HEM1036 Phase 2 Study in Low Anterior Resection Syndrome

Launched by HEM PHARMA INC. · Aug 30, 2022

Keywords

ClinConnect Summary

The HEM1036 Phase 2 Study is a clinical trial aimed at testing a new treatment for Low Anterior Resection Syndrome (LARS), a condition that can occur after surgery for rectal cancer. This study will compare HEM1036 to a placebo (a substance with no active treatment) to see how effective and safe it is for people with LARS. The trial is not yet recruiting participants, but it is looking for men and women between the ages of 18 and 75 who have had surgery for rectal cancer and are experiencing significant symptoms of LARS.

To be eligible for this study, participants must have completed their cancer treatment at least six months before joining the trial and have a LARS score above 20, indicating they are experiencing considerable difficulties. Participants will need to visit the study site for check-ups and will be monitored throughout the study. Importantly, those with certain medical histories, such as previous major surgeries or current treatments that could interfere with the study, may not be eligible. This trial represents an opportunity to potentially benefit from a new treatment while contributing to research that could help others with similar conditions in the future.

Gender

ALL

Eligibility 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