SLV-324 Treatment of Metastatic Solid Tumors
ConditionMetastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSolve Therapeutics
About this trial
This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-324 across a range of dose levels when administered to subjects with metastatic solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women (as appropriate for cancer type) of age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records.
Presence of metastatic disease that has progressed during or following previous treatment.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
SLV-324 intravenous (IV infusion)
DrugSLV-324 will be administered as an IV infusion
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: SLV-324 intravenous (IV infusion)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MTD or RDR
Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-324
Time frame
Through the duration of treatment, up to approximately 18 monthsSecondary outcomes
1
SLV-324 Administration as Assessed by Prescribing Records
Number of infusions prescribed and administered, body-weight-adjusted and total doses administered, duration of infusions, and number of infusion delays or interruptionsSLV-324 administration as assessed by prescribing records
Time frame
Through the duration of treatment, up to approximately 18 months2
SLV-324 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 (dose-limiting toxicities), serious adverse events (SAEs), or adverse events (AEs) leading to interruption, modification, or discontinuation of study drug administration.
Time frame
Up to approximately 18 months.3
Evaluation of use of supportive care and other 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-324 Pharmacokinetics: Maximum Concentration (Cmax)
Cmax of SLV-324 antibody-drug conjugate, total antibody, and free payload
Time frame
Varying timepoints through the duration of treatment, up to approximately 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov