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OncoMatch/Clinical Trials/NCT06526819

SMP-3124LP in Adults With Advanced Solid Tumors

Is NCT06526819 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies SMP3124LP for solid tumor.

Phase 1/2RecruitingSumitomo Pharma America, Inc.NCT06526819Data as of May 2026

Treatment: SMP3124LPAn 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

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: ESR1 negative (< 10% of cells expressing hormonal receptors by IHC) (< 10% of cells expressing hormonal receptors by IHC)

ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines

Required: PR (PGR) negative (< 10% of cells expressing hormonal receptors by IHC) (< 10% of cells expressing hormonal receptors by IHC)

ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors by IHC, as per standard guidelines

Required: HER2 (ERBB2) negative (0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines) (0 or 1+ by IHC, or if IHC 2+, then ISH 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

Disease stage

Required: Stage IV

Metastatic disease required

Grade: Grade 2Grade 3

advanced, recurrent, or metastatic

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy

Platinum resistant is defined as relapsed within 6 months after the last dose of platinum-based therapy

Cannot have received: cell cycle checkpoint inhibitor

Patient has received prior treatment at any time with a cell cycle checkpoint inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)

Lab requirements

Blood counts

Hemoglobin >= 9 g/dL (transfusion or use of erythropoietin to obtain this are not permitted); Absolute neutrophil count >= 1500/uL (platelet transfusion not allowed to achieve this); Platelet count >= 100 x 10^3/uL (platelet transfusion not allowed to achieve this)

Kidney function

Calculated creatinine clearance >= 60 mL/min using Cockcroft-Gault formula

Liver function

Bilirubin <= 1.5 x ULN (or <= 3.0 x ULN if Gilbert's syndrome); AST and ALT <= 3.0 x ULN (or <= 5 x ULN if the liver has tumor involvement)

Cardiac function

Left ventricular ejection fraction >= 45% by echocardiogram (ECHO); no clinically significant cardiac disease including heart failure (NYHA Class III or IV); no abnormal ECG that is clinically significant, including QTcF > 470 msec or history of Torsade de Pointes

Adequate organ function as evidenced by: Hemoglobin >= 9 g/dL... Platelet count >= 100 x 10... Bilirubin <= 1.5 x ULN (or <= 3.0 x if ULN if Gilbert's syndrome) AST and ALT <= 3.0 x ULN (or <= 5 x ULN if the liver has tumor involvement) Calculated creatinine clearance >= 60 mL/min using Cockcroft-Gault formula... abnormal ECG that is clinically significant, including a corrected QT interval (QTcF) > 470 msec; and/or a history of Torsade de Pointes... left ventricular ejection fraction < 45% by echocardiogram (ECHO)... clinically significant cardiac disease including heart failure (NYHA Class III or IV)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Cedars Sinai Medical Center · Los Angeles, California
  • Sarah Cannon Research Institute at HealthOne · Denver, Colorado
  • Northwestern Medicine Cancer Center · Chicago, Illinois
  • Ohio State University · Columbus, Ohio
  • SCRI Oncology Partners · Nashville, Tennessee

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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