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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05207371
Other study ID # GAIA-102-LC01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 1, 2021
Est. completion date December 1, 2025

Study information

Verified date January 2022
Source GAIA BioMedicine Inc.
Contact Masayoshi Tashiro, master
Phone +81-92-642-4708
Email mtashiro@gaia-biomed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase I Part : Confirm the safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer, and decide recommended dose for Phase II. Phase II Part : Explore the efficacy and safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer at the recommended dose of GAIA-102 decided in the Phase I part.


Description:

Phase I Part : The GAIA-102 cohort (Level A1~A3) and the GAIA-102 + Pembrolizumab cohort (Level B1~B3) will be implemented in a 3 + 3 design. First, start from Level A1 and set the DLT evaluation period until Day 28 of Cycle 1, and confirm the safety up to Cycle 1_Day 28 of Level A1. After that, Level A2 and Level B1 will be started in parallel. After that, unless MTD is recognized, the safety at each level will be confirmed in sequence, and the recommended doses of Phase II part will be determined. Phase II Part : At the recommended number of doses confirmed in Phase I Part, 20 patients will be administered up to 3 cycles, and the safety and efficacy of GAIA-102 alone or with pembrolizumab will be evaluated by ORR.


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date December 1, 2025
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Patients who have been confirmed to have NSCLC by histological or cytological examination 2. Patients with ECOG performance status (PS) 0-1 at the time of obtaining consent 3. Patients aged 20 years or older at the time of obtaining consent Exclusion Criteria: 1. Patients with symptomatological cranial nerve system metastasis. If treatment for cranial nerve system metastasis has already been performed and the neurologically recovered state has been maintained for 2 weeks or more before registration, registration is possible. 2. Patients diagnosed with cancerous meningitis 3. Patients who received allogeneic hematopoietic stem cell transplantation 4. Patients with active autoimmune disease

Study Design


Intervention

Biological:
Biological
Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®?)

Locations

Country Name City State
Japan Kyushu University Hospital Fukuoka-shi Fukuoka
Japan Kitakyushu Municipal Medical Center Kitakyushu Fukuoka
Japan Kurume University Hospital Kurume Fukuoka

Sponsors (1)

Lead Sponsor Collaborator
GAIA BioMedicine Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I part Dose Limiting Toxicity Cycle 1 (Cycle period is 28 days)
Primary Phase II part Objective Response Rate (%) Week 26
Secondary Phase I part Objective Response Rate
Disease Control Rate
Week 26
Secondary Phase I part Progression-free Survival
Overall Survival
2 year
Secondary Phase II part Progression-free Survival
Overall Survival
2 year
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