SLV-154 Treatment of Advanced Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Advanced Solid Tumor; Advanced Cancer
• Intervention / Treatment: Drug: SLV-154

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Langdon L Miller, MD; Phone Number: 908-906-6471; Email: lmiller@solvetx.com
• Study Contact Backup: Name: Hong Ren, MD; Phone Number: 425-894-2558; Email: hren@solvetx.com

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Hoag Memorial Hospital Presbyterian
      • Contact: Cindy Do, BSN, RN; Phone Number: 949-764-4624; Email: cindy.do@hoag.org
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
      • Contact: Sara Mitchum; Phone Number: 3142738602; Email: saram@wustl.edu
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Astera Cancer Care
      • Contact: Percy Yeung; Phone Number: 732-387-3378; Email: percy.yeung@asterahealthcare.org
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Roisin O'Cearbhaill, MD; Phone Number: 646-888-4227; Email: ocearbhr@mskcc.org
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Afshin Dowlati, MD; Phone Number: 212-844-6031; Email: afshin.dowlati@UHhospitals.org
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Rabia Khan; Phone Number: 713-563-4667; Email: RKhan@mdanderson.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • Oncology Consultants
      • Contact: Julio Peguero, MD; Phone Number: 713-600-0900; Email: jPeguero@oncologyconsultants.com
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Mays Cancer Center; University of Texas Health San Antonio
      • Principal Investigator: Daruka Mahadevan
      • Contact: Daruka Mahadevan, MD; Phone Number: 210-450-1000; Email: mahadevand@uthscsa.edu
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • University of Washington / Fred Hutchinson Cancer Center
      • Contact: Phase 1 Clinical Trials; Phone Number: 206-606-7551; Email: phase1clinicaltrial@fredhutch.org
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties, PLLC
      • Contact: CarrieAnn Brown; Phone Number: 253-428-8700; Email: cbrown@nwmsonline.com
      • Contact: Kiersten Peart; Phone Number: 253-428-8700; Email: kpeart@nwmsonline.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men or women (as appropriate for cancer type) of age ≥12 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Histologically or cytologically confirmed diagnosis of advanced cancer as documented in medical records.
4. Presence of metastatic or recurrent locally advanced cancer.
5. Presence of radiographically measurable disease.
6. 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).
7. 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.
8. 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.
9. 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.
10. Adequate hematological profile.
11. Adequate coagulation profile.
12. Adequate hepatic profile.
13. Adequate renal function.
14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.
15. For female subjects of childbearing potential, a negative serum pregnancy test.
16. 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.
17. 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.
18. 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.
19. 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.

Exclusion Criteria:

1. Unstable malignancy involving the central nervous system.
2. 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.
3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.
4. Significant cardiovascular event or comorbidity.
5. Significant screening ECG abnormalities.
6. Pregnancy or breastfeeding.
7. Major surgery within 3 weeks before the start of study therapy.
8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.
9. Concurrent participation in another therapeutic or imaging clinical trial.
10. Other conditions likely to interfere with a subject's ability to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level 1; 0.75 mg/kg	Drug: SLV-154; SLV-154
Experimental: Dose Level 2; 1.5 mg/kg	Drug: SLV-154; SLV-154
Experimental: Dose Level 3; 3.0 mg/kg	Drug: SLV-154; SLV-154
Experimental: Dose Level 4; 4.0 mg/kg	Drug: SLV-154; SLV-154
Experimental: Dose Level 5; 5.0 mg/kg	Drug: SLV-154; SLV-154
Experimental: Dose Level 6; 6.5 mg/kg	Drug: SLV-154; SLV-154

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: 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
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).	Through the duration of treatment, up to approximately 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLV-154 administration	SLV-154 drug administration as assessed by prescribing records	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	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)	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	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	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	Up to approximately 36 months
Overall survival (OS)	OS: interval from the start of study drug administration to death from any cause	Up to approximately 36 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.	Through the duration of treatment, up to approximately 18 months
SLV-154 Pharmacokinetics	Evaluation of the pharmacokinetic profile of SLV-154	Varying timepoints through the duration of treatment, up to approximately 18 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	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	Up to approximately 36 months
Disease benefit ratio (DBR)	DBR: proportion of subjects who experience CR, PR, or stable disease with tumor reduction (SDTR)	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	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	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	Up to approximately 36 months

Collaborators and Investigators

• Sponsor: Solve Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: metastatic cancer; solid tumor; metastatic solid tumors
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: SLV-154-01Tx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be presented in clinical study reports and publications. Individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No