Manavata Clinical Research Institute | HCG Manavata Cancer Centr
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About
This is first in human (FIH) study to a) evaluate the safety and tolerability profile of GRC54276, b) determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D), and c) pharmacokinetic profile of GRC54276 alone and in combination with pembrolizumab or atezolizumab in participants with advanced solid tumors and lymphomas.
Enrollment
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Inclusion criteria
Exclusion criteria
Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.
Subjects with uncontrolled or untreated brain metastasis or leptomeningeal disease. Subjects with equivocal findings or with confirmed brain metastases are eligible provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for at least 4 weeks prior to the first dose of study drug(s)
Any active malignancy ≤2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
Any condition that required systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first dose of study drug(s), with the following exceptions:
Pregnant/planning to be pregnant or breast-feeding women.
Any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study (based on the investigator's judgment).
Any known severe allergic reaction to pembrolizumab/atezolizumab or its excipients.
Primary purpose
Allocation
Interventional model
Masking
320 participants in 3 patient groups
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Central trial contact
Jatin Kadam
Data sourced from clinicaltrials.gov
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