T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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.
Eligibility criteria
Qualifiers
Able and willing to give written informed consent and has signed the appropriate weitten informed consent form(ICF) prior to performance of any trial activityes.
Eligible male and female subjects aged ≥19 years.
Histologically or cytologically proven metastatic or locally advanced HER2 low gastric or GEJ adenocarcinoma: The definition of HER2 low is 1+ by immunohistochemistry (IHC) or 2+ by IHC and without HER2 gene amplification (negative by in situ hybridization[ISH]).
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.
Disqualifiers
Anticancer treatment within 14 days before the start of trial treatment.
Major surgery within 28 days before the start of trial treatment.
Have received more than 2 prior lines of chemotherapy.
Grade ≥ 2 peripheral neuropathy.
Trial design
Treatments tested in this trial
- T-Dxd(Trastuzmab deruxtecan), Ramucirumab
Treatment groups
58 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov