IBI343 in Combination Therapy for Advanced Malignant Solid Tumors (NCT07483554) | Clinical Trial Compass
Not Yet RecruitingPhase 2
IBI343 in Combination Therapy for Advanced Malignant Solid Tumors
China389 participantsStarted 2026-03-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Objective Response Rate (ORR) evaluated according to RECIST v1.1
Timeframe: Up to 24 months
2
Incidence of Adverse Events (AE)
Timeframe: Up to 24 months
3
Incidence of treatment-emergent adverse Events (TEAE)
Timeframe: Up to 24 months
4
Incidence of adverse events of Special Interest (AESI)
Timeframe: Up to 24 months
5
Incidence of serious adverse events (SAE)
Timeframe: Up to 24 months
6
Number of participants with abnormal laboratory tests results
Timeframe: Up to 24 months
7
Number of subjects with clinically significant changes in physical examination results
Timeframe: Up to 24 months
8
Number of subjects with clinically significant changes in vital signs
✕. 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.