SLV-324 for Advanced Cancer

Recruiting at 5 trial locations

Overseen By Hong Ren, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Solve Therapeutics

Must not be taking: CYP3A4 inhibitors, QT prolonging drugs

Disqualifiers: CNS malignancy, Cardiovascular, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 18 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SLV-324 for individuals with advanced cancer that has spread and worsened despite previous treatments. The main goal is to determine the safety of SLV-324 and its effects in the body when administered at different doses through an intravenous (IV) drip. Suitable candidates have a solid tumor that has spread, have tried other treatments, and are willing to undergo regular check-ups and tests. As a Phase 1 trial, this research aims to understand how SLV-324 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs that affect liver enzymes (CYP3A4 or CYP1A2) or drugs that prolong the QT interval (a heart rhythm measure) before starting the study.

Is there any evidence suggesting that SLV-324 is likely to be safe for humans?

Earlier research has tested SLV-324 for safety in humans. Detailed safety information is not yet available, as the study is in its early stages. The primary focus is on determining the treatment's safety and the appropriate dosage. Early studies often assess side effects and how well participants tolerate the treatment.

If the treatment had already been approved for another use, it might suggest some level of safety. However, SLV-324 is still under investigation to understand its effects. Researchers closely monitor participants to address any side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SLV-324 is unique because it introduces a novel approach for treating advanced cancer with its experimental intravenous (IV) infusion method. While most current treatments rely on traditional chemotherapy or targeted therapies, SLV-324 is designed to explore different dose levels, potentially offering a more personalized and effective treatment option. Researchers are particularly excited about SLV-324 because it targets cancer cells in a new way, which could lead to improved outcomes for patients who have not responded well to existing therapies.

What evidence suggests that SLV-324 might be an effective treatment for advanced cancer?

Research shows that SLV-324 is a new treatment being tested for advanced solid tumors in this trial. Although limited data exists on its effectiveness in people, SLV-324 is designed to directly target and attack cancer cells. This method is promising because it aims to stop tumors from growing by disrupting specific processes in cancer cells. Early lab studies suggest it might effectively slow down or stop tumor growth. As ongoing studies progress, more information will emerge about SLV-324's effectiveness. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Adults with metastatic solid tumors who've tried standard treatments can join this trial. They must have measurable disease, be willing to follow the study plan and use contraception. Excluded are those with heart issues, uncontrolled infections, brain cancer unless treated and stable, or on certain drugs affecting metabolism.

Inclusion Criteria

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

Presence of radiographically measurable disease

Exclusion Criteria

I haven't taken any medication that affects heart rhythm in the last week.

I do not have an active infection when starting the study treatment.

I am not taking medication that strongly affects certain liver enzymes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

SLV-324 is administered intravenously in repeated cycles until progressive disease or discontinuation

Up to approximately 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 36 months

What Are the Treatments Tested in This Trial?

Interventions

• SLV-324

Trial Overview

SLV-324 is being tested in a Phase 1 trial for safety and effectiveness in treating metastatic solid tumors. The study will gradually increase doses to find the right balance between benefits and side effects while monitoring how the body processes the drug.

How Is the Trial Designed?

Group I: SLV-324 intravenous (IV infusion) Experimental Treatment 1 Intervention

SLV-324 will be administered at different dose levels in dose-escalation cohorts and at the RDR in dose expansion cohorts

Who Is Running the Clinical Trial?

Solve Therapeutics

Lead Sponsor

Trials

1

Recruited

70+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07108114

SLV-324 Treatment of Metastatic Solid Tumors

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-324 across a range of ...

2.

trialx.com

trialx.com/clinical-trials/listings/324732/slv-324-treatment-of-metastatic-solid-tumors/

SLV-324 Treatment of Metastatic Solid Tumors

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-324 ...

3.

withpower.com

withpower.com/trial/phase-1-solid-metastatic-tumor-7-2025-73cd5

SLV-324 for Advanced Cancer

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-324 across a range of ...

4.

ichgcp.net

ichgcp.net/clinical-trials-registry/547525-slv-324-treatment-of-metastatic-solid-tumors

Experimental Cancer Treatment SLV-324 for Metastatic Solid ...

This clinical trial explores the safety and effectiveness of an experimental drug called SLV-324 for patients with metastatic solid tumors ...

5.

accc-cancer.org

accc-cancer.org/docs/ossn-network/la/meetings/los-2024-cancer-congress-presentations/gastrointestinal-breakthroughs---recent-progress-in-research-and-practice.pdf

Gastrointestinal Breakthroughs

Median follow-up at the data cutoff was 31·0 months (IQR 23·0–38·3). • Median overall survival was longer in the pembrolizumab group than in the placebo group ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07108114

SLV-324 Treatment of Metastatic Solid Tumors

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-324 across a range of ...

7.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0020966

Cancer (DBCOND0020966)

A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer. Sepantronium. basic_science, 1, completed. NCT03326986.