About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
2. Subject must have measurable disease per RECIST version 1.1
3. 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
4. Part 2, Expansion Cohort A:
5. Histologically confirmed, inoperable non-small cell lung cancer (Stage 3b or Stage 4). Squamous and non-squamous histologies are both acceptable
6. Wildtype for actionable oncogenic driver mutations (e.g., ALK, EGFR, ROS1, RET, NTRK). Driver mutations for KRAS, BRAF and c-METex14skip will be allowed.
7. 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.
8. Part 2, Expansion Cohort B:
9. Histologically confirmed, inoperable microsatellite stable colorectal carcinoma (Stage 3b or Stage 4)
10. Received two previous lines of therapy including standard chemotherapy and/or targeted antibodies

Exclusion criteria

1. Life expectancy of ≤ 3 months
2. Central nervous system (CNS) metastases
3. Life-threatening (grade 4) immune-mediated adverse event related to prior immunotherapy
4. Immune-mediated adverse reaction that required discontinuation of prior immunotherapy
5. Past or current history of autoimmune disease or immune deficiency
6. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
7. History of hematological malignancy
8. History of organ or stem cell transplantation
9. Clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease and inherited liver disease
10. Previously treatment with CAR-T cells
11. Treatment with systemic immunosuppressive medication within 2 weeks prior to first dose of study treatment
12. Received live, attenuated vaccine within 4 weeks prior to first dose of study treatment
13. Treatment with systemic immunostimulatory agents within 4 weeks prior to first dose of study treatment
14. Treatment with atezolizumab, any CD47/SIRPα targeting agent or immune agonists (e.g., anti-CD137, anti-CD40, anti-OX40)
15. Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product
16. Clinically significant abnormal laboratory safety tests
17. Detection of anti DSP107 antibodies at screening
18. History of HIV infection or active Hepatitis B or C infection
19. Pregnant or breast feeding or planning to become pregnant while enrolled in the study
20. History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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