Spots Global Cancer Trial Database for Study of SRF617 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: Study of SRF617 in Patients With Advanced Solid Tumors
Official Title: A Phase 1 Study of SRF617 in Patients With Advanced Solid Tumors
Study ID: NCT04336098
Conditions
Study Description
Brief Summary: A Phase 1, first-in-human, monotherapy and combination dose escalation and expansion study of SRF617.
Detailed Description: A Phase 1, open-label, first-in-human, study of SRF617, consisting of a monotherapy dose escalation, a monotherapy tumor biopsy expansion, combination dose escalations, and combination safety and efficacy expansions that will enroll patients with advanced solid tumors. The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SRF617 as monotherapy in patients with advanced solid tumors. The monotherapy tumor biopsy expansion portion of the study will further evaluate the safety and intratumoral pharmacodynamics of SRF617 monotherapy. The combination therapy dose escalation portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel, or SRF617 in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors. Once the SRF617 combination recommended Phase 2 doses are established, additional patients with select solid tumors may be enrolled in the respective combination expansion arm of the study. An additional quadruplet combination will also be explored in patients with advanced first line (1L) PDAC (i.e., SRF617 + pembrolizumab + gemcitabine + albumin-bound paclitaxel).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
University of Colorado, Aurora, Colorado, United States
Moffitt Cancer Center, Tampa, Florida, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
University of Washington, Seattle, Washington, United States
University Health Network-Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame, Montréal, Quebec, Canada
Contact Details
Name: Alison O'Neill, MD
Affiliation: Surface Oncology
Role: STUDY_CHAIR
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