Locally Advanced or Metastatic Pancreatic CancerPhase 1/2NCT03579836
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
A Phase 1/2 study testing BEY1107 and Gemcitabine in people with Locally Advanced or Metastatic Pancreatic Cancer, run by BeyondBio Inc. at 1 site in South Korea.
Trial summary
This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Locally Advanced or Metastatic Pancreatic Cancer
- What is being tested?
- BEY1107 and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2018to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- At lease one measurable lesion according to RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
- Over 12 weeks of Life expectancy
- Adequate Bone marrow, Renal and Liver function at screening
Who cannot join
- A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
- Major surgery history at screening
- Uncontrolled brain metastasis evidence
- Active bacterial infection patients
- Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
- expected Pregnant or breast-feeding patients
- HIV, Active hepatitis B or C infection
- A patient who has hypersensitivity with BEY1107 or Gemcitabine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System Severance Hospital
Seoul
About this study
Official title: A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination with Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer
This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.
Read the detailed description
The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD.
Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial.
At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial.
Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial.
Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.
- Being tested
- BEY1107, Gemcitabine
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEY1107Drug
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.
GemcitabineCombination product
Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.
| Study group | Role | What they receive |
|---|---|---|
| Phase I-1 (#4 Cohort) | Experimental | BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) Receives: Drug: BEY1107 |
| Phase I-2 (#3 Cohort) | Experimental | BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) Receives: Drug: BEY1107; Combination Product: Gemcitabine |
| Phase II (#1 Cohort) | Experimental | BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off) Receives: Drug: BEY1107; Combination Product: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD & Safety assessment (Phase I)
Measured: 0
DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)
Measured: 0
Secondary outcomes (5)
AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Measured: 0
Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Measured: 0
DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Measured: 0
ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)
Measured: 0
Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start14 May 2018
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Pancreatic CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeyondBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579836
- Sponsor's protocol ID
- BEY-2018-01
- Status last verified
- Mar 2025
- First submitted
- 8 Jun 2018
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination with Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03579836
- Acronym / sponsor ID
- BEY-2018-01
- Keywords
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- BeyondBio Inc.Industry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jul 2018 (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 study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.
Detailed description
The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD.
Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial.
At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial.
Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial.
Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I-1 (#4 Cohort) | Experimental | Drug: BEY1107BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) |
| Phase I-2 (#3 Cohort) | Experimental | Drug: BEY1107, Combination Product: GemcitabineBEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off) |
| Phase II (#1 Cohort) | Experimental | Drug: BEY1107, Combination Product: GemcitabineBEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- At lease one measurable lesion according to RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
- Over 12 weeks of Life expectancy
- Adequate Bone marrow, Renal and Liver function at screening
Key exclusion criteria (8 listed)
- A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
- Major surgery history at screening
- Uncontrolled brain metastasis evidence
- Active bacterial infection patients
- Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
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 |
|---|---|---|
| BEY1107Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule. | Drug | Phase I-1 (#4 Cohort), Phase I-2 (#3 Cohort), Phase II (#1 Cohort) |
| GemcitabineAdminister 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule. | Combination product | Phase I-2 (#3 Cohort), Phase II (#1 Cohort) |
Primary outcome
MTD & Safety assessment (Phase I)
Time frame: 0
DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II)
Time frame: 0
5 secondary outcomes
AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Time frame: 0
Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Time frame: 0
DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I)
Time frame: 0
ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II)
Time frame: 0
Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II)
Time frame: 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BEY1107 and Gemcitabine in people with Locally Advanced or Metastatic Pancreatic Cancer, run by BeyondBio Inc. at 1 site in South Korea.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. 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 South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BeyondBio Inc. (+82-42-716-0020, clinicaltrials@beyondbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD & Safety assessment (Phase I) (time frame: 0). The study lists 2 primary outcomes in all. 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 10 Mar 2025.