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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name