Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

The trial consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (proof-of-concept study). Among them, Stage 2 adopts a randomized, controlled, open-label, and multicenter design.

Eligibility criteria

Qualifiers

1. Patients who are able to understand and voluntarily sign the written ICF;

2. Male or female patients aged ≥ 18 years (inclusive);

3. Patients with advanced solid tumors diagnosed by pathology or cytology;

4. Patients with a past medical history showing either negative or positive Her-2 expression can be enrolled. For those with unknown Her-2 expression, the Her-2 status needs to be determined before enrollment. For patients with positive Her-2 expression, their previous treatments should include anti-Her-2 drug therapy.

Disqualifiers

1. Patients with prior treatment with targeted MET drugs;

2. Previous treatments included docetaxel;

3. Patients with meningeal metastases, spinal cord compression, symptomatic or progressive brain metastases are not eligible for enrollment.

4. Known hypersensitivity or intolerable conditions to any component of the drugs in the study protocol or their excipients.

Trial design

Treatments tested in this trial

  • Glumetinib Tablets
  • Docetaxel for Injection (Albumin-bound)

Treatment groups

350 Participants
are divided into 2 treatment groups