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CLDN18.2 PositivePhase 2NCT07483554

IBI343 in Combination Therapy for Advanced Malignant Solid Tumors

A Phase 2 study testing IBI343,Gemcitabine, Albumin-bound Paclitaxel in people with CLDN18.2 Positive and Gastric/Gastroesophageal Junction Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IBI343,Gemcitabine, Albumin-bound Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
389 participants
Where
1 siteChina
Study dates
20 Apr 2026to 31 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Presence of uncontrolled disease.
  • History of other primary malignant tumors.
  • Known history of immunodeficiency.
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Previous treatment with topoisomerase inhibitor-based antibody-drug conjugates.
  • For subjects receiving drug treatment, a history of allergy to the corresponding drug or formulation.
  • For subjects receiving drug treatment, contraindications for the corresponding drug.
  • For subjects receiving drug treatment, a history of permanent discontinuation of the corresponding drug due to related adverse reactions.
  • Pregnant or lactating female subjects.
  • Other conditions deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shuang Han contact

+86 512 6956 6088

shuang.han@innoventbio.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Tingbo Liang, 0571-87236685, liangtingbo_trial@163.com

    Xueli Bai, 0571-87236685, liangtingbo_trial@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
IBI343,Gemcitabine, Albumin-bound Paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI343,Gemcitabine, Albumin-bound PaclitaxelDrug

    IBI343,Gemcitabine, Albumin-bound Paclitaxel intravenous infusion

Study groups in NCT07483554
Study groupRoleWhat they receive
Experimental ArmExperimentalNot described
Receives: Drug: IBI343,Gemcitabine, Albumin-bound Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) evaluated according to RECIST v1.1

    Measured: Up to 24 months

  2. Incidence of Adverse Events (AE)

    Measured: Up to 24 months

  3. Incidence of treatment-emergent adverse Events (TEAE)

    Measured: Up to 24 months

  4. Incidence of adverse events of Special Interest (AESI)

    Measured: Up to 24 months

  5. Incidence of serious adverse events (SAE)

    Measured: Up to 24 months

  6. Number of participants with abnormal laboratory tests results

    Measured: Up to 24 months

  7. Number of subjects with clinically significant changes in physical examination results

    Clinically significant abnormal physical examination findings reported by the investigator.

    Measured: Up to 24 months

  8. Number of subjects with clinically significant changes in vital signs

    Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

    Measured: Up to 24 months

Secondary outcomes (13)

  1. Duration of Response (DoR) evaluated according to RECIST v1.1

    Measured: Up to 24 months

  2. Disease Control Rate (DCR) evaluated according to RECIST v1.1

    Measured: Up to 24 months

  3. Time to Response (TTR) evaluated according to RECIST v1.1

    Measured: Up to 24 months

  4. Progression-Free Survival (PFS) evaluated according to RECIST v1.1

    Measured: Up to 24 months

  5. Overall Survival (OS)

    Measured: Time to death

  6. Area under the concentration-time curve for subjects receiving IBI343 treatment

    Measured: Up to 24 months

  7. Peak concentration for subjects receiving IBI343 treatment

    Measured: Up to 24 months

  8. Time to peak concentration for subjects receiving IBI343 treatment

    Measured: Up to 24 months

  9. Trough concentration for subjects receiving IBI343 treatment

    Measured: Up to 24 months

  10. Clearance for subjects receiving IBI343 treatment.

    Measured: Up to 24 months

  11. Apparent volume of distribution for subjects receiving IBI343 treatment.

    Measured: Up to 24 months

  12. Half-life for subjects receiving IBI343 treatment.

    Measured: Up to 24 months

  13. Positive rate of anti-drug antibodies

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start20 Apr 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
389 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483554
Sponsor's protocol ID
CIBI343A201
Status last verified
Jun 2026
First submitted
16 Mar 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI343,Gemcitabine, Albumin-bound Paclitaxel in people with CLDN18.2 Positive and Gastric/Gastroesophageal Junction Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shuang Han (+86 512 6956 6088, shuang.han@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) evaluated according to RECIST v1.1 (time frame: Up to 24 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07483554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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