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

Immodulon Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Metastatic Cancer

Treatments: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Folinic Acid; Drug: Fluorouracil; Drug: Capecitabine; Biological: cetuximab; Drug: Gemcitabine; Biological: Anti-PD1; Drug: Nab-paclitaxel; Biological: Ipilimumab; Biological: IMM-101; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03009058

CANC 32085 (Other Identifier)

IMM-101-011

2016 001459 28 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 17 patient groups

IMM-101 + Gem panc ca

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

IMM-101+Gem/nab-paclitaxel panc ca

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

Drug: Nab-paclitaxel

IMM-101+Gem+capecitabine panc ca

Experimental group

Description:

IMM-101 will be given in combination with gemcitabine + capecitabine 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.

Treatment:

Drug: Gemcitabine

Drug: Capecitabine

Biological: IMM-101

IMM-101 + FOLFIRINOX panc ca

Experimental group

Description:

IMM-101 will be given in combination with standard FOLFIRINOX (FOLinic acid, Fluorouracil, IRINotecan and OXaliplatin) treatment. 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.

Treatment:

Drug: Fluorouracil

Drug: Folinic Acid

Drug: Oxaliplatin

Biological: IMM-101

Drug: Irinotecan

IMM-101+FOLFOX colorectal cancer (CRC)

Experimental group

Description:

IMM-101 will be given in combination with standard FOLFOX (FOLinic acid, Fluorouracil and OXaliplatin) treatment. 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.

Treatment:

Drug: Fluorouracil

Drug: Folinic Acid

Drug: Oxaliplatin

Biological: IMM-101

IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC)

Experimental group

Description:

IMM-101 will be given in combination with standard FOLFIRI (FOLinic acid, Fluorouracil and IRInotecan) + cetuximab combination treatment. 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.

Treatment:

Biological: cetuximab

Drug: Fluorouracil

Drug: Folinic Acid

Biological: IMM-101

Drug: Irinotecan

IMM-101+Gem cholangio

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

IMM-101+Gem lung ca

Experimental group

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

Treatment:

Drug: Gemcitabine

Biological: IMM-101

IMM-101+Gem + nab-paclitaxel lung ca

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

Drug: Nab-paclitaxel

IMM-101+ anti-programmed death-1 (PD1) lung ca

Experimental group

Description:

IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen.

Treatment:

Biological: IMM-101

Biological: Anti-PD1

IMM-101+Gem melanoma

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

IMM-101+ anti-programmed death-1 (PD1) melanoma

Experimental group

Description:

IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. The first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.

Treatment:

Biological: IMM-101

Biological: Anti-PD1

IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma

Experimental group

Description:

IMM-101 will be given in combination with standard treatment with ipilimumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the ipilimumab cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter.

Treatment:

Biological: IMM-101

Biological: Ipilimumab

IMM-101+Gem breast cancer

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

IMM-101+Gem/ nab-paclitaxel breast

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

Drug: Nab-paclitaxel

IMM-101 + Gem sarcoma

Experimental group

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.

Treatment:

Drug: Gemcitabine

Biological: IMM-101

IMM-101+cyclophosphamide

Experimental group

Description:

IMM-101 will be given in combination with low dose cyclophosphamide (300mg/m2 in patients with solid malignancies. 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.

Treatment:

Drug: Cyclophosphamide

Biological: IMM-101