SLV-154 Treatment of Metastatic Solid Tumors
A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors
1 other identifier
interventional
70
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2025
CompletedFirst Posted
Study publicly available on registry
January 13, 2025
CompletedStudy Start
First participant enrolled
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
January 23, 2026
January 1, 2026
1.6 years
January 3, 2025
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MTD and/or RDR
Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-154
Through the duration of treatment, up to approximately 18 months
Secondary Outcomes (11)
SLV-154 administration
Through the duration of treatment, up to approximately 18 months
SLV-154 Safety
Through the duration of treatment, up to approximately 18 months
Evaluation of use of concomitant medications
Through the duration of treatment, up to approximately 18 months
SLV-154 Pharmacokinetics
Varying timepoints through the duration of treatment, up to approximately 18 months
Immunogenicity
Varying timepoints through the duration of treatment, up to approximately 18 months
- +6 more secondary outcomes
Study Arms (8)
Dose Level 1
EXPERIMENTAL0.75 mg/kg
Dose Level 2
EXPERIMENTAL1.5 mg/kg
Dose Level 3
EXPERIMENTAL3.0 mg/kg
Dose Level 4
EXPERIMENTAL5.0 mg/kg
Dose Level 5
EXPERIMENTAL7.5 mg/kg
Dose Level 6
EXPERIMENTAL10.0 mg/kg
Dose Level 7
EXPERIMENTAL12.5 mg/kg
Dose Level 8
EXPERIMENTAL15.0 mg/kg
Interventions
SLV-154
Eligibility Criteria
You may qualify if:
- 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 with the primary history comprising one of the following:
- SCCHN
- NSCLC
- SCLC
- Breast cancer
- Cervical cancer
- Endometrial cancer
- Ovarian cancer
- Urothelial cancer
- Sarcoma
- Thyroid cancer
- Presence of metastatic disease that has progressed during or following previous treatment.
- Presence of radiographically measurable disease.
- +14 more criteria
You may not qualify if:
- 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.
- Significant screening ECG abnormalities.
- Pregnancy or breastfeeding.
- Major surgery within 4 weeks before the start of study therapy.
- Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.
- Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.
- Concurrent participation in another therapeutic or imaging clinical trial.
- Other conditions likely to interfere with a subject's ability to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Washington University
St Louis, Missouri, 63110, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Oncology Consultants
Houston, Texas, 77030, United States
Mays Cancer Center; University of Texas Health San Antonio
San Antonio, Texas, 78229, United States
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2025
First Posted
January 13, 2025
Study Start
May 14, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
A CSR and publication of results is planned but we currently do not intend to share individual participant data with other researchers.