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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119998
• Other study ID #: CIBI325A101
• Status: Completed
• Phase: Phase 1
• Start date: February 8, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: October 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 8, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	Shandong Province Cancer Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	The area under the curve (AUC)		Up to 90 days post last dose
Secondary	Maximum concentration (Cmax)		Up to 90 days post last dose
Secondary	Time at which maximum concentration (Tmax)		Up to 90 days post last dose
Secondary	The half-life (t1/2)		Up to 90 days post last dose
Secondary	Positive rate of ADA and Nab		Up to 90 days post last dose