Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Oxaliplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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.

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.

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.

QLS31905

125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.

Nab paclitaxel

1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.

85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.

25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

Lin Shen, M.D

This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors

A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors

As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.

Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.

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.

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.

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.

Number of participants with potentially clinically significant laboratory values.

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).

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).

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.

Cmax will be derived from the PK serum samples collected.

Tmax will be derived from the PK serum samples collected.

T1/2 will be derived from the PK serum samples collected.

CL will be derived from the PK serum samples collected.

Vz will be derived from the PK serum samples collected.

Immunogenicity will be measured by the number of participants that are ADA positive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors	NCT06041035	Solid Tumor	QLS31905 Nab paclitaxel Gemcitabine Oxaliplatin Capecitabine Cisplatin	18 Years -	Qilu Pharmaceutical Co., Ltd.
A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors	NCT06041035	Solid Tumor	QLS31905 Nab paclitaxel Gemcitabine Oxaliplatin Capecitabine Cisplatin	18 Years -	Qilu Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for qls31905

Every month we try and update this database with for qls31905 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for qls31905

Every month we try and update this database with for qls31905 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for qls31905 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.