HEM1036 Phase 2 Study in Low Anterior Resection Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-01-04
• Target enrollment: 0
• Participant gender: All

Summary

Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HEM Pharma Inc.
• Collaborator: Premier Research Group plc

Criteria

Inclusion Criteria:

1. Male and female subjects ≥18 and ≤75 years old.

2. Diagnosed with rectal cancer and undergone sphincter preserving rectal resection surgery.

3. Completed curative treatment (rectal resection, systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, radiotherapy, and stomy repairment) ≥6 months prior to Screening.

4. Current LARS with a LARS score >20 at Screening.

5. An Eastern Cooperative Oncology Group score 0 or 1 at Screening.

6. No evidence of anastomotic leakage or severe stenosis.

7. Capable of returning to study site for all study visits according to requirement of protocol and willing to comply with the policy, procedure, and restriction of the study.

8. Capable of actively communicating with the investigator/study personnel and completing the study related documents.

9. Body mass index is at least 18 kg/m2 but no more than 35 kg/m2.

Exclusion Criteria:

1. History of: Abdominoperineal resection surgery, Hartmann operation, colostomy, Transanal irrigation therapy for LARS within 2 weeks prior to Screening, Secondary operation with stoma, etc.

2. Not completed stomy repairment done at rectal resection surgery.

3. History of allergic or adverse responses to IP or Milk, yeast, soy.

4. On systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiotherapy at the time of Screening.

5. Any antibiotic use within 4 weeks before the first dose of the IP.

6. Is currently participating or has participated in another study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of the IP.

7. Tested positive for HIV antigen, Hepatitis B, C at screening

8. Past or current alcohol or drug abuse history