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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: IBI130 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : November 14, 2023
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : October 31, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: IBI130
IBI130
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT05923008


Contacts
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Contact: Serena Dong 0512 69566088 suhua.dong@innoventbio.com

Locations
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Australia, Queensland
Sunshine Coast University Recruiting
Birtinya, Queensland, Australia, 4575
Contact: Michelle Morris    07 53906057    morrismi2@ramsayhealth.com.au   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT05923008    
Other Study ID Numbers: CIBI130A101
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: November 29, 2023
Last Verified: November 2023

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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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Neoplasms