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A Phase I Study of IBI325 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.
 
ClinicalTrials.gov Identifier: NCT05119998
Recruitment Status : Not yet recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: IBI325 + sintilima Drug: IBI325 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, in Patients With Advanced Solid Tumor
Estimated Study Start Date : February 14, 2022
Estimated Primary Completion Date : February 14, 2023
Estimated Study Completion Date : October 14, 2023

Arm Intervention/treatment
Experimental: IBI325 and sintilimab combination does-escalation Drug: IBI325 + sintilima
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation

Experimental: IBI325 monotherapy does-escalation Drug: IBI325
IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation




Primary Outcome Measures :
  1. Number of patients with DLT [ Time Frame: 28 days post first dose ]
    Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose

  2. Number of patients with treatment related AEs [ Time Frame: Up to 90 days post last dose ]
    Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose


Secondary Outcome Measures :
  1. Number of patients with response [ Time Frame: Every 6 weeks until progressive disease or up to 24 months after treatment ]
    Number of patients with response per RECIST 1.1

  2. The area under the curve (AUC) [ Time Frame: Up to 90 days post last dose ]
  3. Maximum concentration (Cmax) [ Time Frame: Up to 90 days post last dose ]
  4. Time at which maximum concentration (Tmax) [ Time Frame: Up to 90 days post last dose ]
  5. The half-life (t1/2) [ Time Frame: Up to 90 days post last dose ]
  6. Positive rate of ADA and Nab [ Time Frame: Up to 90 days post last dose ]


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Histologically confirmed, locally advanced unresectable or metastatic tumors.
  2. At least one evaluable or measurable lesion per RECIST 1.1
  3. Male or female subject at least 18 years old and no more than 75 years old.
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
  5. Must have adequate organ function
  6. Be able to provide archived or fresh tumor tissues-

Exclusion Criteria:

  1. Previous exposure to any anti-CD73 monoclonal antibody
  2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
  3. Unstable central nervous system netastases
  4. Known active autoimmune disease or inflammatory disease
  5. Known active infectious disease
  6. Other uncontrolled systematic disease that may increase the risk of participating the study-

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): NCT05119998


Contacts
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Contact: Yu Jinming 0531-67626073 sdyujinming@126.com

Locations
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China, Shandong
Shandong Province Cancer Hospital
Jinan, Shandong, China, 250117
Contact: Li Huijuan    0531-67626073    ywb234@126.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT05119998    
Other Study ID Numbers: CIBI325A101
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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