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SMP-3124LP in Adults With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

SMP-3124LP in Adults With Advanced Solid Tumors

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

NCT06526819•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

Phase 1/2, global, multicenter, open-label, first-in-human, clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of SMP-3124

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- Histologically or cytologically-confirmed cancer that is advanced, recurrent, or metastatic with the following origins, and whose disease progressed on standard therapy and for whom there are no alternative therapies that may confer overall survival benefit.
•For patients in the Dose Escalation part:
•1. Platinum-resistant ovarian cancer
•* Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer, with predominantly high-grade (Grade 2 or 3) epithelial features (serous and clear cell)
•* Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy
•2. Triple negative breast cancer - ER- and PR-negative with HER2 negative
•* HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
•* ER- and PR-negative is defined as \< 10% of cells expressing hormonal receptors by IHC, as per standard guidelines
•3. Squamous cell carcinoma of the anus
•\- Patient with locally advanced ineligible for surgery is allowed.
+17 more criteria

Exclusion Criteria

•Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
•Patient has a known allergy or sensitivity to any component of SMP-3124LP, including the inactive ingredients
•Patient has received treatment with systemic anticancer therapy, radiotherapy, or investigational therapy within 14 days prior to Study Cycle 1 Day 1. (Palliative radiotherapy with a limited field of radiation within 2 weeks will be permitted.)
•Patient has undergone a major surgical procedure ≤ 28 days, or minor surgical procedure ≤ 7 days, prior to Cycle 1 Day 1
•Patient has used strong CYP1A2 or 2D6 inhibitors within 14 days or 5 half-lives, whichever occurs first, prior to Cycle 1 Day 1 (examples of restricted CYP1A2 and CYP2D6, P-gp, and/or BCRP inducers, inhibitors, or substrates are presented in Table 16)
•Patient has central nervous system metastasis or leptomeningeal disease
•Prior or concurrent malignancy whose natural history or treatment would have a significant potential to interfere with the safety or efficacy assessments of the investigational regimen
•Patient has an abnormal ECG that is clinically significant, including a corrected QT interval (corrected using Fridericia's correction formula \[QTcF\]) \> 470 msec; and/or a history of Torsade de Pointes
•Patient has a left ventricular ejection fraction \< 45% by echocardiogram (ECHO)
•Patient has clinically significant cardiac disease including heart failure (eg, New York Heart Association, Class III or IV)
+8 more criteria

Locations (10)

Cedars Sinai Medical Center

Los Angeles, California, United States

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States

Northwestern Medicine Cancer Center

Chicago, Illinois, United States

Ohio State University

Columbus, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

National Cancer Center Hospital East

Kashiwa-shi, Japan

Kyoto University Hospital

Kyoto, Japan

Key Dates

Start Date

August 14, 2024

Primary Completion Date

December 1, 2028

Completion Date

May 1, 2029

Last Updated

February 27, 2026

Enrollment

120

ESTIMATED participants

Conditions

Solid Tumor

Interventions

SMP3124LP

DRUG

Contacts

Eileen Maunsell

CONTACT

774-405-5069 eileen.maunsell@us.sumitomo-pharma.com

Shuichi Iino

CONTACT

508-481-6700 shuichi.iino@us.sumitomo-pharma.com

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SMP-3124LP in Adults With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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