Study of IGM-8444 as a Single Agent and in Combination With Chemotherapy-based Regimens in Subjects With Solid Cancers

  • STATUS
    Recruiting
  • End date
    Oct 29, 2023
  • participants needed
    230
  • sponsor
    IGM Biosciences, Inc.
Updated on 25 August 2021
platelet count
cancer
measurable disease
growth factor
serum bilirubin level
bevacizumab
cancer chemotherapy
targeted therapy

Summary

This study is a first-in-human, Phase 1, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics of IGM-8444 as a single agent and in combination with a chemotherapy-based regimen in patients with relapsed and/or refractory solid tumors.

Description

Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-8444 in patients with solid tumors and IGM-8444 in combination with FOLFIRI for colorectal carcinoma patients. The IGM-8444 single agent expansion cohort will enroll the following tumor types: colorectal carcinoma, gastric, non-small cell lung cancer, sarcoma, and an all-comers cohort which will include relapsed/refractory non-hodgkins lymphoma patients. The IGM-8444 + FOLFIRI with or without bevacizumab combination expansion cohorts will enroll colorectal carcinoma patients. IGM-8444 will be administered intravenously (IV). An alternative dosing schedule may be evaluated.

Details
Condition Non-Small Cell Lung Cancer, Colorectal Cancer, Connective and Soft Tissue Neoplasm, Rectal disorder, Lymphoma, Lymphoma, Sarcoma, Gastropathy, Gastric Cancer, Stomach Discomfort, Non-Hodgkin's Lymphoma, All Solid Tumors, Colon Cancer Screening, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Solid Tumor, Solid Neoplasm, Gastric Carcinoma, Solid Tumour, Sarcoma (Pediatric), Stomach Cancer, Soft Tissue Sarcoma, colorectal neoplasm, non-hodgkin's lymphoma (nhl), gastric cancers, sarcomas, soft tissue sarcomas, colorectal cancers, nsclc, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment bevacizumab, FOLFIRI, IGM-8444
Clinical Study IdentifierNCT04553692
SponsorIGM Biosciences, Inc.
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years at time of signing Informed Consent Form
Life expectancy of at least 12 weeks
ECOG Performance Status of 0 or 1
Patients who are either refractory to or intolerant of existing standard therapy or for whom no effective further standard of care therapy exists
No more than three prior therapeutic regimens ("therapeutic" is defined as any cytotoxic, biologic, or targeted therapy [approved or investigational] with intent to treat the cancer) administered for the treatment of cancer in the advanced/metastatic setting
For dose escalation cohorts only: Patients with either measurable or evaluable disease
Patients with histologic documentation of incurable, locally advanced or metastatic prostate cancer with non-measurable disease are eligible if they have an increase in prostate-specific antigen (PSA) level of > 50% from current level, the absolute increase is 5 ng/mL, and the increase is confirmed a second time
Patients with histologic documentation of incurable, locally advanced or metastatic ovarian cancer with non-measurable disease are eligible if they have an increase of > 2 the baseline level in CA-125 (or > 2 the ULN in case of prior normal CA-125 level) and the increase is confirmed a second time
Adequate organ function as evidenced by (hematologic parameters must be assessed at least 14 days from the last growth factor support or prior transfusion, if any)
ANC 1000/L
Total hemoglobin 9 g/dL
Platelet count 100,000/L
Serum creatinine 1.5 upper limit of normal (ULN), or estimated creatinine clearance 50 mL/min (Cockcroft Gault or other institutional methods)
Serum aspartate transaminase (AST) and serum ALT 2 ULN
AST and ALT 3 ULN is allowed if liver function abnormalities are due to underlying malignancy
Total serum bilirubin 1.5 ULN regardless of liver involvement secondary to tumor
Inclusion of patients with increased serum indirect bilirubin ( 3 ULN) due to Gilbert's syndrome is permitted
Alkaline phosphatase 2.5 the ULN
Albumin 3.0 g/dL
No clinically significant pleural or peritoneal effusion requiring drainage

Exclusion Criteria

Prior DR5 agonist therapy
Prior Bcl-family inhibitor therapy
Concomitant use of agents well-known to cause liver toxicity
Known clinically significant history of liver disease including Child-Pugh Class B or C, including active viral or other hepatitis (e.g., hepatitis B or hepatitis C virus), current alcohol abuse, non-alcoholic steatohepatitis (NASH), or cirrhosis
Diagnosis of any secondary malignancy within 3 years prior to enrollment
Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Current Grade > 1 toxicity (except alopecia and anorexia) from prior therapy. Patients with current Grade 2 chronic toxicities that are well-controlled by medications may be enrolled after discussion with medical monitor
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