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)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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. Phase II Part : 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.

• 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 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

• 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)

⁃ eGFR \>=30mL/min/1.73m2

⁃ Expected to survive for 3 months or more at the enrollment

⁃ Written informed consent

Locations
Other Locations
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Contact Information
Primary
Eiji Oki
oki.eiji.857@m.kyushu-u.ac.jp
+81-92-642-5479
Time Frame
Start Date: 2022-06-08
Estimated Completion Date: 2027-06-08
Participants
Target number of participants: 96
Treatments
Experimental: GAIA-102 as a monotherapy
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.
Experimental: GAIA-102 and pembrolizumab in combination
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.
Sponsors
Collaborators: GAIA BioMedicine Inc., Toho University - Omori Medical Center, Teikyo University Hospital, Kyushu Cancer Center, Kindai University Hospital, Kansai Medical University Hospital, Jichi Medical University
Leads: Kyushu University

This content was sourced from clinicaltrials.gov