Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CM082 combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy. In the subsequent dose expansion part, additional subjects will be enrolled to further explore the safety and preliminary clinical activity of CM082 and paclitaxel.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AnewPharma
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Fully understand the study and sign the informed consent voluntarily;

• Patients with local advanced and/or metastatic gastric adenocarcinoma and/or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;

• Progressed on previous first-line standard chemotherapy;

• Male or female with an age of 18-70 years(inclusive);

• Body weight ≥40 kg (inclusive);

• At least one measurable lesion (according to RECIST1.1);

• Performance status score (ECOG score) 0-1;

• Expected survival >12 weeks;

• Adequate bonemarrow, liver, renal and cardiac function, based on blood tests, electrocardiograms, and cardiac echocardiograms.

Exclusion Criteria:

• Participating in another drug clinical trial in the past 4 weeks; history of systemic anti-tumor treatment within 4 weeks prior to administration of the study drug; history of any major surgery within 4 weeks prior to enrollment to the study;

• Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE>grade 1), or not completely recovered from previous surgery;

• Having received previous chemotherapy regimens with taxanes;

• Take medications that may extend QTc and/or Tdp;

• Active brain metastasis or meningeal metastasis;

• Uncontrolled hypertension (BP>150/90 on medications);

• Other malignancies within the last 5 years, except for adequately treated cervix carcinoma in situ or basal or squamous-cell or basal cell carcinoma;

• QT interval > 450 ms;

• Uncontrolled clinical active infection, e.g. acute pneumonia, active hepatitis B or hepatitis C; HIV positive; syphilitic spiral antibody positive;

• Dysphagia, intractable vomiting or known drug malabsorption;

• Drug or alcohol abuser.