SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas

Inclusion Criteria

Participants are eligible to be included in the study only if all the following criteria apply.

• 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.
• Head and neck cancers: Subjects must have primary tumor locations in the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor sites of nasopharynx, maxillary sinus, paranasal, and unknown primary are excluded.
• Non-small cell lung cancers: Subjects with a known EGFR sensitizing (activating) mutation or an ALK fusion are excluded.
• 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
• Absolute lymphocyte count (ALC) ≥ 0.8 x 109/liter (L)
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support
• Platelet count ≥ 50 x 109/L

Laboratory parameter Threshold value

• Hemoglobin (Hgb) > 9.0 g/dL with no blood transfusions for at least 5 days prior to D1 of investigational product (IP; SL-279252)
• Creatinine clearance (CrCl) ≥ 30 milliliter (mL)/min (modified Cockcroft-Gault)
• ALT/AST ≤ 3 x ULN
• Total bilirubin ≤ 1.5 x ULN; subjects with isolated indirect hyperbilirubinemia are permitted if direct bilirubin ratio is 2 weeks prior to D1 of IP and no longer require steroids.
• Women who are breast feeding.
• Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.
• Another malignancy that requires active therapy and that in the opinion of the investigator and Sponsor would interfere with monitoring of radiologic assessments of response to IP.
• Has undergone allogeneic stem cell transplantation or organ transplantation.
• Known history or positive test for human immunodeficiency virus, or positive test for hepatitis B (positive for hepatitis B surface antigen [HBsAg]) or hepatitis C virus ([HCV]; if HCV antibody (Ab) test is positive check for HCV ribonucleic acid [RNA]).
• (NOTE: Hepatitis B virus (HBV): Subjects who are hepatitis B core antibody [HBcAb] positive, but HBsAg negative are eligible for enrollment. HCV: Subjects who are HCV Ab positive, but HCV RNA negative are eligible for enrollment).