Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies

NCT05164458 | Unknown Phase 1

• 1 other identifier: CIBI389A101
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of IBI389 as a single agent, and in combination with sintilimab, and (or) chemotherapy in patients with advanced or metastatic solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of subjects with AEs and SAEs

  To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

  up to 2 years after enrollment

• Percentage of Participants with Dose-Limiting Toxicities (DLTs)

  To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab.

  up to 28 Days following first dose

Secondary Outcomes (4)

• Pharmacokinetics: AUC

  up to 2 years after enrollment

• Cmax

  up to 2 years after enrollment

• Immunogenicity: Percentage of ADA positive subjects

  up to 2 years after enrollment

• Preliminary anti-tumor activity of IBI389 (Objective Response Rate)

  up to 2 years after enrollment

Study Arms (2)

IBI389

EXPERIMENTAL

A dose escalation stage of IBI 389 monotherapy.

Drug: IBI 389 Injection

IBI 389 + sintilimab

EXPERIMENTAL

A dose escalation stage of IBI 389 in combination with sintilimab.

Drug: IBI 308 injection; Drug: IBI 389 Injection

Interventions

IBI 308 injection DRUG

IBI308 IV 200mg Q3W Day1

IBI 389 + sintilimab

IBI 389 Injection DRUG

IBI 389 IV Q2\~Q3W Day 1

IBI 389 + sintilimab; IBI389

Eligibility Criteria

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

You may qualify if:

• Provide signed informed consent;
• Male or female aged at 18-75 (inclusive) years;
• Expected survival ≥12 weeks;
• ECOG PS score 0 or 1;
• Provide archival or fresh tissues for CLDN18.2 expression analysis;
• Adequate laboratory parameters;
• Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
• Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
• Ib: pancreatic carcinoma, gastric adenocarcinoma, advanced or metastatic solid tumors

You may not qualify if:

• Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
• Any investigational drugs received within 4 weeks prior to the first study treatment.
• Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
• Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
• Medication requiring long-term systemic hormones or any other immunosuppression therapy.
• Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
• There was unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAE v5.0 induced by previous antitumor therapy (24 weeks before the first dose of study), and there were unrecovered immune-related adverse events (irAE) associated with immunotherapy.
• Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
• History of autoimmune disease , present active autoimmune disease or inflammatory diseases
• Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function.
• Positive human immunodeficiency virus (HIV) test.
• Active hepatitis B or C, or tuberculosis.
• History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.
• Known history of hypersensitivity to any components of the IBI389 or Sintilimab.

Sponsors & Collaborators

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

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (1)

• Li X, Dai R, Xu Q, Guo Z, Hu C, Sun Y, Niu Z, Hao J, Zhang M, Dai G, Hua D, Pan Y, Wang X, Wei S, Chen X, Wu Q, Zhang Y, Zhou H, Ying J, Zheng L, Bi F. Safety and preliminary efficacy results of IBI389, an anti-Claudin18.2xCD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: a phase 1 dose escalation and expansion study. BMC Med. 2026 Jan 16. doi: 10.1186/s12916-025-04597-8. Online ahead of print.

  PMID: 41540424 DERIVED

MeSH Terms

Interventions

sintilimab

Central Study Contacts

xiaoqin ruan

CONTACT

18610683729; xiaoqin.ruan@innoventbio.com

Study Design

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

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 20, 2021
• Study Start: March 22, 2022
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)