SMP-3124LP for Cancer

Recruiting at 5 trial locations

Overseen By Eileen Maunsell

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sumitomo Pharma America, Inc.

Must not be taking: CYP1A2 inhibitors, CYP2D6 inhibitors

Disqualifiers: CNS metastasis, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new cancer treatment called SMP-3124LP. Researchers are evaluating the safety and effectiveness of this drug for individuals with advanced solid tumors, such as ovarian, breast, lung, and certain head and neck cancers. Participants will receive the treatment through an IV to determine the optimal dosage and assess its impact on the cancer. This trial suits those whose cancer has progressed after standard treatments and who lack other treatment options. 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 this new treatment.

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.

Is there any evidence suggesting that SMP-3124LP is likely to be safe for humans?

Research shows that SMP-3124LP is being tested for safety and effectiveness in treating advanced solid tumors. Early studies have focused on determining the right dose and monitoring side effects. These studies found that patients tolerated different doses well, although some required dose adjustments. No serious safety issues have been reported so far.

Since this trial is in its early stages, it closely monitors any side effects, making patient safety a top priority. Remember, treatments in early trials are still under study for safety. However, initial results suggest that SMP-3124LP is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SMP-3124LP is unique because it is administered as a continuous IV infusion, which is different from many standard cancer treatments that are often given in oral or less frequent infusion forms. This new delivery method might allow for more consistent drug levels in the body, potentially enhancing its effectiveness. Researchers are also excited because SMP-3124LP is undergoing dose optimization, meaning they are fine-tuning the dose to find the most effective and safest way to administer it, which could lead to better outcomes for patients compared to existing treatments.

What evidence suggests that SMP-3124LP might be an effective treatment for advanced solid tumors?

Research has shown that SMP-3124LP may help treat cancer. In early studies, it reduced tumors by more than 40% in half of the tested cases. This trial will evaluate SMP-3124LP using a special delivery method called a liposome, which effectively targets solid tumors. Although still in the early stages, these findings suggest SMP-3124LP could help shrink tumors in patients with advanced solid cancers. ^{1 2 3 6 7}

Who Is on the Research Team?

Jian Li, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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

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

Pregnancy or breastfeeding

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SMP-3124LP

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).

How Is the Trial Designed?

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

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/2903/756700/Abstract-2903-Evaluation-of-SMP-3124-a-novel

Abstract 2903: Evaluation of SMP-3124, a novel liposome ... SMP-3124 showed more than 40% tumor regression relative to baseline in seven out of fourteen of the preclinical patient-derived xenograft models ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2024-06528

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

3. withpower.com withpower.com/trial/phase-2-tumors-solid-7-2024-8edfb

SMP-3124LP for Cancer · Recruiting Participants for Phase ... Trial Overview The trial is testing SMP3124LP's safety, tolerability, and initial effectiveness against solid tumors. It has two parts: the first part tests ...

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/smp-3124-sumitomo-pharma-triple-negative-breast-cancer-tnbc-likelihood-of-approval/

SMP-3124 by Sumitomo Pharma for Triple-Negative Breast ... According to GlobalData, Phase II drugs for Triple-Negative Breast Cancer (TNBC) have a 24% phase transition success rate (PTSR) indication ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=cf7e4caf-5b04-4eac-bacd-f39bff3f55b0

SMP-3124 / Sumitomo Pharma - Ovarian Cancer A novel CHK1 inhibitor encapsulated within the liposome, SMP-3124, for the treatment of solid cancer (AACR 2024)

6. synapse.patsnap.com synapse.patsnap.com/drug/36ae05f1613c44f5b9d75939ed8278db

SMP-3124 - Drug Targets, Indications, Patents An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity ...

7. healthscout.app healthscout.app/trial_match/view_trial/NCT06526819/

Trial: SMP-3124LP in Adults With Advanced Soli… Goal: The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SMP-3124LP, a novel CHK1 inhibitor, in adults ...