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A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

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: NCT05043298
Recruitment Status : Not yet recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
This is an open label Phase Ia trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: IBI 360 Injection Phase 1

Detailed Description:
Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy in advanced or metastatic Solid Tumors.

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Study Type : Interventional
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
Estimated Study Start Date : October 7, 2021
Estimated Primary Completion Date : March 25, 2024
Estimated Study Completion Date : June 18, 2024

Arm Intervention/treatment
Experimental: IBI360 Drug: IBI 360 Injection
IBI 360 dose level of escalation IV Q3W Day 1

Primary Outcome Measures :
  1. Safety and tolerance [ Time Frame: up to 90 days following last dose ]
    Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)

  2. Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 21 days following last dose level ]
    A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data

Secondary Outcome Measures :
  1. Tumor response [ Time Frame: Subjects were randomized 6 months and 1 year later ]
    Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).

  2. Area under plasma concentration vs time curve(AUC) [ Time Frame: Up to 48 weeks following first dose ]
  3. Peak plasma concentration(Cmax) [ Time Frame: Up to 48 weeks following first dose ]
  4. Terminal Half Life(T1/2) [ Time Frame: Up to 48 weeks following first dose ]
  5. Immunogenicity [ Time Frame: up to 90 days following last dose ]
    Incidence of anti-drug antibodies (ADA) will be measured

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

Inclusion Criteria:

  1. Provide signed informed consent;
  2. Male or female aged at 18-75 (inclusive) years;
  3. Expected survival ≥12 weeks;
  4. ECOG PS score 0 or 1;
  5. Provide archival or fresh tissues for CLDN18.2 expression analysis;
  6. Adequate laboratory parameters;
  7. Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:

Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.

Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors

Exclusion Criteria:

  1. The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
  2. The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
  3. Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
  4. The subjects with history of hypersensitivity to the study drug;
  5. The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
  6. The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
  7. The subjects with pyloric obstruction;
  8. The subjects with active or poorly controlled serious infections

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): NCT05043298

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Contact: feng ye 05922137572

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China, Jiangsu
Innovent Biologics (suzhou) Co. , Ltd.
Suzhou, Jiangsu, China, 215000
Contact: yunxia feng    13553093695   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd. Identifier: NCT05043298    
Other Study ID Numbers: CIBI360A101
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: August 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
Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.:
Advanced Solid Tumor
Additional relevant MeSH terms:
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