OncoMatch/Clinical Trials/NCT06526819
SMP-3124LP in Adults With Advanced Solid Tumors
Is NCT06526819 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies SMP3124LP for solid tumor.
Treatment: SMP3124LP — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
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 →Frequently asked questions
Is NCT06526819 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cell cycle checkpoint inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 negative (< 10% of cells expressing hormonal receptors by IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative (< 10% of cells expressing hormonal receptors by IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (0 or 1+ by IHC, or if IHC 2+, then in situ hybridization is negative per the ASCO-CAP HER2 guidelines) is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify