NCT04440735

A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors

A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-escalation Safety Study (part 1) and Preliminary Efficacy Assessment of DSP107 As Monotherapy and in Combination with Atezolizumab (part 2)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Kahr Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be the first time that DSP107 is administered to human subjects. The aim of the study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DSP107 monotherapy and combination therapy in a two-part design. Part 1 will involve DSP107 monotherapy dose escalation in subjects with advanced solid tumors that are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. Additional dose finding cohorts will be enrolled to establish a safe dose of DSP107 when given in combination with atezolizumab. Part 2 will comprise two expansion cohorts: A) Expansion cohort A consisting of one treatment arm in which subjects will be treated with DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with non small cell lung cancer who have progressed following no more than 2 lines of prior systemic treatment including treatment with PD-1 or PD-L1 targeting agents. B) Expansion cohort B consisting of two treatment arms in which subjects will be treated either with DSP107 monotherapy or DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with colorectal cancer who have progressed following two previous lines of therapy.

Conditions

• Advanced Solid Tumor
• Non Small Cell Lung Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DSP107	DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
BIOLOGICAL	Atezolizumab	Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1

Timeline

• Start date: 2020-10-07
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2020-06-22
• Last updated: 2025-01-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study