A Study of CSPCHA131 in Patients With Advanced Solid Tumor

Phase 1

• Conditions: Advanced Solid Tumors
• Interventions: Drug: CSPCHA131

• Registration Number: NCT04325711
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-30
• Study Start: 2020-04-24
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CSPCH131 dose Escalation and expansion	CSPCHA131	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
Css_max	28 days	PK parameter: Css_max
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.
AUC0-t	28 days	PK parameter: AUC0-t
AUC0-∞	28 days	PK parameter: AUC0-∞
Cmax	28 days	PK parameter: Cmax
Css_min	28 days	PK parameter: Css_min
Ke	28 days	PK parameter: Ke
DF	28 days	PK parameter: DF
Vz	28 days	PK parameter: Vz
T1/2	28 days	PK parameter: T1/2
CL	28 days	PK parameter: CL
Tmax	28 days	PK parameter: Tmax

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China