SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas (NCT03894618) | Clinical Trial Compass
CompletedPhase 1
SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas
United States, Belgium, Canada49 participantsStarted 2019-03-26
Plain-language summary
This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
✓. Subject has a histologically confirmed diagnosis of one of the following unresectable locally advanced or metastatic malignancies: melanoma, non-small cell lung cancer (squamous, adeno, or adeno-squamous), urothelial cancer, squamous cell carcinoma of the head and neck, squamous cell cervical cancer, gastric or gastro-esophageal junction adenocarcinoma, squamous cell carcinoma of the anal canal, squamous cell carcinoma of the skin, renal cell cancer, Hodgkin's lymphoma, and microsatellite instability high (MSI-H) or mismatch repair deficient (MMRD) solid tumors excluding CNS malignancies. MSI and MMRD testing results as per institution is acceptable.
✓. Subject must have received, been intolerant to, or is ineligible for standard therapy (per local guidelines and approvals) or have a malignancy for which there is no approved therapy considered standard of care.
✓. Age 18 years and older.
✓. Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
✓. Has measurable disease by iRECIST (solid tumors) or RECIL 2017 (lymphoma). Refer to Appendix Sections 16.6 and 16.7 for details on criteria of measurable disease.
✓. Has life expectancy of greater than 12 weeks.
✓. Laboratory values must meet the following criteria. Laboratory parameter Threshold value
Exclusion criteria
✕. Has received more than two prior checkpoint inhibitor containing treatment regimens (regimen refers to either monotherapy or combination immunotherapies) or has had prior treatment with an OX40 agonist.
What they're measuring
1
Safety Profile of SL-279252
Timeframe: From Day 1 to 90 days after Last Dose of SL-279252
2
Maximum Tolerated Dose (MTD) of SL-279252
Timeframe: From Day 1 to Day 21 (Schedule 1) or Day 28 (Schedule 2)
✕. Refractory to last PD-1/L1 inhibitor-based therapy which is defined as disease progression within 3 months of treatment initiation.
✕. Any anti-cancer therapy within the time intervals noted below prior to first dose (D1) of SL-279252.
✕. Concurrent chemotherapy, immunotherapy, biologic or hormonal therapy is prohibited. Concurrent use of hormones for non-cancer related conditions is acceptable.
✕. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of D1 of IP with the following exceptions (i.e., the following are allowed during treatment with or within14 days of D1 of IP):
✕. Receipt of live attenuated vaccine within 28 days of D1 of IP.
✕. Active or documented history of autoimmune disease (autoimmune disease does not refer to irAEs; for irAEs see inclusion criteria #11). Exceptions include Type I diabetes, vitiligo, alopecia areata or hypo/hyperthyroidism.
✕. Active pneumonitis (i.e. drug-induced, idiopathic pulmonary fibrosis, radiation-induced, etc.).