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Study of IBI343 for Advanced Solid Tumors

This study is testing a new drug called IBI343, alone or with chemotherapy drugs like FOLFIRINOX/mFOLFIRINOX or mFOLFOX, for people with locally advanced unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) solid tumors. The main goals are to understand the safety of IBI343, find the right dose, and see how well it's tolerated. Researchers will also look at how the body handles IBI343 and its effectiveness. You may be eligible if you are 18 or older and have at least one measurable tumor. This is a "first-in-human" study, meaning it's one of the first times IBI343 is being tested in people. The study is open-label, meaning you and your doctors will know which treatment you are receiving.

Study design
This is a Phase Ia/Ib, multicenter, open-label, first-in-human study. It plans to enroll 470 participants and is being conducted in countries like China, Australia, and the US.
What's involved
IBI343 will be given intravenously (IV) every 21 days, or every 14 days. Chemotherapy will be given IV every 14 days. You will have visits and procedures as specified by the study protocol.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to 90 days after your last treatment. The recommended dose will be determined within 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05458219

A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Innovent Biologics (Suzhou) Co. Ltd.
~470 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:IBI343FOLFIRINOX/mFOLFIRINOXmFOLFOX

At a glance

Recruiting sites
38 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events(AEs), treatment emergent adverse event (TEAEs)，serious adverse events (SAEs)
Measured over Up to 90 days after the last administration
+16 more outcomes measured

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

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Where it's being run

39 sites across 20 states
Shandong4
Zhejiang4
Texas3
Anhui3
Shanghai Municipality3
New South Wales2
Queensland2
Beijing Municipality2

Who to contact

Suhua Dong
[email protected]
0512-69566088
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hepatic function: TBIL ≤ 1.5 × ULN (TBIL ≤ 3 × ULN is allowed for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN for participants without liver metastasis and ≤ 5 × ULN for participants with liver metastasis; Albumin ≥ 28 g/L;
Renal function: estimated creatinine clearance ≥ 30mL/min (using Appendix 5. Calculation of Estimated Creatinine Clearance and Body Surface ).
Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (participants receiving anticoagulant therapy with coagulation function within the above range are allowed). 7. Female participants of childbearing potential or male participants whose partners are female of childbearing potential are required to use effective contraceptive measures throughout the treatment period and for 6 months after the final treatment period.
CLDN18.2-positive: defined as ≥ 1% of tumor cells with membranous staining of any intensity in tumor tissue by immunohistochemistry, when tested previously, at the study site, or at the central laboratory.
High expression of CLDN18. 2: Claudin18.2 immunohistochemical membrane staining intensity ≥ 2 + in ≥ 75% of tumor cells.
Moderate to high expression of CLDN18.2: Claudin18.2 immunohistochemical membrane staining intensity ≥ 2 + in ≥ 40% of tumor cells.
Specified expression of CLDN18.2: Claudin18.2 immunohistochemical membrane staining intensity 1+/2+/3+ in ≥50% of tumor cells.

What this trial measures

  • Adverse events(AEs), treatment emergent adverse event (TEAEs)，serious adverse events (SAEs)Up to 90 days after the last administration

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.

  • Dose-limiting Toxicity (DLT)21 days after the first dose of IBI343

    DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

  • To determine RP2D of IBI343.Up to 2 years

    To determine RP2D of IBI343.

  • ORR assessed by the investigator based on RECIST version 1.1.Up to 2 years

    ORR assessed by the investigator based on RECIST version 1.1.ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR)

  • Number of subjects with clinically significant changes in physical examination resultsUp to 2 years

    A complete physical examination will include: general appearance, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and pharynx), lymph nodes, thyroid, musculoskeletal (including spine and extremities), genital/anal, and neurological assessments, if indicated. Clinically significant abnormal findings at screening will be recorded as medical history or AE based on the investigator's analysis and judgment.

  • Number of participants with abnormal vital signsThrough study completion, up to 2 years

    Collection of vital signs will include temperature in ℃, measurement tool is physiological parameter

  • Objective response rate (ORR)ORR is defined as the proportion of participants with a completeresponse (CR) or partial response (PR)

    Through study completion, up to 2 years

  • Number of participants with abnormal laboratory tests resultsThrough study completion, up to 2 years

    Blood routine：RBC, HGB, HCT, WBC, PLT, LYM, ANC

  • Number of participants with abnormal vital signsThrough study completion, up to 2 years

    Collection of vital signs will include pulse in beats per minute. measurement tool is physiological parameter

  • Number of participants with abnormal vital signsThrough study completion, up to 2 years

    Collection of vital signs will include respiratory rate in times/min. measurement tool is physiological parameter

  • Number of participants with abnormal vital signsThrough study completion, up to 2 years

    Collection of vital signs will include blood pressure in kPa. measurement tool is physiological parameter

  • Number of participants with abnormal laboratory tests resultsThrough study completion, up to 2 years

    Blood biochemistry: TBIL, DBIL, ALT, AST, γ-GGT, ALP, ALB, TP, LDH, Urea or BUN, Cr, Na, K, Cl, Mg, Ca, P, Amylase, Lipase and FBG

  • Number of participants with abnormal laboratory tests resultsThrough study completion, up to 2 years

    Urinalysis: PH, Specific Gravity, UWBC, UPRO, URBC, UGLU, UBLD

  • Number of participants with abnormal laboratory tests resultsThrough study completion, up to 2 years

    Coagulation function: APTT, PT, INR, Fbg, D-dimer

  • Number of participants with abnormal laboratory tests resultsThrough study completion, up to 2 years

    Viral serology test: HBsAg, HBsAb, HBcAb, HBeAg, HBeAb, HBV DNA, HCV antibody, HCV RNA, HIV antibody, Treponema pallidum-specific antibody

  • Number of participants with abnormal laboratory tests resultsThrough study completion, up to 2 years

    Myocardial injury markers: CK, CK-MB, Troponin I or T, BNP or NT-proBNP

  • Number of participants with abnormal laboratory tests resultsThrough study completion, up to 2 years

    Fecal analysis: occult blood (OB)