Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors (NCT05651022) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors
United States120 participantsStarted 2023-02-28
Plain-language summary
INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females, age 18 years or older.
✓. Histologically confirmed diagnosis of locally advanced or metastatic solid tumor. For Part 2, subjects must have one of the following locally advanced or metastatic tumor types: hepatocellular carcinoma (HCC), colorectal cancer (CRC) with liver metastasis, urothelial cancer, squamous cell carcinoma of the head and neck (SCCHN), adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC), dMMR/MSI-High tumor (Part 2c only).
✓. Subject must have exhausted all available therapy or have declined treatment or treatment is contraindicated. Subjects with tumors that have known actionable molecular alteration such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on directed molecular therapy. For Part 2c, participants with a tumor type for which a CPI has been approved must have received a CPI during one or more lines of therapy.
✓. Measurable disease (at least 1 measurable lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as defined by tumor type.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Life expectancy of at least 3 months.
✓. Female subjects must be of non-childbearing potential (surgically sterile or at least 2 years postmenopausal) or agree to use a highly effective contraception method while receiving treatment with Decoy20 and for 30 days after the last dose of Decoy20.
✓. Male subjects must utilize reliable contraceptive precautions for the duration of Decoy20 treatment and 30 days after the last dose of Decoy20.
Exclusion criteria
What they're measuring
1
Number of Subjects with dose-limiting toxicities (DLTs)
Timeframe: Through study completion, up to 3 years
✕. Has an active systemic (viral, bacterial, or fungal) infection or requiring treatment.
✕. Received radiotherapy within 28 days of the first dose of Decoy20. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
✕. Received prior chemotherapy, targeted therapy or immunotherapy within 28 days or 5 half-lives from W1D1, whichever is shorter.
✕. Received systemic corticosteroid therapy \> 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) from the start of study drug or is expected to require it during the course of the study (topical and inhaled steroids are permitted).
✕. Has radiographically detected primary central nervous system (CNS) metastases or symptomatic CNS involvement (including leptomeningeal carcinomatosis, cranial neuropathies or mass lesions that cause spinal cord compression). Participants with brain metastases (either treated or deemed unnecessary to treat) that have been stable by neuroimaging for at least 4 weeks will be eligible.
✕. Clinical evidence of significant coagulopathy during Screening (e.g., deep vein thrombosis or pulmonary embolism) or history of significant uncontrolled coagulopathy (participants with HCC must have prothrombin time (PT) \< 4 seconds above ULN or international normalized ratio \[INR\] \< 1.7) or participants with diagnosis of a new thrombotic event within 90 days prior to Decoy20 dosing.
✕. Has an active secondary malignancy in addition to the primary, excluding low-risk neoplasms as determined by the Investigator (e.g., non-metastatic basal cell or squamous cell skin carcinoma) and other indolent malignancies will be allowed after discussion with the Sponsor).