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A Study of CSPCHA131 in Patients With Advanced Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04325711
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: CSPCHA131 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 12, 2020
Estimated Primary Completion Date : April 12, 2021
Estimated Study Completion Date : April 12, 2021

Arm Intervention/treatment
Experimental: CSPCH131 dose Escalation and expansion
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
CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle.

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level. [ Time Frame: Time Frame: 28 days ]
  2. Incidence of adverse events (AEs) and serious adverse events throughout the trial; [ Time Frame: from enrollment to the end of the trial (2 years) ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) defined by RECIST Criteria Version 1.1; [ Time Frame: 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).

  2. Progression free survival (PFS) defined by RECIST Criteria Version 1.1; [ Time Frame: 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.

  3. AUC0-t [ Time Frame: 28 days ]
    PK parameter: AUC0-t

  4. AUC0-∞ [ Time Frame: 28 days ]
    PK parameter: AUC0-∞

  5. Cmax [ Time Frame: 28 days ]
    PK parameter: Cmax

  6. Css_max [ Time Frame: 28 days ]
    PK parameter: Css_max

  7. Css_min [ Time Frame: 28 days ]
    PK parameter: Css_min

  8. DF [ Time Frame: 28 days ]
    PK parameter: DF

  9. Ke [ Time Frame: 28 days ]
    PK parameter: Ke

  10. Tmax [ Time Frame: 28 days ]
    PK parameter: Tmax

  11. Vz [ Time Frame: 28 days ]
    PK parameter: Vz

  12. T1/2 [ Time Frame: 28 days ]
    PK parameter: T1/2

  13. CL [ Time Frame: 28 days ]
    PK parameter: CL

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04325711

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Contact: Xiugao Yang +86 02160677906

Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Identifier: NCT04325711    
Other Study ID Numbers: CSPCHA131-CSP-001
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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