NCT04336098

Study of SRF617 in Patients With Advanced Solid Tumors

A Phase 1 Study of SRF617 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SRF617	SRF617 prevents CD39 mediated conversion of adenosine triphosphate (ATP) and adenosine diphosphate (ADP) to adenosine monophosphate (AMP) and phosphate, leading to an increase in extracellular ATP and a reduction in adenosine levels within the tumor microenvironment (TME). There is an important role for extracellular ATP and adenosine in cancer maintenance and progression, and maintaining high levels of ATP (and low levels of adenosine) in the TME may have anticancer therapeutic activity.
DRUG	Gemcitabine	Gemcitabine as an intravenous (IV) infusion
DRUG	Albumin-Bound Paclitaxel	Albumin-bound paclitaxel as an IV infusion
DRUG	Pembrolizumab	Pembrolizumab as an IV infusion .

Timeline

• Start date: 2020-03-16
• Primary completion: 2023-08-25
• Completion: 2023-08-25
• First posted: 2020-04-07
• Last updated: 2024-06-04

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study