A Study of CSPCHA131 in Patients With Advanced Solid Tumor

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325711
• Other study ID #: CSPCHA131-CSP-001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 24, 2020
• Est. completion date: April 12, 2021

Study information

• Verified date: March 2020
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Xiugao Yang
• Phone: +86 02160677906
• Email: yangxiugao[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 12, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• CSPCHA131
CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.		Time Frame: 28 days
Primary	Incidence of adverse events (AEs) and serious adverse events throughout the trial;		from enrollment to the end of the trial (2 years)
Secondary	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)
Secondary	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)
Secondary	AUC0-t	PK parameter: AUC0-t	28 days
Secondary	AUC0-8	PK parameter: AUC0-8	28 days
Secondary	Cmax	PK parameter: Cmax	28 days
Secondary	Css_max	PK parameter: Css_max	28 days
Secondary	Css_min	PK parameter: Css_min	28 days
Secondary	DF	PK parameter: DF	28 days
Secondary	Ke	PK parameter: Ke	28 days
Secondary	Tmax	PK parameter: Tmax	28 days
Secondary	Vz	PK parameter: Vz	28 days
Secondary	T1/2	PK parameter: T1/2	28 days
Secondary	CL	PK parameter: CL	28 days