Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Last updated: January 13, 2022
Sponsor: GAIA BioMedicine Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT05207371
GAIA-102-LC01
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have been confirmed to have NSCLC by histological or cytologicalexamination
  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

Exclusion Criteria:

  1. Patients with symptomatological cranial nerve system metastasis. If treatment forcranial nerve system metastasis has already been performed and the neurologicallyrecovered 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

Total Participants: 38
Study Start date:
December 01, 2021
Estimated Completion Date:
December 01, 2025

Study Description

Phase I Part :

The GAIA-102 cohort (Level A1A3) and the GAIA-102 + Pembrolizumab cohort (Level B1B3) 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.

Connect with a study center

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Kitakyushu Municipal Medical Center

    Kitakyushu, Fukuoka 802-8561
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka 830-0011
    Japan

    Active - Recruiting

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