OncoMatch/Clinical Trials/NCT07309770
Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies
Is NCT07309770 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SHR-A1811 and Trastuzumab Rezetecan for urachal cancer.
Treatment: SHR-A1811 · Trastuzumab Rezetecan — This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg/kg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression (HER2 ≥ 1+ by immunohistochemistry [IHC]) (HER2 ≥ 1+ by IHC)
pathologically confirmed as HER2-positive (i.e., HER2 ≥ 1+ by immunohistochemistry [IHC])
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: PD-1/PD-L1 inhibitor combined with enfortumab vedotin or disitamab vedotin (enfortumab vedotin, disitamab vedotin) — first-line
disease progression following first-line treatment with a PD-1/PD-L1 inhibitor combined with enfortumab vedotin or disitamab vedotin
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 70 × 10⁹/L; Hemoglobin ≥ 80 g/L
Kidney function
Serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
Serum total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN (≤ 5 × ULN if liver metastases are present); serum albumin ≥ 28 g/L
Hematological function: ANC ≥ 1.5 × 10⁹/L, Platelet count ≥ 70 × 10⁹/L, Hemoglobin ≥ 80 g/L; Hepatic function: TBIL ≤ 1.5 × ULN, ALT/AST ≤ 3 × ULN (≤ 5 × ULN if liver metastases), albumin ≥ 28 g/L; Renal function: Cr ≤ 1.5 × ULN or CrCl ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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