A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of CSPCHA131 in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- CSPCHA131
- Conditions
- Advanced Solid Tumors
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
This is a dose escalation and expansion study with the aim to evaluate and characterize the tolerability and safety profile of CSPCHA131 alone (Stage I) or plus chemotherapy (Stage II) in patients with advanced solid tumors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.18-75 years of age.
- •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.
- •At least one measurable tumor lesion according to RECIST version 1.
- •ECOG performance status of 0 or
- •Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline.
Exclusion Criteria
- •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.
- •Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure.
- •Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less.
- •Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment.
- •Active infections of grade 2 or above.
- •Peripheral neuropathy of grade 2 or above.
Arms & Interventions
CSPCH131 dose Escalation and expansion
In the dose escalation part of Stage I, five dose levels will be tested according to the "3 + 3" dose-escalation design. Whether and how to carry out the follow-up study parts will be decided by the PI and sponsor on the basis of the achieved results of safety, tolerability and effectiveness of CSPCHA131.
Intervention: CSPCHA131
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
Time Frame: Time Frame: 28 days
Incidence of adverse events (AEs) and serious adverse events throughout the trial;
Time Frame: from enrollment to the end of the trial (2 years)
Secondary Outcomes
- Cmax(28 days)
- Css_min(28 days)
- Objective response rate (ORR) defined by RECIST Criteria Version 1.1;(from enrollment to the end of the trial (2 years))
- Css_max(28 days)
- Progression free survival (PFS) defined by RECIST Criteria Version 1.1;(from enrollment to the end of the trial (2 years))
- AUC0-t(28 days)
- AUC0-∞(28 days)
- Ke(28 days)
- DF(28 days)
- Vz(28 days)
- T1/2(28 days)
- CL(28 days)
- Tmax(28 days)