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
1 other identifier
interventional
120
2 countries
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2024
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedStudy Start
First participant enrolled
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
February 27, 2026
February 1, 2026
4.3 years
July 24, 2024
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)
28 days
Number of Participants With Adverse Events and Serious Adverse Events
6 months
Determine the Objective Response Rate (ORR)
6 months
Secondary Outcomes (3)
The maximum concentration (Cmax) of SMP-3124 and SMP-3124LP
6 months
The area under the curve (AUC) of SMP-3124 and SMP-3124LP
6 months
The duration of response (DOR) assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
6 months
Study Arms (2)
Part 1 - Dose Escalation & Dose Optimization
EXPERIMENTALPatient 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.
Part 2 - Dose Expansion
EXPERIMENTALPatient to receive SMP-3124LP continuous IV infusion at the Recommended Phase 2 Dose as determinated in part 1.
Interventions
Liposomal encapsulation formulation of SMP-3124
Eligibility Criteria
You may qualify if:
- \- 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:
- 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
- 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
- Squamous cell carcinoma of the anus
- \- Patient with locally advanced ineligible for surgery is allowed.
- Squamous cell carcinoma of the head and neck
- Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell carcinoma)
- Uterine serous cancer (recurrent or persistent)
- For Patients in the Dose Expansion Part:
- Cohort A: PROC (same as above)
- +12 more criteria
You may not qualify if:
- 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)
- Patient has an active, uncontrolled, bacterial, viral, or fungal infection requiring parenteral antimicrobial within 1 weeks prior to Cycle 1 Day 1
- Patient is pregnant (as evidenced by a positive serum or urine pregnancy test) or is breastfeeding. Female breastfeeding patients may be enrolled if they interrupt breastfeeding. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug.
- For sites in Japan only: In addition to the above, any patient deemed likely to be pregnant based on medical interview will be excluded from the study.
- Patient with ovarian cancer
- Has a history of bowel obstruction related to their underlying disease within 3 months prior to Study Day 1
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218, United States
Northwestern Medicine Cancer Center
Chicago, Illinois, 60611, United States
Ohio State University
Columbus, Ohio, 43210, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98105, United States
National Cancer Center Hospital East
Kashiwa-shi, 277-8577, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jian Li, MD
jian.li@us.sumitomo-pharma.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2024
First Posted
July 30, 2024
Study Start
August 14, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share