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 (Jun 2026). This Phase 1/2 trial studies T-Dxd(Trastuzmab deruxtecan), Ramucirumab for gastric cancer.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT05894824 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemotherapy.
Does this trial require ERBB2?
Yes, ERBB2 low expression (IHC 1+ or IHC 2+ and ISH negative) is a required biomarker for enrollment.
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