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This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS31905 + oxaliplatin + capecitabine | Experimental | Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine. |
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| QL1706 + oxaliplatin + capecitabine | Experimental | Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine. |
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| QLS31905 + oxaliplatin + capecitabine + QL1706 | Experimental | Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706. |
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| QLS31905 + gemcitabine+cisplatin | Experimental | Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin. |
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| QL1706 + gemcitabine+cisplatin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS31905 | Drug | Administered as an intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by Adverse Events (AEs) | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin. |
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| QLS31905 + gemcitabine+cisplatin+ QL1706 | Experimental | Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706. |
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| QLS31905 + standard chemotherapy | Experimental | Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines. |
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| QL1706 + standard chemotherapy | Experimental | Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines. |
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| QLS31905 + standard chemotherapy + QL1706 | Experimental | Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706. |
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| Oxaliplatin | Drug | 130 mg/m2, intravenous infusion, D1, up to 8 cycles. |
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| Capecitabine | Drug | 1000 mg/m2, oral, bid, D1-D14 |
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| Gemcitabine | Drug | 1000 mg/m2 administered as IV infusion on D1/D8 of each cycle. |
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| Cisplatin | Drug | 25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles. |
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| QL1706 | Drug | 5 mg/kg, intravenous infusion,D1 |
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| Chemotherapy drug | Drug | Standard chemotherapy recommended by guidelines. |
|
| Approximately 24 months |
| Safety assessed by incidence of serious adverse events (SAE) | Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event. | Approximately 24 months |
| Number of participants with laboratory value abnormalities | Number of participants with potentially clinically significant laboratory values. | Approximately 24 months |
| Duration of Response (DOR) | DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first). | Approximately 24 months |
| Progression Free Survival(PFS) | PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first). | Approximately 24 months |
| Overall Survival (OS) | OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause. | Approximately 24 months |
| Maximum concentration (Cmax) | Cmax will be derived from the PK serum samples collected. | Approximately 24 months |
| Time of the maximum concentration (Tmax) | Tmax will be derived from the PK serum samples collected. | Approximately 24 months |
| Terminal elimination half-life (T1/2) | T1/2 will be derived from the PK serum samples collected. | Approximately 24 months |
| Clearance (CL) | CL will be derived from the PK serum samples collected. | Approximately 24 months |
| Apparent volume of distribution during the terminal phase (Vz) | Vz will be derived from the PK serum samples collected. | Approximately 24 months |
| Number of anti-drug antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | Approximately 24 months |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |