Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) | Experimental | Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine. |
|
| QLS31905 + oxaliplatin + capecitabine (Part B) | Experimental | In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine. |
|
| QLS31905 + gemcitabine+cisplatin(Part B) | Experimental | In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS31905 | Drug | Administered as an intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) (Part A) | As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort. | Approximately 12 months |
| Phase 2 Recommended Dose（RP2D)(Part A) | Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels. | Approximately 12 months |
| Objective response rate (ORR)(Part B) | ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1. | Approximately 12 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, M.D | Contact | 010-881965671 | linshenpku@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
Not provided
| ID | Term |
|---|---|
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nab paclitaxel | Drug | 125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle. |
|
| Gemcitabine | Drug | 1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle. |
|
| Oxaliplatin | Drug | 85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles. |
|
| Capecitabine | Drug | 1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles. |
|
| Cisplatin | Drug | 25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles. |
|
| Approximately 12 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 12 months |
| Number of participants with laboratory value abnormalities and/or adverse events (AEs) | Number of participants with potentially clinically significant laboratory values. | Approximately 12 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 progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first). | Approximately 12 months |
| Duration Of Response (DOR) | DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first). | Approximately 12 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 12 months |
| Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax) | Cmax will be derived from the PK serum samples collected. | Approximately 12 months |
| PK of QLS31905: Time of the maximum concentration (Tmax) | Tmax will be derived from the PK serum samples collected. | Approximately 12 months |
| PK of QLS31905: Terminal elimination half-life (T1/2) | T1/2 will be derived from the PK serum samples collected. | Approximately 12 months |
| PK of QLS31905: Clearance (CL) | CL will be derived from the PK serum samples collected. | Approximately 12 months |
| PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz) | Vz will be derived from the PK serum samples collected. | Approximately 12 months |
| Number of anti-drug antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | Approximately 12 months |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |