> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-of-ibi389-single-agent-and-in-0d9513e5-2a74-4833-ac0d-c571fb6f5724 > Record changed: 2026-10-13 # Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies NCT05164458 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) Lead sponsor Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) Start date 2022-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Short title** Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Official title** A Phase Ia/Ib, Open Label, Multicenter Study of the Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, Administered to Patients With Advanced Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Dates **Completion date** 2024-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **First posted** 2021-12-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Registry last updated** 2023-12-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Primary completion date** 2024-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Start date** 2022-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Lead sponsor** Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Identifiers **Registry ID** NCT05164458 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **ClinicalTrials.gov ID** NCT05164458 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Outcomes ### Primary outcomes 1. Number of subjects with AEs and SAEs Timeframe: up to 2 years after enrollment To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab \\\[Adverse events (AEs), Serious Adverse Events (SAEs) \\\] 2. Percentage of Participants with Dose-Limiting Toxicities (DLTs) Timeframe: up to 28 Days following first dose To evaluate the safety and tolerability of IBI389 alone or in combination with Sintilimab. ### Secondary outcomes 1. Pharmacokinetics: AUC Timeframe: up to 2 years after enrollment The area under the curve (AUC) of serum concentration of the drug after the administration. 2. Cmax Timeframe: up to 2 years after enrollment Maximum concentration (Cmax) of the drug after administration 3. Immunogenicity: Percentage of ADA positive subjects Timeframe: up to 2 years after enrollment Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI389. 4. Preliminary anti-tumor activity of IBI389 (Objective Response Rate) Timeframe: up to 2 years after enrollment Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Provide signed informed consent; 2. Male or female aged at 18-75 (inclusive) years; 3. Expected survival ≥12 weeks; 4. ECOG PS score 0 or 1; 5. Provide archival or fresh tissues for CLDN18.2 expression analysis; 6. Adequate laboratory parameters; 7. 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 ### Exclusion criteria 1. Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study. 2. Any investigational drugs received within 4 weeks prior to the first study treatment. 3. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy. 4. Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug. 5. Medication requiring long-term systemic hormones or any other immunosuppression therapy. 6. 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. 7. 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. 8. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease. 9. History of autoimmune disease , present active autoimmune disease or inflammatory diseases 10. Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function. 11. Positive human immunodeficiency virus (HIV) test. 12. Active hepatitis B or C, or tuberculosis. 13. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 14. History of gastrointestinal perforation and/or fistula at 6 months prior to study inclusion. 15. Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage. 16. Known history of hypersensitivity to any components of the IBI389 or Sintilimab. 17. Uncontrolled complications of disease. 18. Other acute or chronic illness, mental illness, or abnormal laboratory test values that may increase the risk of study participation or administration of study drugs, or interfere with the interpretation of study results. 19. Pregnant or nursing females. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Sites - West China Hospital of Sichuan UniversityChengdu, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## References - PubMed 41540424 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41540424/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05164458) ## Related records ### Drugs (2) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) - [Sintilimab](https://trialight.com/data/asset/sintilimab-e2618eaf-967e-401c-aed4-7546875a6d3e.md) ### Lead sponsors (1) - [Innovent Biologics (Suzhou) Co. Ltd.](https://trialight.com/data/company/innovent-biologics-suzhou-co-ltd-cd395d6d-f2bc-41a8-9a5c-6d6d1871bceb.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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