A Study of CSPCHA131 in Patients With Advanced Solid Tumor

• Status: Recruiting
• Trial end date: 2021-04-12
• Target enrollment: 0
• Participant gender: All

Summary

The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors.

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

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Criteria

Inclusion Criteria:

• 1.18-75 years of age.

• 2. Histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumors, for which standard therapy either does not exist or has been proven ineffective or intolerable for the patient.

• 3. At least one measurable tumor lesion according to RECIST version 1.1.

• 4. ECOG performance status of 0 or 1.

• 5. Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline.

Exclusion Criteria:

• 1. Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, other anti-tumor treatments or an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of study treatment.

• 2. Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure.

• 3. Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less.

• 4. Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment.

• 5. Active infections of grade 2 or above.

• 6. Peripheral neuropathy of grade 2 or above.