SLV-154 Treatment of Advanced Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorSolve Therapeutics
About this trial
This is a Phase 1 study comprising a Phase 1a dose-escalation portion and a Phase 1b expansion portion evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women (as appropriate for cancer type) of age ≥12 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed diagnosis of advanced cancer as documented in medical records.
Presence of metastatic or recurrent locally advanced cancer.
Disqualifiers
Unstable malignancy involving the central nervous system.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
SLV-154
DrugSLV-154
Treatment groups
250 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Dose Level 1Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level 3Experimental treatment 1 intervention
Group D: Dose Level 4Experimental treatment 1 intervention
Group E: Dose Level 5Experimental treatment 1 intervention
Group F: Dose Level 6Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1a: MTD and/or RDR
Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-154.
Time frame
Through the duration of treatment, up to approximately 18 months2
Phase 1b: Objective response rate (ORR)
ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
Time frame
Through the duration of treatment, up to approximately 18 monthsSecondary outcomes
1
SLV-154 administration
SLV-154 drug administration as assessed by prescribing records
Time frame
Through the duration of treatment, up to approximately 18 months2
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.
Time frame
Through the duration of treatment, up to approximately 18 months3
Evaluation of use of concomitant medications
Type, frequency, and timing of use of supportive care and other concomitant medications
Time frame
Through the duration of treatment, up to approximately 18 months4
SLV-154 Pharmacokinetics
Evaluation of the pharmacokinetic profile of SLV-154
Time frame
Varying timepoints through the duration of treatment, up to approximately 18 monthsSponsors and contacts
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Source ClinicalTrials.gov