Study of SMP-3124LP for Advanced Solid Tumors
This study is testing a new drug called SMP-3124LP in adults with advanced solid tumors. This drug is a special formulation of SMP-3124. You might be able to join if you have cancer that has spread or come back, and standard treatments haven't worked or there are no other good options. The main goals are to find a safe dose of SMP-3124LP, see how well people tolerate it, and check if it helps shrink tumors. The study plans to enroll about 120 people. The current recruitment status is unclear.
- Study design
- This is an open-label, Phase 1/2 study, meaning both you and your doctors will know which treatment you are receiving. It is a first-in-human study, designed to evaluate the safety and effectiveness of SMP-3124LP.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for up to 6 months and tumor response for up to 6 months.
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NCT06526819
SMP-3124LP in Adults With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentSumitomo Pharma America, Inc.
~120 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:SMP3124LP
At a glance
Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)
Measured over 28 days
+2 more outcomes measured
Conditions
Where it's being run
12 sites across 9 statesIllinois2
Tennessee2
Japan2
California1
Colorado1
Florida1
Ohio1
Texas1
Study leadership
- Jian Li, MD · STUDY_DIRECTOR · [email protected]
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
ECOG performance \</= 2 at screening
Recovered from any prior treatment related toxicities
Adequate organ function as evidenced by:
Patient is non-fertile or agrees to use adequate methods of contraception or agrees to refrain completely from heterosexual intercourse during the study and for 6 months (for female and male patients alike) after the last dose of study intervention.
May be HIV positive if the following conditions are met:
Known hepatitis B infection mush have negative serum HbsAg. Patients with known hepatitis C virus infection must have a viral load below the limit of quantification Japan sites only: HBc antibody or HBsantibody tests should be performed if HBsAg is negative. If HBc antibody or HBs antibody tests are positive, HBV DNA quantitative tests should be performed to confirm that HBV DNA is negative.
Exclusion
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.
Patient with ovarian cancer
Patient has any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with their participation in the trial or interfere with the interpretation of trial results
Patient is taking a prohibited medication at baseline.
What this trial measures
- Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)28 days
- Number of Participants With Adverse Events and Serious Adverse Events6 months
- Determine the Objective Response Rate (ORR)6 months