Clinical trial NCT04325711: A Study of CSPCHA131 in Patients With Advanced Solid Tumor
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
timeFrame: Time Frame: 28 days
measure: Incidence of adverse events (AEs) and serious adverse events throughout the trial;
timeFrame: from enrollment to the end of the trial (2 years)
Secondary outcomes:
measure: Objective response rate (ORR) defined by RECIST Criteria Version 1.1;
timeFrame: from enrollment to the end of the trial (2 years)
measure: Progression free survival (PFS) defined by RECIST Criteria Version 1.1;
timeFrame: from enrollment to the end of the trial (2 years)
measure: AUC0-t
timeFrame: 28 days
measure: AUC0-∞
timeFrame: 28 days
measure: Cmax
timeFrame: 28 days
measure: Css_max
timeFrame: 28 days
measure: Css_min
timeFrame: 28 days
measure: DF
timeFrame: 28 days
measure: Ke
timeFrame: 28 days
measure: Tmax
timeFrame: 28 days
measure: Vz
timeFrame: 28 days
measure: T1/2
timeFrame: 28 days
measure: CL
timeFrame: 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: