CLDN18.2 Positive, Gastric/Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
Conditions
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.
Interventions
DRUGIBI343,Gemcitabine, Albumin-bound Paclitaxel
IBI343,Gemcitabine, Albumin-bound Paclitaxel intravenous infusion
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent, willing and able to comply with the protocol-specified visits and related procedures. 2. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 3. Age ≥ 18 years, no gender restrictions. 4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Expected survival ≥ 12 weeks. 6. Adequate bone marrow and organ function. 7. 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. 8. Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.
Exclusion criteria
1. 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. 2. 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. 3. 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. 4. Received therapeutic or palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug. 5. Underwent biliary stent placement within 7 days prior to the first dose of the investigational drug. 6. Planning to receive other anti-tumor treatments during the period of treatment with the investigational drug. 7. 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. 8. 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. 9. 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. 10. 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. 11. Presence of pyloric obstruction and/or persistent recurrent vomiting. 12. Post-procedure of stent implantation in the digestive tract or trachea. 13. Symptomatic central nervous system metastasis. 14. Bone metastasis with risk of paraplegia. 15. 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. 16. Presence of uncontrolled disease. 17. History of other primary malignant tumors. 18. Known history of immunodeficiency. 19. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 20. Previous treatment with topoisomerase inhibitor-based antibody-drug conjugates. 21. For subjects receiving drug treatment, a history of allergy to the corresponding drug or formulation. 22. For subjects receiving drug treatment, contraindications for the corresponding drug. 23. For subjects receiving drug treatment, a history of permanent discontinuation of the corresponding drug due to related adverse reactions. 24. Pregnant or lactating female subjects. 25. Other conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 24 months | Clinically significant abnormal physical examination findings reported by the investigator. |
| Number of subjects with clinically significant changes in vital signs | Up to 24 months | Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Area under the concentration-time curve for subjects receiving IBI343 treatment | Up to 24 months |
| Peak concentration for subjects receiving IBI343 treatment | Up to 24 months |
| Time to peak concentration for subjects receiving IBI343 treatment | Up to 24 months |
| Trough concentration for subjects receiving IBI343 treatment | Up to 24 months |
| Clearance for subjects receiving IBI343 treatment. | Up to 24 months |
| Apparent volume of distribution for subjects receiving IBI343 treatment. | Up to 24 months |
| Half-life for subjects receiving IBI343 treatment. | Up to 24 months |
| Positive rate of anti-drug antibodies | Up to 24 months |
Countries
China
Contacts
CONTACTShuang Han
Outcome results
None listed