A Study of CSPCHA131 in Patients With Advanced Solid Tumor

NCT04325711 | Unknown Phase 1

• 1 other identifier: CSPCHA131-CSP-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Objective response rate (ORR) defined by RECIST Criteria Version 1.1;

  from enrollment to the end of the trial (2 years)

• Progression free survival (PFS) defined by RECIST Criteria Version 1.1;

  from enrollment to the end of the trial (2 years)

• AUC0-t

  28 days

• AUC0-∞

  28 days

• Cmax

  28 days

Study Arms (1)

CSPCH131 dose Escalation and expansion

EXPERIMENTAL

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

Interventions

CSPCHA131 DRUG

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

CSPCH131 dose Escalation and expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• \. 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.
• \. At least one measurable tumor lesion according to RECIST version 1.1.
• \. ECOG performance status of 0 or 1.
• \. Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline.

You may not qualify if:

• \. 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.
• \. Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure.
• \. Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less.
• \. Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment.
• \. Active infections of grade 2 or above.
• \. Peripheral neuropathy of grade 2 or above.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Central Study Contacts

Xiugao Yang

CONTACT

+86 02160677906; yangxiugao@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 30, 2020
• Study Start: April 24, 2020
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: January 6, 2021

Record last verified: 2020-03

Locations

CN (1)