UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026961 |
|---|---|
| Receipt number | 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 | 2022/01/24 09:02:41 |
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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
| Japan |
Condition
Condition
solid tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
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
| Medicine |
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.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
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)
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.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Doi |
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
| 1st name | Takashi |
| Middle name | |
| Last name | Kojima |
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 or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
| 2017 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030917
