Health TrialsbyHealthPanel

SLR-108 PET Imaging in Subjects With 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 study evaluating the feasibility of using SLR-108 for positron-emission tomography (PET) imaging of metastatic solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Based on the most recent tumor assessment, 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 study drug administration.

Significant cardiovascular event or comorbidity.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SLR-108

    Drug

    SLR-108 is an antibody-radionuclide conjugate.

  • SLX-1411

    Drug

    SLX-1411 is a non-radiolabeled antibody.

Treatment groups

70 Participants
are divided into 5 treatment groups
Group A: Part 1: Cohort 1Experimental treatment 2 interventions
Group B: Part 1: Cohort 2Experimental treatment 2 interventions
Group C: Part 1: Cohort 3Experimental treatment 2 interventions
Group D: Part 2Experimental treatment 2 interventions
Group E: Part 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Optimal antibody protein dose

The appropriate antibody dose (in mg) for optimal imaging

Time frame
Through Day 14
2

Optimal administered activity

The appropriate radioactivity dose (in mCi) for optimal imaging

Time frame
Through Day 14
3

Optimal SLR-108 PET timing

The optimal timing of PET imaging for differentiating tumor tissue from normal background tissue

Time frame
Through Day 14

Secondary outcomes

1

Study drug administration

Duration of study drug administration (in minutes) as assessed by radiopharmacy and clinical records

Time frame
Through Day 0
2

Study drug safety

Type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events (TEAEs); laboratory abnormalities; dose-limiting toxicities (DLTs); serious adverse events (SAEs); adverse events of special interest (AESIs); or AEs leading to interruption or modification of study drug administration.

Time frame
Through Day 14
3

Supportive care profile

Number of subjects receiving supportive care and other concomitant medications

Time frame
Through Day 14
4

Study drug pharmacokinetics - Cmax

Study drug maximum plasma concentration (Cmax)

Time frame
Through Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Solve Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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