A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 9, 2025 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Kahr Medical
- Interventions being studied
- Biological: DSP107; Biological: Atezolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Moores Cancer Center, UCSDLa Jolla, California
- University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)Aurora, Colorado
- Florida Cancer SpecialistsLake Mary, Florida
- Indiana University Simon Cancer CenterIndianapolis, Indiana
- KUCC / KUMCRI University of Kansas Cancer CenterKansas City, Kansas
- SKCC-Sidney Kimmel Cancer Center Thomas Jefferson UniversityPhiladelphia, Pennsylvania
- UPMC Hillman Cancer Center University of PittsburghPittsburgh, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 9, 2025. Always confirm current availability with the study team.