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About
This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.
Enrollment
Sex
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Inclusion criteria
Part A Escalation Cohorts:
o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies
Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:
Tumors with all histological diagnosis or tissue origin may be enrolled
Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
353 participants in 24 patient groups
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Data sourced from clinicaltrials.gov
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