Status:
ACTIVE_NOT_RECRUITING
A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors
Lead Sponsor:
Kahr Medical
Conditions:
Advanced Solid Tumor
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 efficac...
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 o...
Eligibility Criteria
Inclusion
- 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, Expansion Cohort A:
- 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 (e.g., ALK, EGFR, ROS1, RET, NTRK). Driver mutations for KRAS, BRAF and c-METex14skip will be allowed.
- Received no more than 2 lines of prior systemic treatment, including anti PD-1 or anti PD-L1 therapeutic agent ± chemotherapy. Targeted therapies for KRAS, BRAF and c-METex14skip will not be counted towards the previous lines of therapy.
- Part 2, Expansion Cohort B:
- Histologically confirmed, inoperable microsatellite stable colorectal carcinoma (Stage 3b or Stage 4)
- Received two previous lines of therapy including standard chemotherapy and/or targeted antibodies
Exclusion
- 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
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04440735
Start Date
October 7 2020
End Date
September 1 2025
Last Update
January 9 2025
Active Locations (7)
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1
Moores Cancer Center, UCSD
La Jolla, California, United States, 92093
2
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States, 80045
3
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
4
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202