A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
DSP107: DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
Atezolizumab: Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1
Study 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.
Eligibility
Primary outcome measure(s)
- Adverse Events (AEs) — Duration of the study, estimated to be 9 months
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. - Dose Limiting Toxicities (DLT) — At the end of Treatment Cycle 1 (each cycle is 21 days)
A DLT is defined as a clinically significant AE of laboratory abnormality that is related to DSP107 or the combination of DSP107 and atezolizumab, but is unrelated to disease progression, intercurrent illness or concomitant medications - DSP107 Serum Concentration — At the end of Treatment Cycle 8 (each cycle is 21 days)
Serum samples will be collected to determine circulating levels and PK profile of DSP107
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Moores Cancer Center, UCSD | La Jolla | California | |
| University of Colorado Hospital, Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | |
| Florida Cancer Specialists | Lake Mary | Florida | |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | |
| KUCC / KUMCRI University of Kansas Cancer Center | Kansas City | Kansas | |
| SKCC-Sidney Kimmel Cancer Center Thomas Jefferson University | Philadelphia | Pennsylvania | |
| UPMC Hillman Cancer Center University of Pittsburgh | Pittsburgh | Pennsylvania |
On this site
📄 Tecentriq (atezolizumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04440735 on ClinicalTrials.gov ↗ ← All trials in the USA