OncoMatch/Clinical Trials/NCT05894824

T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Is NCT05894824 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies T-Dxd(Trastuzmab deruxtecan), Ramucirumab for gastric cancer.

Phase 1/2RecruitingYonsei UniversityNCT05894824Data as of May 2026

Treatment: T-Dxd(Trastuzmab deruxtecan), Ramucirumab — This is a Phase Ib/II study to identify the RP2D of T-DXd combination with Ram and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer. The study will be conducted in two parts: Phase Ib dose escalation study to determine the MTD and RP2D of T-DXd combination and Ram, and Phase II to further evaluate the safety and tolerability of T-DXd combinations with Ram at the RP2D and determine anti-tumor activity.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Esophageal Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) low expression (IHC 1+ or IHC 2+ and ISH negative) (IHC 1+ or IHC 2+ and ISH negative)

HER2 low is 1+ by immunohistochemistry (IHC) or 2+ by IHC and without HER2 gene amplification (negative by in situ hybridization [ISH])

Disease stage

Metastatic disease required

Histologically or cytologically proven metastatic or locally advanced HER2 low gastric or GEJ adenocarcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Min 1 prior line

Must have received: chemotherapy — palliative or adjuvant (if recurrence within 6 months)

Progressed after 1st line palliative treatment. Adjuvant chemotherapy will be counted as 1st line treatment if the cancer has recurred within 6 months of completion of adjuvant chemotherapy.

Lab requirements

Blood counts

Absolute neutrophil count ≥1500/mm3; platelets ≥100,000/mm3; hemoglobin ≥9.0 g/dL

Kidney function

Creatinine ≤1.5 × ULN or creatinine clearance >40 ml/min

Liver function

AST and ALT ≤3.0 × ULN (or ≤5.0 × ULN in patients with liver metastases); total bilirubin ≤1.5 × ULN; serum albumin ≥2.5 g/dL

Cardiac function

LVEF ≥ 50% by ECHO or MUGA within 28 days before enrollment; QTcF ≤ 470 msec (females) or ≤450 msec (males)

Adequate baseline organ function defined as: Absolute neutrophil count ≥1500/mm3; Platelets ≥100,000/mm3; Hemoglobin ≥9.0 g/dL; AST and ALT ≤3.0 × ULN (or ≤5.0 × ULN in patients with liver metastases); Total bilirubin ≤1.5 × ULN; Serum albumin ≥2.5 g/dL; Creatinine ≤1.5 × ULN or creatinine clearance >40 ml/min; Urinary protein ≤1+; INR and PTT/aPTT ≤1.5 × ULN; LVEF ≥ 50% by ECHO or MUGA; QTcF ≤ 470 msec (females) or ≤450 msec (males)

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

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