solid tumor
Conditions
Interventions
OBP-301: Intratumoral injection directly into the target region of a tumor at Day 1, Day 15, and Day 29 Dose of OBP-301 in Phase 1a: 1x10^10 (Cohort 1), 1x10^11 (Cohort 2), 1x10^12VP (Cohort 3)(VP:v
max 4 cycles. Pembrolizumab: Administration at a dose of 200 mg/body on Day 8. The administration of Pembrolizumab will be repeated until meeting the discontinuation criteria.
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Be willing and able to provide written informed consent/assent for the trial. 2) Be >=18 years of age on the day of signing the informed consent. 3) Have an ECOG performance status of 0 or 1. 4) Have histologically or cytologically confirmed advanced or metastatic solid tumor with possibility of intratumoral injection, for which no effective standard therapy exists or standard therapy has failed. 5) Have one or more evaluable lesions based on RECIST 1.1 *Evaluable lesions: measurable lesion and/or non-measurable lesion 6) Be willing to provide tissue; newly obtained endoscopic biopsy specimens or formalin-fixed, paraffin-embedded (FFPE) block specimens. 7) Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. It is allowed that the test at the same day at 7 days prior to enrollment. And male / female subjects of childbearing potential must be agree to use an adequate method of contraception starting with signing the informed consent through 120 days after the last dose of study medication. 8) Demonstrated adequate organ function as defined in following criteria. All screening labs should be performed within 7 days of enrollment. It is allowed that the labs at the same day at 7 days prior to enrollment. Note: Subject must not have taken transfusion, hematopoietic agent; G-CSF etc., and/or oxygen inhalation within 7 days before the screening labs. a. Absolute neutrophil count (ANC)>=1,500 /mm3 b. Platelets>=100,000 /mm3 c. Hemoglobin>=9.0 g/dL d. Serum total bilirubin<=2.0 mg/dL e. AST (SGOT) and ALT (SGPT)<=100 IU/L for subjects with liver metastases<=200 IU/L f. Serum creatinine<= 1.5 mg/dL; or if serum creatinine > 1.5 mg/dL, creatinine/clearance >=60 mL/min (Cockroft-Gault formula)
Exclusion criteria
Exclusion criteria: 1) Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of study Day 1. 2) Has an active autoimmune disease that has required systemic treatment in past 2 years. 3) Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study Day 1. 4) Has known active central nervous system metastases and/or carcinomatous meningitis. 5) Has had prior anti-cancer monoclonal antibody chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or immunotherapy targeted to PD-1, PD-L1, PD-L2 within 4 weeks prior to Day 1 or OBP-301 study, who has not recovered from adverse events due to a previously administered agent. 6) Has a known additional malignancy that is progressing or requires active treatment. 7) Has received a live vaccine within 30 days of planned start of study therapy. 8) Has a known history of Human Immunodeficiency Virus. 9) Has known active Hepatitis B or Hepatitis C. 10) Has known history of, or any evidence of active, non-infectious pneumonitis. 11) Has an active infection requiring systemic therapy. 12) Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 13) Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. 14) Previous severe hypersensitivity to another monoclonal antibody 15) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial,interfere with the subject's participation for the full duration of the trial,or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate by the response criteria in solid tumors (RECIST) ver1.1: RR Progression free survival: PFS Rate of adverse event | — |
Countries
Japan
Contacts
Public ContactTakashi Kojima
National Cancer Center Hospital East Department of GI Oncology
Outcome results
None listed