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Completed

NCT Number: NCT05119998

A Phase I Study of IBI325 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

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Key information

Conditions

Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shandong Province Cancer Hospital

Jinan, Shandong, 250117, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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-

Exclusion criteria

  • 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-

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Number of patients with DLT

    Time frame: 28 days post first dose

    Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose

  2. 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

Secondary outcomes

  1. Number of patients with response

    Time frame: Every 6 weeks until progressive disease or up to 24 months after treatment

    Number of patients with response per RECIST 1.1

  2. The area under the curve (AUC)

    Time frame: Up to 90 days post last dose

  3. Maximum concentration (Cmax)

    Time frame: Up to 90 days post last dose

  4. Time at which maximum concentration (Tmax)

    Time frame: Up to 90 days post last dose

  5. The half-life (t1/2)

    Time frame: Up to 90 days post last dose

  6. Positive rate of ADA and Nab

    Time frame: Up to 90 days post last dose

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2021
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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