OncoMatch/Clinical Trials/NCT06873659
SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
Is NCT06873659 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SON-DP for solid tumor.
Treatment: SON-DP — A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced Solid Tumors
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Gastric Cancer
Hepatocellular Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
advanced primary liver cancer; Advanced primary gastric cancer (including gastroesophageal junction adenocarcinoma); at least one measurable lesion defined by RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anticancer therapy
Anticancer therapy within 5 half-lives or 3 weeks (whichever is shorter) prior to study entry. Chinese anticancer medicine, three weeks prior first dosing.
Cannot have received: interventional, investigational study
Participation in an interventional, investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
Cannot have received: radical radiation therapy or radiation to an area where the bone marrow proportion is greater than 30%
Exception: palliative radiation therapy for localized lesions or local interventional treatments assessed by the investigator as posing no safety risks
Received radical radiation therapy or radiation to an area where the bone marrow proportion is greater than 30% within 4 weeks prior to the first dose of SON-DP. Exceptions include: palliative radiation therapy for localized lesions (e.g., radiation therapy for bone lesions aimed at symptom relief) or local interventional treatments (such as transarterial chemoembolization [TACE] and others) assessed by the investigator as posing no safety risks.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Hemoglobin (HGB) ≥ 80 g/L; Platelet count (PLT) ≥ 75 × 10⁹/L; no blood transfusions or hematopoietic growth factor support within 14 days prior to first dose
Kidney function
Blood Urea Nitrogen (BUN) < 2.5×ULN; calculated creatinine clearance (CrCL) ≥ 60 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤ 1.5 × ULN (except Gilbert's syndrome, excluded if TBIL > 3.0×ULN or direct bilirubin < 1.5×ULN); AST < 3.0×ULN (≤ 5×ULN if liver involvement); ALT ≤ 3.0×ULN (≤ 5×ULN if liver involvement); no evidence of sustained liver function elevation (within 7 days) or acute hepatic decompensation
Cardiac function
No clinically significant and/or uncontrolled heart disease (NYHA ≥ 2), LVEF < 50%, uncontrolled hypertension, clinically significant arrhythmia, QTcF > 470 ms (except pacemaker), acute MI or unstable angina < 6 months prior to entry
Adequate hepatic/renal function as evidenced by meeting all the following requirements... The subject must have adequate bone marrow function... Coagulation tests within an acceptable range... Impaired cardiac function or clinically significant cardiac disease, including any of the following...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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