SLV-154 Treatment of Advanced Cancers

NCT06771219 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SLV-154-01Tx
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Advanced Cancer; Advanced Solid Tumor; Metastatic Cancer

Keywords

metastatic solid tumors; metastatic cancer; solid tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• 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

Study Arms (6)

Dose Level 1

EXPERIMENTAL

0.75 mg/kg

Drug: SLV-154

Dose Level 2

EXPERIMENTAL

1.5 mg/kg

Drug: SLV-154

Dose Level 3

EXPERIMENTAL

3.0 mg/kg

Drug: SLV-154

Dose Level 4

EXPERIMENTAL

4.0 mg/kg

Drug: SLV-154

Dose Level 5

EXPERIMENTAL

5.0 mg/kg

Drug: SLV-154

Dose Level 6

EXPERIMENTAL

6.5 mg/kg

Drug: SLV-154

Interventions

SLV-154 DRUG

SLV-154

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5; Dose Level 6

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Solve Therapeutics: lead

Study Sites (10)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Oncology Consultants

Houston, Texas, 77030, United States

RECRUITING

Mays Cancer Center; University of Texas Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

University of Washington / Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hong Ren, MD

CONTACT

425-894-2558; hren@solvetx.com

Langdon L Miller, MD

CONTACT

908-906-6471; lmiller@solvetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 13, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)