Expanded Access Program Using IMM-101 for Patients With NCT04137822

Clinical Trial Details — Status: No longer available

Administrative data
NCT number	NCT04137822
Other study ID #	2019-IMM101IMM-EU
Secondary ID
Status	No longer available
Phase
First received
Last updated

Study information
Verified date	August 2020
Source	Impatients N.V. trading as myTomorrows
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Expanded Access

Clinical Trial Summary

An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.

Description:

IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense. Since it is a heat-killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms.

Five studies with IMM-101 have been completed including a 110-patient randomised Phase II study in pancreatic cancer and exploratory studies in other solid tumours (melanoma, colorectal cancer and advanced melanoma).

Recruitment information / eligibility
Status	No longer available
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: This Expanded Access Program is available for patients of 18 years or older with advanced pancreatic cancer for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable. Exclusion Criteria: Female patient of child-bearing potential who is not, in the opinion of the physician, using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]).

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• IMM-101
IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline. The treatment regimen with IMM-101 is one dose given every 2 weeks for three doses followed by 4 weeks rest, then one dose is given every 2 weeks for a further three doses. Subsequent doses are given every 4 weeks.

Locations
Country	Name	City	State
France	France	Paris
United Kingdom	UK	London

Sponsors *(2)*
Lead Sponsor	Collaborator
Impatients N.V. trading as myTomorrows	Immodulon Therapeutics Ltd

Countries where clinical trial is conducted

France, United Kingdom,

References & Publications (2)

Costa Neves M, Giakoustidis A, Stamp G, Gaya A, Mudan S. Extended Survival after Complete Pathological Response in Metastatic Pancreatic Ductal Adenocarcinoma Following Induction Chemotherapy, Chemoradiotherapy, and a Novel Immunotherapy Agent, IMM-101. Cureus. 2015 Dec 26;7(12):e435. doi: 10.7759/cureus.435. — View Citation

Dalgleish AG, Stebbing J, Adamson DJ, Arif SS, Bidoli P, Chang D, Cheeseman S, Diaz-Beveridge R, Fernandez-Martos C, Glynne-Jones R, Granetto C, Massuti B, McAdam K, McDermott R, Martín AJ, Papamichael D, Pazo-Cid R, Vieitez JM, Zaniboni A, Carroll KJ, Wa — View Citation

See also
Status	Clinical Trial	Phase
Completed	`NCT05305001` - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed	`NCT02526017` - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers	Phase 1
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Recruiting	`NCT04927780` - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer	Phase 3
Recruiting	`NCT06054984` - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT05919537` - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation	Phase 1
Terminated	`NCT03140670` - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy	Phase 2
Terminated	`NCT00529113` - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer	Phase 1
Recruiting	`NCT05168527` - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients	Phase 2
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05391126` - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care	N/A
Terminated	`NCT03300921` - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer	Phase 1
Completed	`NCT03153410` - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas	Early Phase 1
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Recruiting	`NCT05679583` - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer	Phase 2
Recruiting	`NCT04183478` - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer	Phase 2/Phase 3
Terminated	`NCT03600623` - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT04584008` - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics	N/A
Recruiting	`NCT05351983` - Patient-derived Organoids Drug Screen in Pancreatic Cancer	N/A
Completed	`NCT04290364` - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study

Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer

Clinical Trial Details — Status: No longer available

Administrative data

Study information