Clinical Trial: NCT04440735 - My Cancer Genome

NCT04440735

Description:

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 single agent treatment and DSP107 in combination with atezolizumab in second line treatment of non small cell lung cancer

Related Conditions:

Malignant Solid Tumor
Non-Small Cell Lung Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04440735

Trial Eligibility

Document

Title

Brief Title: A Study of DSP107 Alone and in Combination With Atezolizumab for Patients With Advanced Solid Tumors
Official Title: 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)

Clinical Trial IDs

ORG STUDY ID: DSP107_001
NCT ID: NCT04440735

Conditions

Advanced Solid Tumor
Non Small Cell Lung Cancer

Interventions

Drug	Synonyms	Arms
DSP107		DSP107 in combination with atezolizumab
Atezolizumab		DSP107 in combination with atezolizumab

Purpose

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 a single expansion cohort consisting of two treatment arms in which
      subjects will be treated either with DSP107 monotherapy or DSP107 in combination with
      atezolizumab. This part of the study will enrol subjects with non small cell lung cancer who
      have progressed following first line treatment with PD-1 or PD-L1 targeting agents having
      previously achieved a best response of stable disease or better.

Trial Arms

Name	Type	Description	Interventions
DSP107 monotherapy	Experimental	DSP107 will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. The study will include up to 12 treatment cycles. Starting dose will be 0.01 mg/kg and maximum dose will not exceed 10 mg/kg.	DSP107
DSP107 in combination with atezolizumab	Experimental	DSP107 will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion.	DSP107 Atezolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Subject must have measurable disease per RECIST version 1.1

          -  Part 1:

             o Histologically confirmed advanced solid tumor that is not amenable to surgical
             resection or other approved therapeutic options that have demonstrated clinical
             benefit or subject is intolerant or has refused available therapies

          -  Part 2:

               -  Histologically confirmed, inoperable non-small cell lung cancer (Stage 3b or
                  Stage 4)

               -  Squamous and non-squamous histologies are both acceptable

               -  Wildtype for actionable oncogenic driver mutations

               -  Received first line treatment including anti PD-1 or anti PD-L1 therapeutic agent
                  ± chemotherapy and achieved a best response of stable disease measured after 12
                  weeks of treatment

        Exclusion Criteria:

          -  Life expectancy of ≤ 3 months

          -  Central nervous system (CNS) metastases

          -  Life-threatening (grade 4) immune-mediated adverse event related to prior
             immunotherapy

          -  Immune-mediated adverse reaction that required discontinuation of prior immunotherapy

          -  Past or current history of autoimmune disease or immune deficiency

          -  History of autoimmune hemolytic anemia or autoimmune thrombocytopenia

          -  History of hematological malignancy

          -  History of organ or stem cell transplantation

          -  Clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty
             liver disease and inherited liver disease

          -  Previously treatment with CAR-T cells

          -  Treatment with systemic immunosuppressive medication within 2 weeks prior to first
             dose of study treatment

          -  Received live, attenuated vaccine within 4 weeks prior to first dose of study
             treatment

          -  Treatment with systemic immunostimulatory agents within 4 weeks prior to first dose of
             study treatment

          -  Treatment with atezolizumab, any CD47/SIRPα targeting agent or immune agonists (e.g.,
             anti-CD137, anti-CD40, anti-OX40)

          -  Known allergy or hypersensitivity to any of the test compounds, materials or
             contraindication to test product

          -  Clinically significant abnormal laboratory safety tests

          -  Detection of anti DSP107 antibodies at screening

          -  History of HIV infection or active Hepatitis B or C infection

          -  Pregnant or breast feeding or planning to become pregnant while enrolled in the study

          -  History or evidence of any other clinically unstable/uncontrolled disorder, condition,
             or disease

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Adverse Events (AEs)
Time Frame:	Duration of the study, estimated to be 9 months
Safety Issue:
Description:	An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Secondary Outcome Measures

Measure:	DSP107 Effect on Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells
Time Frame:	At the end of Treatment Cycle 8 (each cycle is 21 days)
Safety Issue:
Description:	Blood samples will be collected and examined by flow cytometry to determine the effect of DSP107 on different T-cells, B-cells, NK cells and monocytes, and their expression of activation markers.

Measure:	DSP107 and atezolizumab anti-drug antibody (ADA) formation
Time Frame:	Duration of the study, estimated to be 9 months
Safety Issue:
Description:	Serum samples will be collected throughout the study for assessment of ADA formation using validated assay.

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Kahr Medical

Last Updated

May 26, 2021

Clinical Trials /

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