BridgeMD
New treatment option for CLDN18.2 Positive
Official title IBI343 in Combination Therapy for Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT07483554
What this study is testing
What is IBI343,Gemcitabine, Albumin-bound Paclitaxel?
IBI343,Gemcitabine, Albumin-bound Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cldn18.2 positive.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join if
- Currently participating in another treatment clinical study, except for observational (non-treatment) clinical studies or those in the survival...
- 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...
- 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...
- 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.
See the full eligibility 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 people of childbearing potential or male people 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.
- Currently participating in another treatment clinical study, except for observational (non-treatment) clinical studies or those in the survival follow-up phase of an treatment 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...
- 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 people receiving drug treatment, a history of allergy to the corresponding drug or formulation.
- For people receiving drug treatment, contraindications for the corresponding drug.
- For people receiving drug treatment, a history of permanent discontinuation of the corresponding drug due to related adverse reactions.
- Pregnant or lactating female people.
- Other conditions deemed unsuitable for participation in this study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.