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A Study of Dose Escalation of IBI321 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04911894
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: IBI321 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib, Open-Label, Multi-Center, Study of the Safety, Tolerability and Primary Efficacy of IBI321 in Patients With Advanced Solid Tumors
Actual Study Start Date : July 16, 2021
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : July 30, 2024

Arm Intervention/treatment
Experimental: Phase Ia Dose-Escalation Stage: IBI321 Drug: IBI321
Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.




Primary Outcome Measures :
  1. Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Day 1 of Cycle 1 to Day 28 ]
  2. Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 [ Time Frame: From Day 1 to up to 2 years ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. [ Time Frame: From Baseline until disease progression (up to 2 years) ]
  2. Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. [ Time Frame: From Baseline until disease progression (up to 2 years) ]
  3. Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. [ Time Frame: From Baseline until disease progression (up to 2 years) ]
  4. Overall Survival (OS) [ Time Frame: From Baseline until disease progression (up to 2 years) ]
  5. Area Under the Concentration-Time Curve (AUC) of IBI321 [ Time Frame: From Day 1 up to 2 years ]
  6. Maximum Serum Concentration (Cmax) of IBI321 [ Time Frame: From Day 1 up to 2 years ]
  7. Minimum Serum Concentration (Cmin) of IBI321 [ Time Frame: From Day 1 up to 2 years ]
  8. Clearance (CL) of IBI321 [ Time Frame: From Day 1 up to 2 years ]
  9. Percentage of Participants with Anti-Drug Antibodies (ADAs) and Neutralizing Antibody (Nab) to IBI321 [ Time Frame: From Day 1 up to 2 years ]


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. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  2. Patients with advanced solid tumors who had failed standard treatment.
  3. Male or female subjects ≥18 years and ≤75 years.
  4. At least one measurable lesion per RECIST version 1.1
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
  6. Life expectancy of ≥ 12 weeks.
  7. Adequate hematologic and end organ function

Exclusion Criteria:

  1. Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
  2. Failure to recover from adverse events from the most recent anti-tumor
  3. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  4. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
  5. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
  6. Pregnancy, lactation, breastfeeding.

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): NCT04911894


Contacts
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Contact: xiaoqin ruan 0512-69566088 xiaoqin.ruan@innoventbio.com
Contact: Jieer Ying 13858195803 jieerying@aliyun.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiangdong Cheng, Doctor    0571-86819906    chengxd516@126.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT04911894    
Other Study ID Numbers: CIBI321A102
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021

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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