IBI343 in Combination Therapy for Advanced Malignant Solid Tumors

A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of IBI343 in Combination Therapy for Patients With Advanced Malignant Solid Tumors.

A Phase II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of IBI343 in combination therapy for patients with advanced malignant solid tumors.To evaluate the efficacy and safety of IBI343 in combination therapy for patients with advanced malignant solid tumors.Enrollment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma positive for CLDN18.2, and subjects with pancreatic ductal adenocarcinoma positive for CLDN18.2.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma; Gastric/Gastroesophageal Junction Adenocarcinoma; CLDN18.2 Positive
• Intervention / Treatment: Drug: IBI343,Gemcitabine, Albumin-bound Paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 389
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shuang Han; Phone Number: +86 512 6956 6088; Email: shuang.han@innoventbio.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Tingbo Liang; Phone Number: 0571-87236685; Email: liangtingbo_trial@163.com
      • Contact: Xueli Bai; Phone Number: 0571-87236685; Email: liangtingbo_trial@163.com
      • Principal Investigator: Xueli Bai, PhD
      • Principal Investigator: Tingbo Liang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Signed written informed consent, willing and able to comply with the protocol-specified visits and related procedures.
2. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
3. Age ≥ 18 years, no gender restrictions.
4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
5. Expected survival ≥ 12 weeks.
6. Adequate bone marrow and organ function.
7. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the end of treatment.
8. Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.

Exclusion criteria:

1. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.
2. Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug.
3. Received the last anti-tumor treatment within 4 weeks or 5 half-lives of the anti-tumor therapy (whichever is shorter) before the first dose of the investigational drug.
4. Received therapeutic or palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.
5. Underwent biliary stent placement within 7 days prior to the first dose of the investigational drug.
6. Planning to receive other anti-tumor treatments during the period of treatment with the investigational drug.
7. Received any live vaccine within 4 weeks prior to the first dose of the investigational drug or planning to receive any live vaccine during the study.
8. Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has unhealed wounds, ulcers, or fractures; or plans to undergo major surgery during the study.
9. Has not recovered from toxicity caused by previous treatment to grade 0 or 1 according to NCI CTCAE v5.0 prior to the first dose of the investigational drug.
10. History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the investigational drug that was not cured by surgical treatment.
11. Presence of pyloric obstruction and/or persistent recurrent vomiting.
12. Post-procedure of stent implantation in the digestive tract or trachea.
13. Symptomatic central nervous system metastasis.
14. Bone metastasis with risk of paraplegia.
15. Interstitial lung disease requiring steroid treatment, or history of interstitial lung disease, non-infectious pneumonia, severe impairment of pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having these diseases during the screening period.
16. Presence of uncontrolled disease.
17. History of other primary malignant tumors.
18. Known history of immunodeficiency.
19. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
20. Previous treatment with topoisomerase inhibitor-based antibody-drug conjugates.
21. For subjects receiving drug treatment, a history of allergy to the corresponding drug or formulation.
22. For subjects receiving drug treatment, contraindications for the corresponding drug.
23. For subjects receiving drug treatment, a history of permanent discontinuation of the corresponding drug due to related adverse reactions.
24. Pregnant or lactating female subjects.
25. Other conditions deemed unsuitable for participation in this study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm	Drug: IBI343,Gemcitabine, Albumin-bound Paclitaxel; IBI343,Gemcitabine, Albumin-bound Paclitaxel intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) evaluated according to RECIST v1.1		Up to 24 months
Incidence of Adverse Events (AE)		Up to 24 months
Incidence of treatment-emergent adverse Events (TEAE)		Up to 24 months
Incidence of adverse events of Special Interest (AESI)		Up to 24 months
Incidence of serious adverse events (SAE)		Up to 24 months
Number of participants with abnormal laboratory tests results		Up to 24 months
Number of subjects with clinically significant changes in physical examination results	Clinically significant abnormal physical examination findings reported by the investigator.	Up to 24 months
Number of subjects with clinically significant changes in vital signs	Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Response (DoR) evaluated according to RECIST v1.1	Up to 24 months
Disease Control Rate (DCR) evaluated according to RECIST v1.1	Up to 24 months
Time to Response (TTR) evaluated according to RECIST v1.1	Up to 24 months
Progression-Free Survival (PFS) evaluated according to RECIST v1.1	Up to 24 months
Overall Survival (OS)	Time to death
Area under the concentration-time curve for subjects receiving IBI343 treatment	Up to 24 months
Peak concentration for subjects receiving IBI343 treatment	Up to 24 months
Time to peak concentration for subjects receiving IBI343 treatment	Up to 24 months
Trough concentration for subjects receiving IBI343 treatment	Up to 24 months
Clearance for subjects receiving IBI343 treatment.	Up to 24 months
Apparent volume of distribution for subjects receiving IBI343 treatment.	Up to 24 months
Half-life for subjects receiving IBI343 treatment.	Up to 24 months
Positive rate of anti-drug antibodies	Up to 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Albumins; Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine
• Other Study ID Numbers: CIBI343A201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No