Ireland
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Active, not recruiting Phase 1/2

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

NCT04440735 · tracked via the Priya Life Science USA tracker
Sponsor
Kahr Medical
Phase
Phase 1/2
Started
2020-10-07
Last updated
2025-01-09

Condition(s) studied

Advanced Solid TumorNon Small Cell Lung CancerColorectal Cancer

Investigational drug(s) / intervention(s)

DSP107 →Atezolizumab →

DSP107: DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.

Atezolizumab: Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, 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 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

Primary outcome measure(s)

  • Adverse Events (AEs) — Duration of the study, estimated to be 9 months
    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.
  • Dose Limiting Toxicities (DLT) — At the end of Treatment Cycle 1 (each cycle is 21 days)
    A DLT is defined as a clinically significant AE of laboratory abnormality that is related to DSP107 or the combination of DSP107 and atezolizumab, but is unrelated to disease progression, intercurrent illness or concomitant medications
  • DSP107 Serum Concentration — At the end of Treatment Cycle 8 (each cycle is 21 days)
    Serum samples will be collected to determine circulating levels and PK profile of DSP107

Trial sites (7)

FacilityCityRegionStatus
Moores Cancer Center, UCSD La Jolla California
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP) Aurora Colorado
Florida Cancer Specialists Lake Mary Florida
Indiana University Simon Cancer Center Indianapolis Indiana
KUCC / KUMCRI University of Kansas Cancer Center Kansas City Kansas
SKCC-Sidney Kimmel Cancer Center Thomas Jefferson University Philadelphia Pennsylvania
UPMC Hillman Cancer Center University of Pittsburgh Pittsburgh Pennsylvania
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04440735 on ClinicalTrials.gov ↗ ← All trials in the USA