Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT04440735
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, 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04440735
Study Brief:
Protocol Section:
NCT04440735