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Trial record 1 of 1 for:    CIBI130A101
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A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05923008
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : November 29, 2023
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Tracking Information
First Submitted Date  ICMJE June 19, 2023
First Posted Date  ICMJE June 28, 2023
Last Update Posted Date November 29, 2023
Actual Study Start Date  ICMJE November 14, 2023
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2023)		 Adverse events (AEs) [ Time Frame: Up to 30 days post last dose ]
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2023)
  • objective response rate (ORR) [ Time Frame: Time from first dose to best response to treatment, assessed up to 3 years ]
    ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria
  • duration of response(DoR) [ Time Frame: Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years ]
    For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death
  • overall survival (OS) [ Time Frame: Time from first dose to death, assessed up to 3 years ]
    Time from the date of the first dose to death of the subject due to any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2023)
  • objective response rate (ORR) [ Time Frame: Time from first dose to best response to treatment, assessed up to 3 years ]
    ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria
  • duration of response(DoR) [ Time Frame: Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years ]
    For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death
  • overall survival (OS) [ Time Frame: Time from first dose to death, assessed up to 3 years ]
    Time from the date of the first dose to death of the subject due to any cause
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Brief Summary This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: IBI130
Subjects will receive IBI130 until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
Study Arms  ICMJE Experimental: IBI130
IBI130
Intervention: Drug: IBI130
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2023)		 182
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2026
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
  2. Male or female subjects ≥ 18 years old;
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  4. Anticipated life expectancy of ≥ 12 weeks;
  5. Adequate bone marrow and organ function

Exclusion Criteria:

  1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
  2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
  3. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
  4. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Serena Dong 0512 69566088 suhua.dong@innoventbio.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05923008
Other Study ID Numbers  ICMJE CIBI130A101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Innovent Biologics (Suzhou) Co. Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Innovent Biologics (Suzhou) Co. Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innovent Biologics (Suzhou) Co. Ltd.
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP