NCT03009058

Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer

A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Immodulon Therapeutics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type. The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.

Detailed description

The study will consist of three phases - Screening, Treatment and Maintenance. Patients who provide informed consent, will participate in a Screening period of up to 28 days to establish eligibility. Once eligibility is confirmed, patients will enter the Treatment Phase of the study. In the Treatment Phase all patients will receive IMM-101 for 28 weeks. At Week 32, if the Investigator considers it in the patients' best interest patients will progress to the Maintenance Phase of the study and will continue to be dosed every 4 weeks (or as close to this interval as permitted due to practical or logistical considerations). Patients will be followed up for assessment of safety, response to treatment, survival, and immunological markers for up to 4.5 years.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IMM-101	A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
DRUG	Gemcitabine	Standard of Care chemotherapy
DRUG	Nab-paclitaxel	Standard of Care chemotherapy
DRUG	Capecitabine	Standard of Care chemotherapy
DRUG	Folinic Acid	Standard of Care chemotherapy
DRUG	Fluorouracil	Standard of Care chemotherapy
DRUG	Irinotecan	Standard of Care chemotherapy
DRUG	Oxaliplatin	Standard of Care chemotherapy
BIOLOGICAL	cetuximab	Standard of Care immunotherapy
BIOLOGICAL	Anti-PD1	Standard of Care immunotherapy
BIOLOGICAL	Ipilimumab	Standard of Care immunotherapy
DRUG	Cyclophosphamide	Standard of Care chemotherapy

Timeline

• Start date: 2017-05-31
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2017-01-04
• Last updated: 2024-11-25
• Results posted: 2024-11-25

Locations

4 sites across 2 countries: France, United Kingdom