This study is being done to test the safety of elraglusib when taken once a day and to assess:
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for inclusion in the study:
Able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures
Age ≥ 18 years
Has histologically or cytologically confirmed diagnosis of advanced metastatic or progressive solid tumor characterized by one or more of the following:
Has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI)
Has laboratory function within specified parameters (may be repeated):
Eastern Co-operative Oncology Group (ECOG) Performance Status (PS) ≤ 2
Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first dose of study drug. Women may be neither breastfeeding nor intending to become pregnant during study participation and must agree to use effective contraceptive methods (hormonal or barrier method of birth control, or true abstinence) for the duration of study participation and in the following 6 months after discontinuation of study treatment
Male participants with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 6 months after discontinuation of study treatment and use appropriate barrier contraception or true abstinence
Must not be receiving any other investigational medicinal product
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from the study:
Pregnant or lactating
Known to be hypersensitive to any of the components of elraglusib tablets or to the excipients used in its formulation
Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and/or infertility. Recovery is defined as ≤ Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE), v6.0
The following risk factors for abnormal heart rhythms/QT prolongation:
Has significant cardiovascular impairment: congestive heart failure greater than New York Heart Association (NYHA) Class II, family history of long QT syndrome, unstable angina, or stroke within 6 months of the first dose of study therapy
Has had a myocardial infarction within 6 months of the first dose of study therapy or has ECG abnormalities that are deemed medically relevant by the investigator
Has symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Participants with stable brain metastases or leptomeningeal disease are eligible provided they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
Has had major surgery within 14 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened [pleural cavity, peritoneum, meninges], the surgery is considered major)
Has any medical and/or social condition which, in the opinion of the Investigator or Medical Monitor would preclude study participation
Previous anticancer therapies with any of the following:
Use of sensitive substrates of CYP3A4 with a narrow therapeutic from 14 days prior to first administration of study drug, during the study, and until Safety Follow-up Visit.
Use of strong inhibitors or inducers of CYP2C19, CYP1A2 and CYP3A4 from 14 days prior to first administration of study drug, during the study, and until Safety Follow-up Visit.
Use of inhibitors or inducers of major drug transporters (i.e., OATP1B1, OATP1B3, OCT1, OCT2 and MATE1/2K) from 14 days prior to first administration of study drug, during the study, and until the Safety Follow-up Visit.
Concomitant participation in another clinical study with study drug(s) or device
Unable to swallow a tablet or has any condition(s) that, in the opinion of the treating investigator, may affect gastrointestinal absorption
Considered to be a member of a vulnerable population (for example, prisoners)
Elraglusib 250 mg tablets will be administered once daily with food in 21-day cycles. DG-1: 125mg (Days 1, 3, 5 of a 21 day cycle) DG1: (Starting Dose) 125 mg/QD for 21 days DG2: 250mg/QD for 21 days DG3: 500mg QD for 21 days DG4: 750mg/QD for 21 days, Dosing will continue until MTD or MED is identified. Any higher dose levels which are explored will not exceed 50% increment relative to the prior cohort rounded down to the nearest 250 mg dose (or 125 mg dose if necessary).
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