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

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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: IBI325 + sintilimab; Drug: IBI325

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong province cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with treatment related AEs	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
Number of patients with DLT	Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose	28 days post first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of ADA and Nab		Up to 90 days post last dose
Number of patients with response	Number of patients with response per RECIST 1.1	Every 6 weeks until progressive disease or up to 24 months after treatment
The area under the curve (AUC)		Up to 90 days post last dose
Maximum concentration (Cmax)		Up to 90 days post last dose
Time at which maximum concentration (Tmax)		Up to 90 days post last dose
The half-life (t1/2)		Up to 90 days post last dose

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI325A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No