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

K

Kyushu University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Gastric Cancer
Pancreatic Cancer

Treatments

Biological: Phase II part
Biological: Phase I part

Study type

Interventional

Funder types

Other

Identifiers

NCT05438459
CTR024-001

Details and patient eligibility

About

Phase I Part : Confirm the safety of GAIA-102 GAIA-102 as a single agent 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. Phase II Part : Research the efficacy and safety of as a single agent 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.

Enrollment

96 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Unresectable, advanced and relapsed gastric cancer with malignant ascites or unresectable, advanced and relapsed pancreatic cancer with malignant ascites
  • Refractory/intolerant to more than 3 regimens of therapy for gastric cancer (more than 2 regimens acceptable for Phase II) or more than 2 regimens of therapy for pancreatic cancer (more than 1 regimen acceptable for Phase II)
  • Abdominal port placement is possible
  • No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
  • Diagnosed gastric adenocarcinoma or pancreatic cancerwith by histological or cytological examination
  • Negative (MSS= not MSI-high) by microsatellite instability test
  • Eastern Cooperative Oncology Group (ECOG) Performance status(PS) 0-2
  • 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)
  • Serum creatinine <=1.5mg/dL
  • CCr >=30mL/min
  • Expected to survive for 3 months or more at the enrollment
  • Written informed consent

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

GAIA-102 as a single agent
Experimental group
Description:
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.
Treatment:
Biological: Phase I part
Biological: Phase II part
GAIA-102 and pembrolizumab in combination
Experimental group
Description:
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. Pembrolizumab:200 mg on Day 1.
Treatment:
Biological: Phase I part
Biological: Phase II part

Trial contacts and locations

1

Loading...

Central trial contact

Eiji Oki

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems