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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05119998
Collaborator
(none)
48
1
2
19.9
2.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Feb 14, 2023
Anticipated Study Completion Date :
Oct 14, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with DLT [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 [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 Outcome Measures

  1. Number of patients with response [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) [Up to 90 days post last dose]

  3. Maximum concentration (Cmax) [Up to 90 days post last dose]

  4. Time at which maximum concentration (Tmax) [Up to 90 days post last dose]

  5. The half-life (t1/2) [Up to 90 days post last dose]

  6. Positive rate of ADA and Nab [Up to 90 days post last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shandong Province Cancer Hospital Jinan Shandong China 250117

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT05119998
Other Study ID Numbers:
  • CIBI325A101
First Posted:
Nov 15, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022