Advanced Solid Tumors
Conditions
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.
Interventions
DRUGCSPCHA131
CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle.
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level. | Time Frame: 28 days |
| Incidence of adverse events (AEs) and serious adverse events throughout the trial; | from enrollment to the end of the trial (2 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | 28 days | PK parameter: AUC0-t |
| AUC0-∞ | 28 days | PK parameter: AUC0-∞ |
| Cmax | 28 days | PK parameter: Cmax |
| Css_max | 28 days | PK parameter: Css\_max |
| Css_min | 28 days | PK parameter: Css\_min |
| Objective response rate (ORR) defined by RECIST Criteria Version 1.1; | from enrollment to the end of the trial (2 years) | ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR). |
| Ke | 28 days | PK parameter: Ke |
| Tmax | 28 days | PK parameter: Tmax |
| Vz | 28 days | PK parameter: Vz |
| T1/2 | 28 days | PK parameter: T1/2 |
| CL | 28 days | PK parameter: CL |
| DF | 28 days | PK parameter: DF |
| Progression free survival (PFS) defined by RECIST Criteria Version 1.1; | from enrollment to the end of the trial (2 years) | PFS is defined as the time from the start of treatment until disease progression or death from any cause, whichever is earlier. |
Countries
China
Contacts
Primary ContactXiugao Yang
Outcome results
None listed