Advanced Solid TumorPhase 1NCT03172819
Special Combination of OBP-301 and Pembrolizumab
A Phase 1 study testing OBP-301 and Pembrolizumab in people with Advanced Solid Tumor, run by Toshihiko Doi at 1 site in Japan.
Trial summary
This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- OBP-301 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2017to 6 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent/assent for the trial.
- Be >=18 years of age on the day of signing the informed consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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.
- Have one or more evaluable lesions based on RECIST 1.1
- Evaluable lesions: measurable lesion and/or non-measurable lesion
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- Be willing to provide tissue; newly obtained endoscopic biopsy specimens or formalin-fixed, paraffin-embedded (FFPE) block specimens.
- 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.
- 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 7days prior to enrollment.
- Note: Subject must not have taken transfusion, hematopoietic agent; granulocyte-colony stimulating factor (G-CSF) etc., and/or oxygen inhalation within 7 days before the screening labs.
- Absolute neutrophil count (ANC)>=1,500 /mm3
- Platelets>=100,000 /mm3
- Hemoglobin>=9.0 g/dL
- Serum total bilirubin<=2.0 mg/dL
- aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT)<=100 IU/L for subjects with liver metastases<=200 IU/L
- Serum creatinine<= 1.5 mg/dL; or if serum creatinine > 1.5 mg/dL, creatinine/clearance >=60 mL/min (Cockcroft-Gault formula)
Who cannot join
- 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.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- 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.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- 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 Programmed cell death 1 (PD-1), PD-L1, PD-L2 within 4 weeks prior to Da y 1 or OBP-301 study, who has not recovered from adverse events due to a previously administered agent.
- Has a known additional malignancy that is progressing or requires active treatment.
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- Has received a live vaccine within 30 days of planned start of study therapy.
- Has a known history of Human Immunodeficiency Virus.
- Has known active Hepatitis B or Hepatitis C.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 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.
- Previous severe hypersensitivity to another monoclonal antibody
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 With Pembrolizumab in Patients With Advanced Solid Tumors
This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.
Read the detailed description
Phase 1a part:
To evaluate safety and tolerability in combination of OBP-301 and Pembrolizumab in patient with advanced or metastatic solid tumor and to determine recommended dose in phase 1b part.
Phase 1b part:
To evaluate safety and potential efficacy in combination of OBP-301 and Pembrolizumab in patients in expanded arm.
- Conditions
- Advanced Solid Tumor
- Being tested
- OBP-301, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBP-301Biological
Intratumoral injection directly into the dose target region of a tumor at Day 1, Day 15, and Day 29.
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.
PembrolizumabDrug
200 mg Pembrolizumab is infused intravenously at Day 8. Thereafter infusion will continue every 3 weeks until discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| OBP-301+Pembrolizumab | Experimental | OBP-301+Pembrolizumab Receives: Biological: OBP-301; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Dose limiting toxicity
Measured: 4weeks
Secondary outcomes (3)
Response rate (RR)
Response rate by RECIST ver. 1.1
Measured: 3 years
Progression free survival (PFS)
Progression free survival
Measured: 3 years
Rate of adverse event
Rate of adverse event
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Oct 2017
- Primary completion6 Apr 2021
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toshihiko Doi
- Sponsor type
- University, hospital or other
- Collaborators
- Oncolys BioPharma Inc, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Toshihiko Doi, National Cancer Center Hospital East
- Investigators
- Toshihiko Doi, Dr, Study chair, National Cancer Center Hospital East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172819
- Sponsor's protocol ID
- EPOC1505
- Status last verified
- Sep 2022
- First submitted
- 30 May 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 With Pembrolizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03172819
- Acronym / sponsor ID
- EPOC1505
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Toshihiko DoiUniversity, hospital or other
- Collaborators
- Oncolys BioPharma Inc, Merck Sharp & Dohme LLC
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.
Detailed description
Phase 1a part:
To evaluate safety and tolerability in combination of OBP-301 and Pembrolizumab in patient with advanced or metastatic solid tumor and to determine recommended dose in phase 1b part.
Phase 1b part:
To evaluate safety and potential efficacy in combination of OBP-301 and Pembrolizumab in patients in expanded arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OBP-301+Pembrolizumab | Experimental | Biological: OBP-301, Drug: PembrolizumabOBP-301+Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Be willing and able to provide written informed consent/assent for the trial.
- Be >=18 years of age on the day of signing the informed consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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.
- Have one or more evaluable lesions based on RECIST 1.1
Key exclusion criteria (15 listed)
- 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.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- 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.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- 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 Programmed cell death 1 (PD-1), PD-L1, PD-L2 within 4 weeks prior to Da y 1 or OBP-301 study, who has not recovered from adverse events due to a previously administered agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBP-301Intratumoral injection directly into the dose target region of a tumor at Day 1, Day 15, and Day 29. 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. | Biological | OBP-301+Pembrolizumab |
| Pembrolizumab200 mg Pembrolizumab is infused intravenously at Day 8. Thereafter infusion will continue every 3 weeks until discontinuation. | Drug | OBP-301+Pembrolizumab |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 4weeks
Dose limiting toxicity
3 secondary outcomes
Response rate (RR)
Time frame: 3 years
Progression free survival (PFS)
Time frame: 3 years
Rate of adverse event
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshihiko Doi, Dr study chair
National Cancer Center Hospital East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OBP-301 and Pembrolizumab in people with Advanced Solid Tumor, run by Toshihiko Doi at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.