Study to Evaluate the Safety of IMM-01 in Patients With Advanced Solid Tumours

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 10
• Participant gender: All

Summary

A study to assess the safety of IMM-01 in participants with advanced solid tumors

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Modulate Therapeutics Ltd
• Treatments: Losartan

Criteria

Inclusion Criteria:

• Histological or cytological evidence of cancer (advanced solid tumours, excluding primary brain tumours) that is locally advanced and/or metastatic

• Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

• Have an estimated life expectancy of greater than or equal to (≥)12 weeks

• Have adequate organ function

• Renal: Estimated glomerular filtration rate (eGFR) ≥45 milliliters per minute (mL/min/1.73m2)

• Have discontinued cytotoxic/cytostatic therapy, and cancer-related hormonal therapy at least 21 days or a minimum of 5 half-lives prior to study enrolment (6 weeks for mitomycin-C or nitrosoureas) and have discontinued radiotherapy at least 7 days prior to the first dose of study drug if radiation field did not encompass bone marrow. Or have recovered back to baseline or Grade 1 for any therapy related Adverse Events (AE) with the exception of alopecia or Grade 1 neuropathy

• Have received at least 1 but no more than four prior systemic anti-cancer therapies for metastatic or locally advanced disease, including one immune-oncology agent

• Have adequate venous access

• Males and females with reproductive potential must agree to use medically approved contraceptives during the study and for 3 months following the last dose of study treatment

• Females of child-bearing potential must have had a negative serum or urine pregnancy test result less than or equal to (≤)28 days prior to the first dose of study treatment and a negative serum or urine pregnancy test result ≤1 day prior to the first dose

• Tumour lesions that are considered evaluable by Response Evaluable Criteria in Solid Tumours (RECIST) Patients must be able to tolerate IV contrast for radiological evaluation

• Have discontinued any prior immune-oncology agent at least 6 weeks prior to enrollment

Additional Inclusion Criteria for Part A:

• Amenable to undergo mandatory biopsies (baseline and on treatment) at dose levels that required them based on safety observations as well as requirements for demonstration of mechanism of action

Additional Inclusion Criteria for Subset (approximately (~)50% per tumour type) of Part B:

• Amenable to undergo mandatory biopsies (baseline and on treatment)

• For Squamous Cell Carcinoma of the Head and Neck (SCCHN):

• Must have failed at least one platinum-containing regimen for metastatic disease or experienced recurrent disease within 6 months of completing a platinum-containing regimen

• For Squamous Cell Carcinoma (SCC) of the oesophagus:

• Must have failed at least one platinum-containing regimen for metastatic disease or experienced recurrent disease within 6 months of completing a platinum-containing regimen

• For metastatic Uveal Melanoma (UM):

• May have failed up to four local liver therapies such as trans arterial chemoembolization (TACE)

• May have failed up to two prior systemic therapies for metastatic disease

• For Renal Cell Carcinoma (RCC):

• May have failed up to four prior systemic therapies for metastatic or locally advanced disease including 1 immunotherapy agent

• For Colorectal Cancer with mismatch-repair (MMR) deficiency

• Must have failed at least one chemotherapy regimen for metastatic disease or experienced recurrent disease within 6 months

• May have failed an anti-angiogenesis agent

• May have failed an anti-epidermal growth factor receptor (EGFR) agent

• May have failed one immunotherapy agent

Exclusion Criteria:

• Symptomatic central nervous system (CNS) metastasis. Patients with treated Central Nervous System (CNS) metastases are eligible, provided their disease is stable for minimum of 4 weeks, asymptomatic, and they are not currently receiving corticosteroids

• Grade 2 or greater peripheral neuropathy

• History of organ transplant (e.g., heart, lungs, liver, and kidney)

• Females who are pregnant or nursing

• Allogeneic bone marrow transplant

• Prior Interleukin-2 (IL-2) treatment or known hypersensitivity to IL-2

• Patients with a history of active acquired immune deficiency syndrome (AIDS), who are known to be antigen positive Hepatitis B, or Hepatitis C

• New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction (MI) or stroke within the past 6 months. Symptomatic bradycardia or other symptomatic conduction abnormities. Unstable angina.

• Any medical condition which places the patient at unacceptable risk