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Gastric CancerPhase 1/2NCT05438459

GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites

A Phase 1/2 study testing GAIA-102, Pembrolizumab and Trifluridine/tipiracil hydrochloride (FTD/TPI) in people with Gastric Cancer and Pancreatic Cancer, run by Kyushu University at 1 site in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Phase I Part : Confirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastric Cancer, Pancreatic Cancer
What is being tested?
GAIA-102, Pembrolizumab and Trifluridine/tipiracil hydrochloride (FTD/TPI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteJapan
Study dates
8 Jun 2022to 31 Mar 2032
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with malignant ascites, as well as unresectable or advanced recurrent pancreatic cancer.
  • Phase I:
  • Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.
  • Phase II:
  • Patients with gastric cancer who have received 2 or more prior chemotherapy regimens, including at least 1 regimen containing an immune checkpoint inhibitor, and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 1 or more prior chemotherapy regimens, including at least 1 regimen containing gemcitabine, and are refractory or intolerant to these therapies.
  • Only patients with HER2-negative gastric cancer are eligible.
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  • Abdominal port placement is possible
  • Phase I:
  • No medical history of serious adverse reactions or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
  • PhaseⅡ(gastric cancer):
  • No medical history of serious adverse reactions or allergic reactions to pembrolizumab or trifluridine/tipiracil hydrochloride (FTD/TPI) ,or to any components of these agents.
  • PhaseⅡ(pancreatic cancer):
  • No medical history of serious adverse reactions or allergic reactions to pembrolizumab, irinotecan hydrochloride hydrate, fluorouracil, or calcium levofolinate hydrate ,or to any components of these agents.
  • Diagnosed gastric adenocarcinoma or pancreatic cancer with by histological or cytological examination
  • The patient has been confirmed to be "negative (not MSS = MSI-high)" by microsatellite instability (MSI) testing, or "proficient mismatch repair (pMMR)" by mismatch repair protein immunohistochemistry testing
  • The Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) at the time of informed consent meets the following conditions.
  • Phase I ：0-2, Phase II ：0-1
  • Patient aged 20years or older
  • Adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function:
  • Neutrophil ≧1,500/mm3, hemoglobin ≧8.0 g/dL, Platelet ≧75,000/mm3, PT-INR≦ 1.5 , AST, ALT≦ 3 times the upper limit of reference value, T-Bil≦ 2 times the upper limit of reference value (T-Bil ≦ 3.0mg/dL , when drainage for obstructive jaundice), eGFR ≧30mL/min/1.73m2
  • Expected to survive for 3 months or more at the enrollment
  • Written informed consent

Who cannot join

  • Untreated cranial metastases.
  • Diagnosed with meningeal carcinomatosis
  • Received allogeneic hematopoietic stem cell transplantation
  • Participated in other clinical trials / clinical trials within 30 days prior to obtaining written consent and used or had used the investigational product or investigational equipment.
  • Existence or suspected active autoimmune disease
  • Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg / day in terms of prednisolone or other immunosuppressants within 14 days prior to investigational product administration
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  • Symptomatic interstitial pneumonia, or even if it is not symptomatic, it may interfere with diagnostic imaging in detecting new pneumonitis caused by the investigational product used in the clinical trial.
  • Have active double cancer and need treatment for the double cancer
  • Requires treatment as shown in "Unacceptable Combination / Supportive Therapy" during the clinical trial period
  • Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment
  • Have one of the following complications Complication of cerebrovascular disorder with symptoms or history within 6 months before the enrollment, Active gastrointestinal perforation, fistula, diverticulitis, Symptomatic congestive heart failure, Bleeding tendency, Presence of blood clots that may cause embolism on the image, Unhealed fractures (excluding compression fractures associated with osteoporosis) or severe wounds requiring medical treatment, Uncontrollable digestive ulcer, Active infectious diseases requiring intravenous administration of antibiotics, antifungal agents or antiviral agents, HIV antibody positive
  • At the time of the enrollment, the period from the following prior treatment or the end of treatment has not passed.
  • Surgery (including exploratory laparotomy / examination laparoscope): 2 weeks, Palliative radiotherapy: 1 week, Thoracic drainage: 1 week, Pretreatment antineoplastic (from the last administration): 3 weeks, Biopsy with incision, thoracic biopsy, treatment for trauma (excluding patients without wound healing), etc : 2 weeks
  • Scheduled thoracotomy or abdominal surgery during the clinical trial period
  • It is judged that it is difficult to enroll in this study due to clinically significant mental illness.
  • Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.
  • Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)
  • Difficult to participate in the trial by the investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eiji Oki contact

+81-92-642-5479

oki.eiji.857@m.kyushu-u.ac.jp

Japan1 site, 1 recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

    Eiji Oki, +81-92-642-5479, oki.eiji.857@m.kyushu-u.ac.jp

    Recruiting

Other trials in Japan

About this study

Official title: Clinical Trial of Repeated Intraperitoneal Administration of GAIA-102 in Patients With Advanced Gastrointestinal Cancer (Gastric Cancer / Pancreatic Cancer) of Microsatellite Stable (MSS) With Malignant Ascites (Phase I / II Investigator-initiated Clinical Trial) (GAIA-102-PD Clinical Trial)

Phase I Part :

Confirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part.

Read more

Phase II Part(Gastric Cancer):Comparative Study Research the efficacy and safety of as a monotherapy or GAIA-102 and pembrolizumab for advanced gastrointestinal cancer of microsatellite stable with malignant ascites at the recommended dose of GAIA-102 decided in the Phase I part.

Phase II Part (Pancreatic Cancer): Comparative Study Including a Run-in Cohort Research the efficacy and safety of a combination regimen of GAIA-102 and pembrolizumab added to existing chemotherapy (standard of care) for microsatellite stable advanced pancreatic cancer with malignant ascites at the recommended dosing frequency of GAIA-102 decided in the Phase I part.

Being tested
GAIA-102, Pembrolizumab, Trifluridine/tipiracil hydrochloride (FTD/TPI), Irinotecan hydrochloride hydrate, Calcium levofolinate hydrate
Medical subject headings
Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • GAIA-102Biological

    GAIA-102: 1 vial (2 x 10^8 cells) as dose at a fixed dose, on 1 to 3 times by weekly for 3 consecutive weeks.

  • GAIA-102Biological

    GAIA-102: 1 vial (2 x 10^8 cells) as dose at a fixed dose, on 3 times by weekly for 3 consecutive weeks.

  • PembrolizumabDrug

    Pembrolizumab 200 mg administered on Day 1.

  • PembrolizumabDrug

    Pembrolizumab 200 mg administered on Day 8.

  • Trifluridine/tipiracil hydrochloride (FTD/TPI)Drug

    Trifluridine/tipiracil hydrochloride (FTD/TPI) will be administered orally twice daily for 5 consecutive days, followed by a 2-day rest period. This cycle will be repeated twice, followed by a 14-day rest period. One course consists of this schedule, and the treatment will be repeated in cycles.

  • Irinotecan hydrochloride hydrateDrug

    Intravenous infusion of 70 mg/m² (based on body surface area) over 90 minutes at 2-week intervals.

  • Calcium levofolinate hydrateDrug

    Intravenous infusion of 200 mg/m² (based on body surface area) over 2 hours.

  • FluorouracilDrug

    Immediately after completion of the calcium levofolinate hydrate intravenous infusion, fluorouracil 400 mg/m² (based on body surface area) will be administered by intravenous injection, followed by a continuous intravenous infusion of fluorouracil 2,400 mg/m² (based on body surface area) over 46 hours.

Study groups in NCT05438459
Study groupRoleWhat they receive
Phase I Monotherapy CohortExperimentalParticipants receive GAIA-102 as monotherapy.
Receives: Biological: GAIA-102
Phase I Combination CohortExperimentalParticipants receive GAIA-102 in combination with pembrolizumab.
Receives: Biological: GAIA-102; Drug: Pembrolizumab
Phase II Gastric Cancer Part: GAIA-102 and Pembrolizumab Combination GroupExperimentalParticipants receive GAIA-102 in combination with pembrolizumab.
Receives: Biological: GAIA-102; Drug: Pembrolizumab
Phase II Gastric Cancer Part: Ttrifluridine/tipiracil hydrochloride (FTD/TPI)Control GroupActive comparatorParticipants receive trifluridine/tipiracil hydrochloride (FTD/TPI).
Receives: Drug: Trifluridine/tipiracil hydrochloride (FTD/TPI)
Phase II Pancreatic Cancer Part:GAIA-102 and Pembrolizumab Added to Standard Therapy GroupExperimentalParticipants receive GAIA-102 in combination with pembrolizumab, irinotecan hydrochloride hydrate, calcium levofolinate hydrate, and fluorouracil.
Receives: Biological: GAIA-102; Drug: Pembrolizumab; Drug: Irinotecan hydrochloride hydrate; Drug: Calcium levofolinate hydrate; Drug: Fluorouracil
Phase II Pancreatic Cancer Part:Standard Therapy GroupActive comparatorParticipants receive standard therapy consisting of irinotecan hydrochloride hydrate, calcium levofolinate hydrate, and fluorouracil.
Receives: Drug: Irinotecan hydrochloride hydrate; Drug: Calcium levofolinate hydrate; Drug: Fluorouracil

What is being measured

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

  1. Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I)

    DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and is defided following events: 1. Grade 4 hemotoxicity or hemotoxicity requiring blood transfusion. 2. Grade 3 or higher non-hematoxicity

    Measured: Cycle 1 (Cycle period is 28 days)

  2. Frequency and severity of adverse events(Phase I)

    Measured: 2 year

  3. Overall survival in patients with gastric cancer (Phase II)

    Measured: up to 4 years

  4. Overall survival in patients with pancreatic cancer (PhaseⅡ)

    Measured: up to 5 years(up to 5.5 years for the Run-in Cohort）

Secondary outcomes (11)

  1. Objective Response Rate （ORR) and Disease Control Rate (DCR)(Phase I)

    Disease control rate based on RECIST version 1.1. DCR is defined as the proportion of participants whose best overall response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) during the first 24 weeks after the initial administration of study treatment. Stable disease is defined as meeting the RECIST v1.1 criteria for SD at least once at any time point 8 weeks or more after study registration.

    Measured: Up to 24 weeks after first dose

  2. Progression-free Survival(Phase I)

    Measured: 2 year

  3. Overall Survival Period(Phase I)

    Measured: 2 year

  4. Pharmacokinetics of GAIA-102(Phase I)

    The following metrics were meassured as pharmcokinetics; Cmax: The peak plasma concentration of a drug after administration.; tmax. : Time to reach Cmax; Cmin: The lowest (trough) concentration that a drug reaches before the next dose is administered.

    Measured: pre-dose

  5. Biomarker of GAIA-102(Phase I)

    Protein expression levels are measured in ascites and blood as biomarkers. The following are the markers to be measured; CCL3/CCL4/CCL5/CCL20/CXCL9/CXCL10/CXCL11

    Measured: pre-dose

  6. Objective Response Rate and Disease Control Rate(Phase II)

    Disease control rate based on RECIST version 1.1. DCR is defined as the proportion of participants whose best overall response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) during the first 24 weeks after the initial administration of study treatment. Stable disease is defined as meeting the RECIST v1.1 criteria for SD at least once at any time point 8 weeks or more after study registration.

    Measured: up to 24 weeks after first dose

  7. Progression-free Survival (Phase II)

    Measured: up to 4 years for patients with gastric cancer and up to 5 years for patients with pancreatic cancer (up to 5.5 years for the Run-in Cohort).

  8. Objective Response Period and Period until Objective Response (Phase II)

    Measured: up to 2 years

  9. One-year survival rate in patients (Phase II)

    Measured: 1 year

  10. Frequency and severity of adverse events (Phase II)

    Measured: up to 4 years for patients with gastric cancer and up to 5 years for patients with pancreatic cancer (up to 5.5 years for the Run-in Cohort).

  11. Biomarker of GAIA-102(Phase II)

    Protein expression levels are measured in ascites and blood as biomarkers. The following are the markers to be measured; CCL3/CCL4/CCL5/CCL20/CXCL9/CXCL10/CXCL11

    Measured: pre-dose

Timeline

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

  1. First posted30 Jun 2022
  2. Study start8 Jun 2022
  3. Primary completion31 Mar 2032 (estimated)
  4. Study completion31 Mar 2032 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438459
Sponsor's protocol ID
CTR024-001
Status last verified
Sep 2026
First submitted
13 Jun 2022
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GAIA-102, Pembrolizumab and Trifluridine/tipiracil hydrochloride (FTD/TPI) in people with Gastric Cancer and Pancreatic Cancer, run by Kyushu University 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 22 inclusion and 18 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 15 Sep 2026. 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 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 Eiji Oki (+81-92-642-5479, oki.eiji.857@m.kyushu-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I) (time frame: Cycle 1 (Cycle period is 28 days)). The study lists 4 primary outcomes in all. 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 NCT05438459.

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 15 Sep 2026.

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