UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046974 |
|---|---|
| Receipt number | R000053596 |
| Scientific Title | Phase I / II Clinical Trial of GAIA-102 for advanced and relapse NSCLC |
| Date of disclosure of the study information | 2022/02/23 |
| Last modified on | 2022/02/22 15:51:36 |
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Basic information
Public title
Phase I / II Clinical Trial of GAIA-102 for advanced and relapse NSCLC
Acronym
GAIA-102-LC01
Scientific Title
Phase I / II Clinical Trial of GAIA-102 for advanced and relapse NSCLC
Scientific Title:Acronym
GAIA-102-LC01
Region
| Japan |
Condition
Condition
advanced and relapse NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
[Phase I Part]
The GAIA-102 cohort (Level A1~A3) and the GAIA-102 + Pembrolizumab cohort will be confirmed the safety and recommendation dose of Phase II Part.
[Phase II Part]
At the recommendation dose confirmed in Phase I Part, and the safety and efficacy of GAIA-102 alone or with pembrolizumab for NSCLC will be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Phase I part]
- Presence or absence of DLT expression
- Frequency and severity of adverse events
[Phase II part]
- Objective Response Rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
GAIA-102 is administered as a single agent or with Pembrolizumab.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Isamu |
| Middle name | |
| Last name | Okamoto |
Organization
Kyushu University Hospital
Division name
Pulmonology
Zip code
812-8582
Address
3-1-1,Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-641-1151
mtashiro@gaia-biomed.com
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Tashiro |
Organization
GAIA BioMedicine Inc.
Division name
Research and Development Department
Zip code
812-8582
Address
Rm 403, Collaborative Research Station II, Kyushu University Hospital Campus 3-1-1 Maidashi, Higashi
TEL
092-642-4708
Homepage URL
https://gaia-biomed.com
mtashiro@gaia-biomed.com
Sponsor or person
Institute
GAIA BioMedicine Inc.
Institute
Department
Personal name
Funding Source
Organization
GAIA BioMedicine Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kyushu University Hospital
Address
Rm 403, Collaborative Research Station II, Kyushu University Hospital Campus 3-1-1 Maidashi, Higashi-ku Fukuoka 812-8582, JAPAN
Tel
092-642-5774
mtashiro@gaia-biomed.com
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT2073210080
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053596
