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Trial record 1 of 1 for:    CIBI334A101
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IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05774873
Recruitment Status : Recruiting
First Posted : March 20, 2023
Last Update Posted : November 28, 2023
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
The primary objective of this study to evaluate the safety and tolerability of IBI334 and determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI334.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: IBI334 D Drug: IBI334 C Drug: IBI334 A Drug: IBI334 B Drug: IBI334 F Drug: IBI334 E Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : August 9, 2023
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : June 30, 2026

Arm Intervention/treatment
Experimental: IBI334 E Drug: IBI334 E
Subjects will receive IBI334 C once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Experimental: IBI334 D Drug: IBI334 D
Subjects will receive IBI334 D once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Experimental: IBI334 C Drug: IBI334 C
Subjects will receive IBI334 C once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Experimental: IBI334 A Drug: IBI334 A
Subjects will receive IBI334 A once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Experimental: IBI334 F Drug: IBI334 F
Subjects will receive IBI334 F once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.

Experimental: IBI334 B Drug: IBI334 B
Subjects will receive IBI334 B once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals recommended by the Investigator and Sponsor based on safety, toxicity and PK data), until disease progression, toxicity intolerance, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaches 24 months, whichever occurs first.




Primary Outcome Measures :
  1. Number of patients with treatment-related adverse events [ Time Frame: Up to 60 days post last dose ]
    Number of patients who experienced a treatment related AEs from the first dose until 60 days after the last dose

  2. Percentage of subjects woth Dose-Limitine toxicities(DLTs) [ Time Frame: Up to 28 days following first dose ]
    To evaluate the safety and tolerability of IBI334


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 60 days post last dose ]
    Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response(PR) assessed per RECIST v1.1 criteria .

  2. Duration of response (DoR) [ Time Frame: Up to 60 days post last dose ]
    For subjects with CR or PR, duration of response(DoR) is the time from the first documented CR or PR to disease progression or death assessed per RECIST V1.1 criteria.

  3. Disease control rate (DCR) [ Time Frame: Up to 60 days post last dose ]
    Disease control rate (DCR) is the percentage of CR plus PR Plus stable disease (SD) assessed per RECIST v1.1 criteria.

  4. Time to Response (TTR) [ Time Frame: Up to 60 days post last dose ]
    For subjects with CR or PR, time to response(TTR) is the time from first dose of study drugs to the first documented CR or PR assessed per RECIST v1.1 criteria.

  5. Progression-free survival (PFS) [ Time Frame: Up to 60 days post last dose ]
    Time from randomization to first documented disease progression (radiographic) assessed by investigator per RECIST v1.1 criteria or death due to any cause.

  6. Overall survival (OS) [ Time Frame: Up to 60 days post last dose ]
    Time from randomization to death of the subject due to any cause.



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

Inclusion Criteria:

  1. Male or female subjects ≥ 18 years old;
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  3. Anticipated life expectancy of ≥ 12 weeks;
  4. Adequate bone marrow and organ function;

    Criteria for dose escalation phase only:

  5. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available (mainly focused on non-small-cell lung cancer, head and neck squamous cell carcinoma and RAS-wildtype colorectal cancer);
  6. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

    Criteria for dose expansion phase only:

  7. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
  8. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria:

  1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
  2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
  3. Received total pelvic radiotherapy;
  4. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
  5. Uncontrolled diseases;
  6. History of endotracheal or gastrointestinal stent implantation;
  7. Multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured);
  8. Women who are pregnant, have positive results in pregnancy test or are lactating;
  9. Not eligible to participate in this study at the discretion of the investigator.

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): NCT05774873


Contacts
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Contact: Emilia Tan 0512-69566088 lili.tan@innoventbio.com

Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Waratah, New South Wales, Australia, 2145
Contact: Adnan Nagrial    02 8890 5200    adnan.nagrial@health.nsw.gov.au   
Principal Investigator: Bei Yu Sun, M.D.         
Principal Investigator: Qing Wen, M.D.         
Principal Investigator: Kate Wilkinson, M.D.         
Principal Investigator: Lu Ping, M.D.         
Principal Investigator: Adnan Nagrial, M.D.         
Principal Investigator: Fang Yin Gu, M.D.         
Principal Investigator: Lisi Elizabeth Lim, M.D.         
Principal Investigator: Cheng Jian Li, M.D.         
Principal Investigator: Li Mei Sun, M.D.         
Principal Investigator: Na Yi Wang, M.D.         
Principal Investigator: Chang Yong Zhang, M.D.         
Principal Investigator: Xiang Zhi Zhuang, M.D.         
Principal Investigator: Wen Xi Huang, M.D.         
Principal Investigator: Ming Jin Yu, M.D.         
Principal Investigator: Ping Yu Sun, M.D.         
Principal Investigator: Lin Wu, M.D.         
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT05774873    
Other Study ID Numbers: CIBI334A101
First Posted: March 20, 2023    Key Record Dates
Last Update Posted: November 28, 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