SMP-3124LP for Cancer

Recruiting at4 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Sumitomo Pharma America, Inc.

Must not be taking: CYP1A2 inhibitors, CYP2D6 inhibitors

Disqualifiers: CNS metastasis, Cardiac disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that patients taking certain strong inhibitors (types of drugs that affect how the body processes medications) must stop them at least 14 days before starting the trial. It's best to discuss your specific medications with the trial team.

Research Team

Jian Li, MD

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for adults with advanced solid tumors who have not responded to standard treatments. Specific eligibility details are not provided, but typically participants must be in good overall health aside from their cancer and able to comply with study requirements.

Inclusion Criteria

My breast cancer is triple negative.

I have recurrent or persistent uterine serous cancer.

For patients in the Dose Expansion Part: Cohort A, B, and C with specific criteria

Exclusion Criteria

I do not have another cancer that could affect this treatment's safety or results.

I am not taking any medication that is not allowed in the study.

Pregnancy or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation & Dose Optimization

Participants receive SMP-3124LP continuous IV infusion every 2 weeks or every 3 weeks, with dose levels ranging from 20 to 120 mg/m2

Varies based on dose escalation

Visits every 2 or 3 weeks

Dose Expansion

Participants receive SMP-3124LP continuous IV infusion at the Recommended Phase 2 Dose

Varies based on treatment response

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• SMP-3124LP (Monoclonal Antibodies)

Trial Overview The trial is testing SMP3124LP's safety, tolerability, and initial effectiveness against solid tumors. It has two parts: the first part tests increasing doses to find the safest dose (Phase 1), and the second part expands on this dose in more patients (Phase 2).

Participant Groups

Group I: Part 2 - Dose Expansion Experimental Treatment 1 Intervention

Patient to receive SMP-3124LP continuous IV infusion at the Recommended Phase 2 Dose as determinated in part 1.

Group II: Part 1 - Dose Escalation & Dose Optimization Experimental Treatment 1 Intervention

Patient to receive SMP-3124LP continuous IV infusion every 2 weeks (q2w) (Schedule 1). At the discretion of the Safety Review Committee (SRC), Schedule 2 - IV infusion every 3 weeks (q3w) - may be initiated for example, after a maximum tolerated dose (MTD) is reached for Schedule 1 (q2w) or when 2 or more patients experience a dose delay of at least 7 days at the same dose level for Schedule 1. The provisional dose levels are 20, 40, 60, 90, and 120 mg/m2, and intermediate and additional dose levels may be added as needed.

Who Is Running the Clinical Trial?

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University