IBI343 in Combination Therapy for Advanced Malignant Solid Tumors

NCT07483554 | Not Yet Recruiting Phase 2

• 1 other identifier: CIBI343A201
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CLDN18.2 Positive; Gastric/Gastroesophageal Junction Adenocarcinoma; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (13)

• 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

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Drug: IBI343,Gemcitabine, Albumin-bound Paclitaxel

Interventions

IBI343,Gemcitabine, Albumin-bound Paclitaxel DRUG

IBI343,Gemcitabine, Albumin-bound Paclitaxel intravenous infusion

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent, willing and able to comply with the protocol-specified visits and related procedures.
• At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Age ≥ 18 years, no gender restrictions.
• An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Expected survival ≥ 12 weeks.
• Adequate bone marrow and organ function.
• 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.
• Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.

You may not qualify if:

• 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.
• 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.
• 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.
• Received therapeutic or palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.
• Underwent biliary stent placement within 7 days prior to the first dose of the investigational drug.
• Planning to receive other anti-tumor treatments during the period of treatment with the investigational drug.
• 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.
• 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.
• 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.
• 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.
• Presence of pyloric obstruction and/or persistent recurrent vomiting.
• Post-procedure of stent implantation in the digestive tract or trachea.
• Symptomatic central nervous system metastasis.
• Bone metastasis with risk of paraplegia.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Shuang Han

CONTACT

+86 512 6956 6088; shuang.han@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)