Gastric CancerPhase 2NCT04768686

FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer

A Phase 2 study testing FLX475 and Pembrolizumab in people with Gastric Cancer, run by Hanmi Pharmaceutical Company Limited at 10 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastric Cancer
What is being tested?: FLX475 and Pembrolizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 10 sitesSouth Korea
Study dates: 18 May 2021to 12 Aug 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma
Patient must have one of the following diagnoses to be eligible for enrollment into cohorts:
Cohort 1: Checkpoint inhibitor naïve Epstein-Barr Virus negative (EBV-) gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer
Cohort 2: Checkpoint inhibitor naïve Epstein-Barr virus positive (EBV+) gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Patient must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI)
Tumor available for biopsy

Who cannot join

Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), any history of discontinuing from that treatment due to Grade 3 or higher immune-related adverse event (irAE)
Patient with MSI-H status
Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or clinical symptoms of active pneumonitis
Significant cardiovascular disease. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or chronic Grade 3 hypertension.
Significant screening electrocardiogram (ECG) abnormalities
Has had an allogenic tissue/solid organ transplant

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

South Korea10 sites

Hanllym University Medical Center
Anyang-si, Gyeonggi-do
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do

Other trials in South Korea

About this study

Official title: A Phase 2 Study to Assess the Safety, Efficacy of FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer

This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. This study is designed to assess the potential anti-tumor activity when administered at the 100mg QD of FLX475 with pembrolizumab and will be conducted (2) cohorts as detailed below.

Cohort 1: EBV negative / CPI naïve gastric cancer subjects who have progressed on at least 2 prior systemic treatments for advanced or metastatic gastric cancer
Cohort 2: EBV positive / CPI naïve gastric cancer subjects who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.

Conditions: Gastric Cancer
Being tested: FLX475, Pembrolizumab
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLX475Drug
tablet
PembrolizumabDrug
Also called KEYTRUDA®
IV infusion

Study groups in NCT04768686
Study group	Role	What they receive
FLX475 and pembrolizumab combination therapy	Experimental	* Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer * Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer Receives: Drug: FLX475; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
The primary efficacy endpoint is Objective Response Rate (ORR) defined as the proportion of subjects whose confirmed best overall response is either Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1. For the efficacy endpoints (such as ORR and DCR), frequency and percentage of subjects who have achieved a response will be summarized by cohort and 95% 2-sided confidence interval will be calculated by Clopper-Pearson method.
Measured: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.

Secondary outcomes (5)

Disease Control Rate (DCR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
The Disease Control Rate (DCR) is defined as the proportion of subjects with confirmed best overall response of CR, PR or SD according to RECIST version 1.1.
Measured: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Time to Response (TTR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
The Time to Response (TTR) is defined as the time from the date of first administration of study treatment to first documented Complete Response (CR) or Partial Response (PR).
Measured: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Duration of Response (DoR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
The Duration of Response (DoR) is measured from the date of the first observation of tumor response (Complete Response (CR) or Partial Response (PR), whichever occurs first) to the date of disease progression or death for the subject with an objected response.
Measured: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Progression-free Survival (PFS) in Subjects Treated With FLX475 in Combination With Pembrolizumab
The Progression-free Survival (PFS) is defined as the time from the date of first administration of study treatment to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first.
Measured: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Overall Survival (OS) in Subjects Treated With FLX475 in Combination With Pembrolizumab
The Overall Survival (OS) is defined as the duration of time from the treatment start date to time to death from any cause. If subjects survive at the time of analysis, the subject will be censored at the last date of survival confirmed.
Measured: From baseline (Cycle 1 Day 1 prior to administration of the first study dose) until death from any cause.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202112 Aug 2024

First posted24 Feb 2021
Study start18 May 2021
Primary completion12 Aug 2024
Study completion12 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04768686
Sponsor's protocol ID: HM-CCRI-201
Other IDs: KEYNOTE-B83, MK-3475-B83
Status last verified: Sep 2025
First submitted: 22 Feb 2021
Last updated: 25 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastric Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study to Assess the Safety, Efficacy of FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer
ClinicalTrials.gov ID: NCT04768686
Acronym / sponsor ID: HM-CCRI-201
Conditions: Gastric Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Merck Sharp & Dohme LLC
Study start: 18 May 2021 (actual)
Primary completion: 12 Aug 2024 (actual)
Study completion: 12 Aug 2024 (actual)
First posted: 24 Feb 2021 (actual)
Results: Posted 25 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Cohort 1: EBV negative / CPI naïve gastric cancer subjects who have progressed on at least 2 prior systemic treatments for advanced or metastatic gastric cancer
Cohort 2: EBV positive / CPI naïve gastric cancer subjects who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FLX475 and pembrolizumab combination therapy	Experimental	Drug: FLX475, Drug: Pembrolizumab* Cohort 1: EBV negative / CPI naïve gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer * Cohort 2: EBV positive / CPI naïve gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma
Patient must have one of the following diagnoses to be eligible for enrollment into cohorts:
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Patient must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI)
Tumor available for biopsy

Key exclusion criteria (7 listed)

Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), any history of discontinuing from that treatment due to Grade 3 or higher immune-related adverse event (irAE)
Patient with MSI-H status
Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or clinical symptoms of active pneumonitis
Significant cardiovascular disease. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or chronic Grade 3 hypertension.

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
FLX475tablet	Drug	FLX475 and pembrolizumab combination therapy
PembrolizumabAlso: KEYTRUDA®IV infusion	Drug	FLX475 and pembrolizumab combination therapy

Primary outcome

Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
Time frame: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
The primary efficacy endpoint is Objective Response Rate (ORR) defined as the proportion of subjects whose confirmed best overall response is either Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1. For the efficacy endpoints (such as ORR and DCR), frequency and percentage of subjects who have achieved a response will be summarized by cohort and 95% 2-sided confidence interval will be calculated by Clopper-Pearson method.

5 secondary outcomes

Disease Control Rate (DCR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
Time frame: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Time to Response (TTR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
Time frame: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Duration of Response (DoR) in Subjects Treated With FLX475 in Combination With Pembrolizumab
Time frame: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Progression-free Survival (PFS) in Subjects Treated With FLX475 in Combination With Pembrolizumab
Time frame: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.
Overall Survival (OS) in Subjects Treated With FLX475 in Combination With Pembrolizumab
Time frame: From baseline (Cycle 1 Day 1 prior to administration of the first study dose) until death from any cause.

Results and safety

Results posted to the registry on 25 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLX475 and Pembrolizumab Combination Therapy	20	20

Primary outcome: Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab

Time frame: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1: EBV Negative / CPI naïve Gastric Cancer n = 10	Cohort 2: EBV Positive / CPI naïve Gastric Cancer n = 10
Value	0 (0 to 30.8)	60.0 (26.2 to 87.8)

Population analysed: The treated set included all subjects who received at least 1 dose of FLX475 or pembrolizumab. All demographics, Baseline characteristics, efficacy and safety data were analyzed using the Treated Set as a primary analysis population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent Adverse Events were recorded and followed through 30 days following cessation of study treatment (or 30 days after final dose if new anticancer therapy initiates), or until resolution, whichever comes first, up to 27 months. All Serious Adverse Events (SAEs) were reported after the consent form is signed through 90 days following cessation of study treatment, or 30 days after final dose if the subject initiates new anticancer therapy, whichever occurs first, up to 27 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: EBV Negative / CPI naïve Gastric Cancer	2 of 10 (20%)	9 of 10 (90%)	3 of 10
Cohort 2: EBV Positive / CPI naïve Gastric Cancer	5 of 10 (50%)	10 of 10 (100%)	4 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FLX475 and Pembrolizumab in people with Gastric Cancer, run by Hanmi Pharmaceutical Company Limited at 10 sites 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 7 inclusion and 7 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (ORR) in Subjects Treated With FLX475 in Combination With Pembrolizumab (time frame: Initial assessment performed after the first 2 cycles, then every 2 cycles for the first year, followed by every 3 cycles thereafter for up to 2 years and at any time per investigator's discretion and at ED/EOT, up to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04768686.

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 25 Sep 2025.