kimmel Cancer Center Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Contact Details
Name: Jason Luke, MD
Affiliation: University of Pittsburgh
Role: PRINCIPAL_INVESTIGATOR
Name: Anwaar Saeed, MD
Affiliation: University of Pittsburgh
Role: PRINCIPAL_INVESTIGATOR
Name: Jun Zhang, MD
Affiliation: KUMC
Role: PRINCIPAL_INVESTIGATOR
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