Advanced CancerPhase 1NCT06771219
SLV-154 Treatment of Advanced Cancers
A Phase 1 study testing SLV-154 in people with Advanced Cancer and Advanced Solid Tumor, run by Solve Therapeutics at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Cancer, Advanced Solid Tumor, Metastatic Cancer
- What is being tested?
- SLV-154
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 12 sitesUnited States
- Study dates
- 14 May 2025to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Presence of radiographically measurable disease.
- Prior receipt of one or more commercially available therapies that are indicated within product labelling or recommended under current guidelines as appropriate treatment for the subject's cancer (unless evolving data support application of SLV-154 in previously untreated subjects with high unmet medical need and inadequate and/or poorly tolerated treatment options).
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- Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.
- Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and/or fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.
- Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.
- Adequate hematological profile.
- Adequate coagulation profile.
- Adequate hepatic profile.
- Adequate renal function.
- Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.
- For female subjects of childbearing potential, a negative serum pregnancy test.
- For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.
- For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.
- Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy/aspirations and/or radiographic studies), and study restrictions.
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
Who cannot join
- 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.
- Significant screening ECG abnormalities.
- Pregnancy or breastfeeding.
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- Major surgery within 3 weeks before the start of study therapy.
- Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.
- Concurrent participation in another therapeutic or imaging clinical trial.
- Other conditions likely to interfere with a subject's ability to participate in the study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Afshin Dowlati, MD, 212-844-6031, afshin.dowlati@UHhospitals.org
- Recruiting
The James Outpatient Care West Center
Columbus, Ohio, 43210
Adam Roan, 614-685-0587, Adam.Roan@osumc.edu
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
Percy Yeung, 732-387-3378, percy.yeung@asterahealthcare.org
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Rabia Khan, 713-563-4667, RKhan@mdanderson.org
- Recruiting
Oncology Consultants
Houston, Texas, 77030
Julio Peguero, MD, 713-600-0900, jPeguero@oncologyconsultants.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Roisin O'Cearbhaill, MD, 646-888-4227, ocearbhr@mskcc.org
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Cindy Do, BSN, RN, 949-764-4624, cindy.do@hoag.org
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Dajah White-Dumpson, 215-214-1600, Dajah.White-Dumpson@fccc.edu
Shannon Fabrie, 215-728-3620, shannon.fabrie@fccc.edu
- Recruiting
Mays Cancer Center; University of Texas Health San Antonio
San Antonio, Texas, 78229
Daruka Mahadevan, MD, 210-450-1000, mahadevand@uthscsa.edu
Daruka Mahadevan
- Recruiting
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Phase 1 Clinical Trials, 206-606-7551, phase1clinicaltrial@fredhutch.org
- Recruiting
Washington University
St Louis, Missouri, 63110
Sara Mitchum, 314-273-8602, saram@wustl.edu
- Recruiting
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
CarrieAnn Brown, 253-428-8700, cbrown@nwmsonline.com
Kiersten Peart, 253-428-8700, kpeart@nwmsonline.com
About this study
Official title: A Phase 1 Dose-Escalation/Expansion Study of SLV-154 in Subjects With Advanced Cancers
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.
Read the detailed description
A Bayesian optimal interval (BOIN) design with a target dose-limiting toxicity (DLT) rate for the maximum tolerated dose (MTD) of 27% and an estimated maximum sample size of ~70 subjects will be used to guide the dose escalation and determine the recommended dosing regimen (RDR) of SLV-154. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2-stage optimal design.
SLV-154 will be administered intravenously (IV) in repeated 3-week cycles. Treatment will continue until progressive disease or discontinuation.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Metastatic Cancer
- Being tested
- SLV-154
- Keywords
- metastatic solid tumors, metastatic cancer, solid tumor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV-154Drug
SLV-154
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 0.75 mg/kg Receives: Drug: SLV-154 |
| Dose Level 2 | Experimental | 1.5 mg/kg Receives: Drug: SLV-154 |
| Dose Level 3 | Experimental | 3.0 mg/kg Receives: Drug: SLV-154 |
| Dose Level 4 | Experimental | 4.0 mg/kg Receives: Drug: SLV-154 |
| Dose Level 5 | Experimental | 5.0 mg/kg Receives: Drug: SLV-154 |
| Dose Level 6 | Experimental | 6.5 mg/kg Receives: Drug: SLV-154 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: MTD and/or RDR
Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-154.
Measured: Through the duration of treatment, up to approximately 18 months
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).
Measured: Through the duration of treatment, up to approximately 18 months
Secondary outcomes (15)
SLV-154 administration
SLV-154 drug administration as assessed by prescribing records
Measured: Through the duration of treatment, up to approximately 18 months
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.
Measured: Through the duration of treatment, up to approximately 18 months
Evaluation of use of concomitant medications
Type, frequency, and timing of use of supportive care and other concomitant medications
Measured: Through the duration of treatment, up to approximately 18 months
SLV-154 Pharmacokinetics
Evaluation of the pharmacokinetic profile of SLV-154
Measured: Varying timepoints through the duration of treatment, up to approximately 18 months
Immunogenicity
Measurement of changes in titers of circulating SLV 154-reactive antibodies (as assessed using immunoassay methods)
Measured: Varying timepoints through the duration of treatment, up to approximately 18 months
Time to Response (TTR)
TTR: interval from the start of study drug administration to the first documentation of objective tumor regression
Measured: Up to approximately 36 months
Duration of Response (DOR)
DOR: interval from the first documentation of objective tumor regression to the earlier of the first documentation of disease progression or death from any cause
Measured: Up to approximately 36 months
4-month progression-free survival (PFS4)
PFS4: proportion of subjects who are alive and have not experienced disease progression at 4 months after the start of study drug administration
Measured: Up to approximately 36 months
6-month progression-free survival (PFS6)
PFS6: proportion of subjects who are alive and have not experienced disease progression at 6 months after the start of study drug administration
Measured: Up to approximately 36 months
Time to treatment failure (TTF)
TTF: interval from the start of study drug administration to the earliest of the first documentation of disease progression, the permanent cessation of study drug due to an AE, or death from any cause
Measured: Up to approximately 36 months
Overall survival (OS)
OS: interval from the start of study drug administration to death from any cause
Measured: Up to approximately 36 months
Disease benefit ratio (DBR)
DBR: proportion of subjects who experience CR, PR, or stable disease with tumor reduction (SDTR)
Measured: Up to approximately 36 months
Progression free survival (PFS)
PFS: interval from the start of study drug administration to the earlier of the first documentation of disease progression or death from any cause
Measured: Up to approximately 36 months
Duration of disease benefit (DDB)
DDB: interval from the first documentation of objective tumor regression to the earlier of the first documentation of disease progression or death from any cause in subjects with disease benefit
Measured: Up to approximately 36 months
Percent change in tumor dimensions
percent change from baseline in the sum of the longest diameters of non-nodal target lesions and the shortest diameters of nodal target lesions
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start14 May 2025
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In this study, a BOIN design with a target DLT rate for the MTD of 27% and an estimated maximum sample size of \~70 subjects will be used to guide the dose escalation and determine the RDR of SLV-154. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2-stage optimal design.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solve Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771219
- Sponsor's protocol ID
- SLV-154-01Tx
- Status last verified
- Sep 2026
- First submitted
- 3 Jan 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be presented in clinical study reports and publications. Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation/Expansion Study of SLV-154 in Subjects With Advanced Cancers
- ClinicalTrials.gov ID
- NCT06771219
- Acronym / sponsor ID
- SLV-154-01Tx
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Metastatic Cancer
- Keywords
- metastatic solid tumors, metastatic cancer, solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Solve TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Bayesian optimal interval (BOIN) design with a target dose-limiting toxicity (DLT) rate for the maximum tolerated dose (MTD) of 27% and an estimated maximum sample size of ~70 subjects will be used to guide the dose escalation and determine the recommended dosing regimen (RDR) of SLV-154. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2-stage optimal design.
SLV-154 will be administered intravenously (IV) in repeated 3-week cycles. Treatment will continue until progressive disease or discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- In this study, a BOIN design with a target DLT rate for the MTD of 27% and an estimated maximum sample size of ~70 subjects will be used to guide the dose escalation and determine the RDR of SLV-154. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2-stage optimal design.
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: SLV-1540.75 mg/kg |
| Dose Level 2 | Experimental | Drug: SLV-1541.5 mg/kg |
| Dose Level 3 | Experimental | Drug: SLV-1543.0 mg/kg |
| Dose Level 4 | Experimental | Drug: SLV-1544.0 mg/kg |
| Dose Level 5 | Experimental | Drug: SLV-1545.0 mg/kg |
| Dose Level 6 | Experimental | Drug: SLV-1546.5 mg/kg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- Presence of radiographically measurable disease.
Key exclusion criteria (10 listed)
- 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.
- Significant screening ECG abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLV-154SLV-154 | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6 |
Primary outcome
Phase 1a: MTD and/or RDR
Time frame: Through the duration of treatment, up to approximately 18 months
Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-154.
Phase 1b: Objective response rate (ORR)
Time frame: Through the duration of treatment, up to approximately 18 months
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).
15 secondary outcomes
SLV-154 administration
Time frame: Through the duration of treatment, up to approximately 18 months
SLV-154 Safety
Time frame: Through the duration of treatment, up to approximately 18 months
Evaluation of use of concomitant medications
Time frame: Through the duration of treatment, up to approximately 18 months
SLV-154 Pharmacokinetics
Time frame: Varying timepoints through the duration of treatment, up to approximately 18 months
Immunogenicity
Time frame: Varying timepoints through the duration of treatment, up to approximately 18 months
Time to Response (TTR)
Time frame: Up to approximately 36 months
Duration of Response (DOR)
Time frame: Up to approximately 36 months
4-month progression-free survival (PFS4)
Time frame: Up to approximately 36 months
6-month progression-free survival (PFS6)
Time frame: Up to approximately 36 months
Time to treatment failure (TTF)
Time frame: Up to approximately 36 months
Overall survival (OS)
Time frame: Up to approximately 36 months
Disease benefit ratio (DBR)
Time frame: Up to approximately 36 months
Progression free survival (PFS)
Time frame: Up to approximately 36 months
Duration of disease benefit (DDB)
Time frame: Up to approximately 36 months
Percent change in tumor dimensions
Time frame: Up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Results will be presented in clinical study reports and publications. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SLV-154 in people with Advanced Cancer and Advanced Solid Tumor, run by Solve Therapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Ren, MD (425-894-2558, hren@solvetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: MTD and/or RDR (time frame: Through the duration of treatment, up to approximately 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.