A Study of CSPCHA131 in Patients With Advanced Solid Tumor

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: CSPCHA131

Study type: Interventional

Funder types: Industry

Identifiers

NCT04325711

CSPCHA131-CSP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CSPCH131 dose Escalation and expansion

Experimental group

Description:

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.

Treatment:

Drug: CSPCHA131