SLV-154 for Advanced Cancer

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+