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The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine [AG]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS31905 + nab-paclitaxel + gemcitabine (AG) | Experimental |
| |
| Placebo + nab-paclitaxel + gemcitabine (AG) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS31905 | Drug | QLS31905 will be administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Suryival(OS) | OS is defined as the time from randomization to deathdue to any cause. | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first). | Up to 48 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, M.D | Contact | 010-88196561 | linshenpku@163.com | |
| Jihui Hao, M.D | Contact | 022-23340123-3070 | haojihui@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| Nab-paclitaxel. | Drug | Nab-paclitaxel will be administered as an IV infusion. |
|
| Gemcitabine | Drug | Gemcitabine will be administered as an IV infusion. |
|
| Placebo for QLS31905 | Drug | Placebo will be administered as an IV infusion. |
|
| Nab-paclitaxel. | Drug | Nab-paclitaxel will be administered as an IV infusion |
|
| Gemcitabine | Drug | Gemcitabine will be administered as an IV infusion. |
|
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. Time Frame: Up to 48 months |
| Up to 48 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). | Up to 48 months |
| 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. | Up to 48 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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