Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Commercial reasons
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD1 | Biological | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Folinic Acid | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| IMM-101 | Biological | — | UNRESOLVED |
| Ipilimumab | Biological |
Design
Arms and outcomes
Arms (17)
- type
- EXPERIMENTAL
- label
- IMM-101 + Gem panc ca
- description
- IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
- interventionNames
- Biological: IMM-101
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- IMM-101+Gem/nab-paclitaxel panc ca
- description
- IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
- interventionNames
- Biological: IMM-101
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic or unresectable cancer and considered by their physician to be indicated for a new line of SOC as listed in the protocol * Are ineligible for a disease specific clinical study with IMM-101 * Have an estimated life expectancy greater than 3 months (from Day 0) * Give signed informed consent for participation in the study * Have an Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) Performance Status of ≤2 at Day 0. * Have adequate bone marrow, hepatic and renal function Exclusion Criteria: * Patient has previously received treatment with IMM-101 * Patient is currently part way through a course of chemotherapy or immunotherapy * Patient is receiving concomitant treatment with another investigational product * Patient has received an investigational drug within the 4 weeks prior to IMM 101 administration * Patient has significant cardiovascular disease * Patient has any previous or concurrent malignancy (excluding adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non melanoma skin cancer, or if previous malignancy was more than 5 years prior to Screening and there are no signs of recurrence) * Patient has co existing active infection or medical condition which will substantially increase the risk associated with the patient's participation in the study * Patient has uncontrolled hypercalcaemia * Patient has previously experienced an allergic reaction to any mycobacterial product. * The patient has a history of non-infectious pneumonitis that required steroids or current pneumonitis * Patient has received live vaccine within 30 days of planned start of study medication * Patient is pregnant or a breast feeding woman. * Patient is unwilling to use a medically acceptable, effective method of contraception throughout the treatment period and for at least 6 months after discontinuation of treatment. * Patient has used depot corticosteroids in the 6 weeks before initiation of Screening * Patient has had chronic use of systemic corticosteroids within the 2 week period before the first administration of IMM-101 * Patient has received a blood transfusion within 4 weeks prior to Screening * In the opinion of the Investigator, the patient is unable or unwilling to comply with the protocol.
References
Publications (0)
Data not yet available