A Study of CSPCHA131 in Patients With Advanced Solid Tumor

Study 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.

Official Title
-----------------
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of CSPCHA131 in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: CSPCHA131


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSPCH131 dose Escalation and expansion<br>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. | Drug: CSPCHA131<br>* CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) defined by RECIST Criteria Version 1.1; | ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR). | from enrollment to the end of the trial (2 years) | 
| Progression free survival (PFS) defined by RECIST Criteria Version 1.1; | PFS is defined as the time from the start of treatment until disease progression or death from any cause, whichever is earlier. | from enrollment to the end of the trial (2 years) | 
| AUC0-t | PK parameter: AUC0-t | 28 days | 
| AUC0-∞ | PK parameter: AUC0-∞ | 28 days | 
| Cmax | PK parameter: Cmax | 28 days | 
| Css_max | PK parameter: Css_max | 28 days | 
| Css_min | PK parameter: Css_min | 28 days | 
| DF | PK parameter: DF | 28 days | 
| Ke | PK parameter: Ke | 28 days | 
| Tmax | PK parameter: Tmax | 28 days | 
| Vz | PK parameter: Vz | 28 days | 
| T1/2 | PK parameter: T1/2 | 28 days | 
| CL | PK parameter: CL | 28 days |