CompletedPhase 1

Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

South Korea9 participantsStarted 2023-04-28

Plain-language summary

Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects who sign on an informed consent form willingly
✓. Subjects who have histological and radiological diagnosis of colorectal cancer
✓. Males and females aged between 19 and 80 years at the time of screening
✓. Subjects who have undergone radical colectomy and received the following treatments before participating in the clinical trial, and have completed the specified period:
✓. Subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of GB104
✓. Subjects who have received adjuvant chemotherapy or radiation therapy, and have completed 3 months after completing the treatment, and toxicity from previous adjuvant treatment must have recovered to NCI-CTCAE v5.0 grade 1
✓. Subjects who have been confirmed to have adequate hematological, renal, and hepatic function at the screening point (laboratory tests may be retested during the screening period)
✓. Female subjects of childbearing potential and sexually active men who agree to abstain from sexual activity or use an adequate method of contraception

✕. Significant cardiac dysfunction, New York Heart Association classification for chronic heart failure III-IV, symptomatic coronary artery disease, significant deep vein thrombosis; myocardial infarction within 6 months
✕. Severe active infections that require systemic antibiotics, antifungal agents, antiviral agents, or other medications that cannot be controlled
✕. Previous history of immunosuppressant within the 1 month of initial administration
✕. Known HIV infection, or active infection with hepatitis B or C
✕. Subjects who have completed a course of antibiotics within the one month prior to screening

Incidence of DLT(Dose-Limiting Toxicity) at week 4

Timeframe: 4 weeks

Incidence of Adverse Events from baseline to 8 weeks

Timeframe: assessed up to 8 weeks

NCT IDNCT05943041

SponsorGILongevity

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-22

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects who sign on an informed consent form willingly
✓. Subjects who have histological and radiological diagnosis of colorectal cancer
✓. Males and females aged between 19 and 80 years at the time of screening
✓. Subjects who have undergone radical colectomy and received the following treatments before participating in the clinical trial, and have completed the specified period:
✓. Subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of GB104
✓. Subjects who have received adjuvant chemotherapy or radiation therapy, and have completed 3 months after completing the treatment, and toxicity from previous adjuvant treatment must have recovered to NCI-CTCAE v5.0 grade 1
✓. Subjects who have been confirmed to have adequate hematological, renal, and hepatic function at the screening point (laboratory tests may be retested during the screening period)
✓. Female subjects of childbearing potential and sexually active men who agree to abstain from sexual activity or use an adequate method of contraception

✕. Significant cardiac dysfunction, New York Heart Association classification for chronic heart failure III-IV, symptomatic coronary artery disease, significant deep vein thrombosis; myocardial infarction within 6 months
✕. Severe active infections that require systemic antibiotics, antifungal agents, antiviral agents, or other medications that cannot be controlled
✕. Previous history of immunosuppressant within the 1 month of initial administration
✕. Known HIV infection, or active infection with hepatitis B or C
✕. Subjects who have completed a course of antibiotics within the one month prior to screening