Trials / Completed
CompletedNCT03512340
Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers
A Phase 1 Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Surface Oncology · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and hematological cancers. Part B will include monotherapy expansion cohorts in advanced solid and hematologic cancers to further examine SRF231 as monotherapy (100 patients total).
Detailed description
This first-in-human study is designed to evaluate the safety and tolerability of SRF231 as a monotherapy via dose escalation (Part A), and to determine the dose(s) of SRF231 to be further examined in expansion cohorts as monotherapy. The preliminary clinical activity of SRF231 administered as monotherapy will be characterized, along with pharmacokinetics (PK) and pharmacodynamics. In Part B, the safety and tolerability of SRF231 as monotherapy will be evaluated in select patient cohorts of advanced cancers and evaluate clinical activity. The study also is designed to examine the effect of SRF231 monotherapy on peripheral blood immune cell subsets, peripheral blood gene expression, and serum biomarkers
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SRF231 | SRF231 specifically blocks the interaction between CD47 and signal regulatory protein alpha and acts as a potent enhancer of human tumor cell phagocytosis. |
Timeline
- Start date
- 2018-03-13
- Primary completion
- 2020-09-15
- Completion
- 2020-09-29
- First posted
- 2018-04-30
- Last updated
- 2020-10-20
Locations
3 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03512340. Inclusion in this directory is not an endorsement.