Study of SRF617 in Patients With Advanced Solid Tumors

Status Completed

Clinical Trial Summary

A Phase 1, first-in-human, monotherapy and combination dose escalation and expansion study of SRF617.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04336098
Study type	Interventional
Source	Coherus Biosciences, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	March 16, 2020
Completion date	August 25, 2023

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