SLV-154 for Advanced Cancer

Recruiting at 8 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 aims to test the safety and effectiveness of a new treatment called SLV-154, a potential drug for people with advanced cancer that has spread. Researchers are exploring different doses of SLV-154 to determine the best and safest amount for patients. This trial suits individuals whose cancer has continued to grow despite previous treatments and have tumors measurable by scans. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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-154 is likely to be safe for humans?

Research has shown that SLV-154 is being tested in early studies to assess its safety for treating advanced cancer. This is a Phase 1 study, aiming to evaluate patient tolerance and determine the appropriate dose. This phase typically involves a small number of participants and prioritizes safety over efficacy.

As SLV-154 remains in early testing, detailed safety information is not widely available. However, Phase 1 studies are designed to closely monitor patients for side effects and ensure the treatment's safety. Although the treatment is experimental, participants will be carefully observed for any potential side effects.

If SLV-154 demonstrates positive results and is well-tolerated in these initial studies, it may proceed to further testing. Participants in this study will help researchers understand how the treatment functions in the body and identify possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SLV-154 because it targets advanced cancer differently than current treatments. Unlike traditional chemotherapy and radiation, which attack both cancerous and healthy cells, SLV-154 is designed to hone in on tumor cells specifically, potentially reducing side effects. Additionally, SLV-154's unique mechanism of action involves a novel pathway that may enhance the body's immune response against cancer. This targeted approach not only promises to be more effective but also aims to improve the quality of life for patients by minimizing collateral damage to healthy tissues.

What evidence suggests that SLV-154 might be an effective treatment for advanced cancer?

Initial findings suggest that SLV-154 may help treat advanced solid tumors by boosting the body's immune response against cancer cells. Research has shown that this treatment strengthens the body's natural defenses, enhancing its ability to find and destroy cancer cells. Although detailed information on its effectiveness remains limited, early studies are promising. This trial tests SLV-154 at different doses to determine the safest and most effective amount. The treatment aims to shrink tumors, and early signs are hopeful. Ongoing research will provide more definitive results. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with certain metastatic solid tumors (like cancers of the head, neck, lung, breast, cervix, endometrium, ovary or bladder) can join this trial. They should be relatively active and able to care for themselves (ECOG status 0-2).

Inclusion Criteria

My condition is non-small cell lung cancer.

I have endometrial cancer.

I have ovarian cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

SLV-154 is administered intravenously in repeated 3-week 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 18 months

Long-term follow-up

Monitoring of overall survival and progression-free survival

Up to approximately 36 months

What Are the Treatments Tested in This Trial?

Interventions

• SLV-154

Trial Overview The trial is testing SLV-154's safety and effectiveness in various doses on patients with advanced cancer. It's an early-stage study to see how the body reacts to the drug and what it does to the tumor.

How Is the Trial Designed?

Group I: Dose Level 8 Experimental Treatment 1 Intervention

15.0 mg/kg

Group II: Dose Level 7 Experimental Treatment 1 Intervention

12.5 mg/kg

Group III: Dose Level 6 Experimental Treatment 1 Intervention

10.0 mg/kg

Group IV: Dose Level 5 Experimental Treatment 1 Intervention

7.5 mg/kg

Group V: Dose Level 4 Experimental Treatment 1 Intervention

5.0 mg/kg

Group VI: Dose Level 3 Experimental Treatment 1 Intervention

3.0 mg/kg

Group VII: Dose Level 2 Experimental Treatment 1 Intervention

1.5 mg/kg

Group VIII: Dose Level 1 Experimental Treatment 1 Intervention

0.75 mg/kg

Who Is Running the Clinical Trial?

Solve Therapeutics

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06771219

SLV-154 Treatment of Metastatic Solid Tumors This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of ...

2. trial.medpath.com trial.medpath.com/clinical-trial/401f63e2028b5027/nct06771219-slv-154-metastatic-solid-tumors

SLV-154 Treatment of Metastatic Solid Tumors - MedPath This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of ...

3. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15414.slv-154-treatment-of-metastatic-solid-tumors.html

SLV-154 Treatment of Metastatic Solid Tumors This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 ...

4. cancer.gov cancer.gov/research/participate/clinical-trials/disease/cervical-cancer?pn=1

Cervical Cancer Clinical Trials - NCI NCI supports clinical trials studying new and more effective ways to detect and treat cancer ... SLV-154 Treatment of Metastatic Solid Tumors. Status: Active.

5. facingourrisk.org facingourrisk.org/research-clinical-trials/results?amp%3Bkeyword=&amp%3Bstage=&amp%3Bstudy_type=treatment&amp%3Btest_marker=&cancer_type=endometrial

Research & Clinical Trials Search Results: Endometrial ... This study will test the safety and effectiveness of using a new immunotherapy drug called NC410 to treat people with different types of metastatic or advanced ...

6. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2025-0065.html

A phase 1 dose-escalation study of SLV-154 in subjects ... This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of ...

7. healthscout.app healthscout.app/trial_match/view_trial/NCT06771219/?back=/trial_match/view_trials/condition/breast/%3Fpage%3D30

Trial: SLV-154 Treatment of Metastatic Solid T… - HealthScout Goal: Determine the safety profile, maximum tolerated dose, and recommended dosing regimen of SLV-154 in adults with metastatic solid tumors, ...