Study of SRF617 in Patients With Advanced Solid Tumours

Official Title

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

Summary:

A Phase 1, first-in-human, SRF617 monotherapy and combination therapy, dose escalation, safety, and tumour biopsy expansion study of SRF617, an antibody that inhibits CD39 activity, in patients with advanced solid tumours. Inhibition of CD39 activity may improve the ability to mount an immune response against tumour cells.

Trial Description

Primary Outcome:

• Dose Limiting Toxicity of SRF617

Secondary Outcome:

• Safety Analysis: Summary of adverse events (AEs) and based on treatment-emergent AEs (TEAEs)
• Pharmacokinetics (PK) of SRF617
• Pharmacodynamics of SRF617
• Objective response rate (ORR)
• Duration of response (DoR)
• Disease control rate (DCR)
• Progression-free survival (PFS)
• Landmark PFS rate
• Effect of SRF617 on intratumoural CD39 enzymatic activity

A Phase 1, open-label, first-in-human, SRF617 monotherapy and combination therapy dose escalation, safety, and tumour biopsy expansion study in patients with advanced solid tumours. The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as monotherapy in patients with advanced solid tumours. The monotherapy tumour biopsy expansion portion of the study will further evaluate the safety and intratumoural 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 tumours.

View this trial on ClinicalTrials.gov