A Phase I Study of IBI325 in Patients With Advanced Solid Tumor

February 17, 2022 updated by: Jinming Yu, Shandong Cancer Hospital and Institute

A Phase I, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, Combined With Sintilimab in Patients With Advanced Solid Tumor

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 combined with Sintilimab in patients with advanced solid tumors

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong province cancer hospital
        • Contact:
        • Principal Investigator:
          • Sun Yuping, M.D.
        • Principal Investigator:
          • Xing Ligang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion

  1. Histologically confirmed, locally advanced unresectable or metastatic tumors.
  2. At least one 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

1. Any anti-tumor treatment with 4 weeks, except 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI325 and Sintilimab combination does-escalation
Drug: IBI325+Sintilimab
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination until progressive disease, intolerability, or other reasons leading to treatment discontinuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with DLT
Time Frame: 42 days post first dose
Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose
42 days post first dose
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
Up to 90 days post last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with response
Time Frame: Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first
Number of patients with response per RECIST 1.1
Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 23, 2022

Primary Completion (Anticipated)

March 23, 2023

Study Completion (Anticipated)

November 23, 2023

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI325Y001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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