Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

NCT05943041 | Completed Phase 1

• 1 other identifier: GB-X01-101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor; Colorectal Cancer; Sigmoid Colon Cancer; Rectosigmoid Junction Cancer; Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

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

  4 weeks

• Incidence of Adverse Events from baseline to 8 weeks

  assessed up to 8 weeks

Other Outcomes (5)

• Quantity and persistence of GB104 in fecal sample from baseline to 8 weeks

  assessed up to 8 weeks

• Changes in composition of gut microbiota in fecal samples from baseline to 8 weeks

  assessed up to 8 weeks

• Changes in immune status from baseline to 8 weeks

  assessed up to 8 weeks

Study Arms (3)

GB104: Dose level 1

EXPERIMENTAL

Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.

Drug: GB104(Level 1)

GB104: Dose level 2

EXPERIMENTAL

Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.

Drug: GB104(Level 2)

GB104: Dose level 3

EXPERIMENTAL

Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.

Drug: GB104(Level 3)

Interventions

GB104(Level 1) DRUG

One capsule QD oral administration for 28 days

GB104: Dose level 1

GB104(Level 2) DRUG

Three capsules QD oral administration for 28 days

GB104: Dose level 2

GB104(Level 3) DRUG

Five capsules QD oral administration for 28 days

GB104: Dose level 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy and have completed 3 months since the last treatments
• Subjects who have not received any adjuvant therapy and have completed 3 months from the radical colectomy
• Subjects who have undergone stoma closure and have completed 3 months after stoma closure
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GILongevity: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 81 Ilwon-ro, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Sigmoid Neoplasms; Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Colonic Neoplasms; Sigmoid Diseases

Study Officials

• Woo Yong Lee, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Group Assignment (3+3 model)

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 12, 2023
• Study Start: April 28, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)