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

NCT05119998 | Completed Phase 1

• 1 other identifier: CIBI325A101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Number of patients with response

  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

Study Arms (2)

IBI325 and sintilimab combination does-escalation

EXPERIMENTAL

Drug: IBI325 + sintilimab

IBI325 monotherapy does-escalation

EXPERIMENTAL

Drug: IBI325

Interventions

IBI325 + sintilimab DRUG

IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation

IBI325 and sintilimab combination does-escalation

IBI325 DRUG

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

IBI325 monotherapy does-escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed, locally advanced unresectable or metastatic tumors.
• At least one evaluable or measurable lesion per RECIST 1.1
• Male or female subject at least 18 years old and no more than 75 years old.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
• Must have adequate organ function
• Be able to provide archived or fresh tumor tissues-

You may not qualify if:

• Previous exposure to any anti-CD73 monoclonal antibody
• Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
• Unstable central nervous system netastases
• Known active autoimmune disease or inflammatory disease
• Known active infectious disease
• Other uncontrolled systematic disease that may increase the risk of participating the study-

Sponsors & Collaborators

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

Study Sites (1)

Shandong Province Cancer Hospital

Jinan, Shandong, 250117, China

Location

MeSH Terms

Interventions

sintilimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: February 8, 2022
• Primary Completion: July 27, 2023
• Study Completion: August 8, 2023
• Last Updated: August 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)