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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000026961 |
Receipt No. | R000030917 |
Scientific Title | An Open label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 with Pembrolizumab in Patients with advanced solid tumors. |
Date of disclosure of the study information | 2017/07/31 |
Last modified on | 2020/04/14 |
Basic information | ||
Public title | An Open label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 with Pembrolizumab in Patients with advanced solid tumors. | |
Acronym | OBP+Pem | |
Scientific Title | An Open label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 with Pembrolizumab in Patients with advanced solid tumors. | |
Scientific Title:Acronym | OBP+Pem | |
Region |
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Condition | |||
Condition | solid tumor | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Phase 1a part: To evaluate safety and tolerability of the combination of OBP-301 and Pembrolizumab in patients with advanced or metastatic solid tumor and to determine the recommended dose in phase 1b part.
Phase 1b part: To evaluate safety and potential efficacy of the combination of OBP-301 and Pembrolizumab in patients in expanded arm. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | Dose limiting toxicity (DLT) |
Key secondary outcomes | Response rate by the response criteria in solid tumors (RECIST) ver1.1: RR
Progression free survival: PFS Rate of adverse event |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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:virus particle) Additional administration of OBP-301 After the recommended dose of OBP-301 has been established, additional administration of OBP-301 is allowed. After completion of administration of OBP-301 on Day 1 - Day 29(+/- 4 days), if the target region has not disappeared, additional administration of OBP-301 is allowed after Day 43 or later. The patients in Phase 1a, Pembrolizumab administration has continued, are included. The recommended dose determined in the Phase 1a part will be administered 3 times biweekly (+/- 4 days); 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. |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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) |
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Key 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. |
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Target sample size | 38 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital East | ||||||
Division name | Department of Experimental Therapeutics | ||||||
Zip code | 277-8577 | ||||||
Address | 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan | ||||||
TEL | 04-7133-1111 | ||||||
OBPem_core@east.ncc.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Cancer Center Hospital East | ||||||
Division name | Department of GI Oncology | ||||||
Zip code | 277-8577 | ||||||
Address | 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan | ||||||
TEL | 04-7133-1111 | ||||||
Homepage URL | |||||||
OBPem_core@east.ncc.go.jp |
Sponsor | |
Institute | National Cancer Center Hospital East
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Institute | |
Department |
Funding Source | |
Organization | Oncolys BioPharma Inc. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) | Project of Translational and Clinical Research Core Centers |
IRB Contact (For public release) | |
Organization | National Cancer Center Hospital Institutional Review Board |
Address | Tsukiji 5-1-1, Chuo-ku, Tokyo |
Tel | 04-7133-1111 |
irboffice@east.ncc.go.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 岡山大学病院(岡山県)、国立がん研究センター東病院(千葉県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030917 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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