This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.
Men or women (as appropriate for cancer type) of age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
SCCHN
NSCLC
Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.
Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.
Significant cardiovascular event or comorbidity.
Sequential
SLV-154
DrugSLV-154
8
Treatment groupsSee each treatment group below.
MTD and/or RDR
Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-154
SLV-154 administration
SLV-154 drug administration as assessed by prescribing records
SLV-154 Safety
Collection of type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events (TEAEs); laboratory abnormalities; vital sign/oxygen saturation abnormalities; adverse electrocardiogram (ECG) findings; DLTs; serious adverse events (SAEs); adverse events of special interest (AESIs); or adverse events (AEs) leading to interruption, modification, or discontinuation of study drug administration.
Evaluation of use of concomitant medications
Type, frequency, and timing of use of supportive care and other concomitant medications
SLV-154 Pharmacokinetics
Evaluation of the pharmacokinetic profile of SLV-154
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