Clinical trial · Interventional
A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors
A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-escalation Safety Study (part 1) and Preliminary Efficacy Assessment of DSP107 As Monotherapy and in Combination with Atezolizumab (part 2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Biological | Atezolizumab | ALIAS |
| DSP107 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- DSP107 monotherapy in advanced solid tumors
- description
- DSP107 will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle for up to 12 treatment cycles. Starting dose will be 0.01 mg/kg and maximum dose will not exceed 10 mg/kg.
- interventionNames
- Biological: DSP107
- type
- EXPERIMENTAL
- label
- DSP107 in combination with atezolizumab in advanced solid tumors
- description
- DSP107 will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.
- interventionNames
- Biological: DSP107
- Biological: Atezolizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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