Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

QL1706(7.5mg/kg) Combined with Bevacizumab

QL1706

QL1604

15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV

Feng Professor Bi

Feng Bi, Professor

This is a phase Ib/II trial to evaluate the safety, pharmacokinetics and preliminary efficacy of QL1706 or QL1604 combined with bevacizumab in patients with advanced hepatocellular carcinoma.

This is an open, multicenter phase Ib/II trial of QL1706 or QL1604 combined with bevacizumabin patients with advanced hepatocellular carcinoma to evaluate the safety, PK characteristics and preliminary efficacy. This trial is divided into three cohorts, Cohort A, Cohort B and Cohort C.

Cohort A was the dose exploration phase of the study, with 2 dose groups designed, QL1706 5mg/kg q3w + bevacizumab 7.5mg/kg q3w group and QL1706 5mg/kg q3w + bevacizumab 15mg/kg q3w group, to explore the safe dose of bevacizumab.

After approximately 20 cases are enrolled in the bevacizumab safety dose group identified in Cohort A, enrollment will be initiated in Cohort B. Cohort B will be QL1604 200 mg fixed dose q3w + bevacizumab safety dose, and random enrollment will be used for both Cohort A and Cohort B.

The decision to initiate a cohort C study will be based on the preliminary results of the efficacy analysis of cohort A and cohort B. If a Cohort C study is initiated, the Cohort C dosing regimen will be QL1706 7.5 mg/kg q3w + bevacizumab safe dose q3w.

A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma

A Phase Ib/II Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of QL1706 or QL1604 Combined With Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

The DCR assessed according to RECIST v1.1

The PFS and progression-free survival at 6 and 12 months (PFS6/12)

The Overall survival and 1-year OS rate Overall survival Overall survival

The ORR assessed according to RECIST v1.1

The DOR assessed according to RECIST v1.1

Qilu Pharmaceutical Co., Ltd.

Symptoms and General Pathology

Microsatellite Instability

Shunjiang Yu, CMO

Weijian Guo, Professor

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with QL1604 monotherapy.

QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors

A Single-arm, Multi-center, Phase Ⅱ Clinical Study to Evaluate Efficacy and Safety of QL1604 Monotherapy for the Treatment of Unresectable or Metastatic Mismatch Repair Deficient (dMMR) or Microsatellite Instability-high (MSI-H) Solid Tumors That Failed to Respond to Standard Therapy

Objective response rate (assessed by independent radiological review committee (IRRC) per RECIST Version 1.1 and iRECIST)

Objective response rate (assessed by the investigators per RECIST Version 1.1 and iRECIST)

6-month progression-free survival (PFS) rate

Progression-free survival (assessed by independent radiological review committee (IRRC) per RECIST v1.1 and iRECIS)

Progression-free survival (assessed by the investigators per RECIST v1.1 and iRECIST)

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.

Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Nab-paclitaxel

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.

The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.

A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.

A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel for Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine

Overall survival is defined as time from randomization to death due to any cause.

Objective response rate（ORR）assessed by the investigators according to RECIST 1.1.

Disease control rate（DCR）assessed by the investigators according to RECIST 1.1.

Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1.

Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1.

Area under the concentration-time curve (AUC ) following single dose administration of PD-1

Peak plasma concentration (Cmax) following single dose administration of PD-1

Steady-state trough serum concentrationof multiple Dose Administration of PD-1

Steady-state peak serum concentration of multiple Dose Administration of PD-1

The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab).

Weijian Guo, PhD

Jianping Xiong, PhD

In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.

A Phase I Study of QL1604 for Advanced Solid Tumors

A Phase I Clinical Study to Evaluate Safety、 Tolerability, and Pharmacokinetics of QL1604 for the Treatment of Advanced Solid Tumors - A Phase Ic Preliminary Efficacy Expansion Study

ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma	NCT05603039	Advanced Liver ...	QL1706 QL1604 Bevacizumab	18 Years -	Qilu Pharmaceutical Co., Ltd.
A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma	NCT05603039	Advanced Liver ...	QL1706 QL1604 Bevacizumab	18 Years -	Qilu Pharmaceutical Co., Ltd.
QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors	NCT04326829	Advanced Malign...	QL1604	18 Years - 80 Years	Qilu Pharmaceutical Co., Ltd.
A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.	NCT04435652	Advanced Gastri...	QL1604 Nab-paclitaxel Paclitaxel	18 Years - 80 Years	Qilu Pharmaceutical Co., Ltd.
A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma	NCT05603039	Advanced Liver ...	QL1706 QL1604 Bevacizumab	18 Years -	Qilu Pharmaceutical Co., Ltd.
A Phase I Study of QL1604 for Advanced Solid Tumors	NCT05801094	Advanced Solid ...	QL1604	18 Years - 75 Years	Qilu Pharmaceutical Co., Ltd.
QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors	NCT04326829	Advanced Malign...	QL1604	18 Years - 80 Years	Qilu Pharmaceutical Co., Ltd.
QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors	NCT04326829	Advanced Malign...	QL1604	18 Years - 80 Years	Qilu Pharmaceutical Co., Ltd.
A Phase I Study of QL1604 for Advanced Solid Tumors	NCT05801094	Advanced Solid ...	QL1604	18 Years - 75 Years	Qilu Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for ql1604

Every month we try and update this database with for ql1604 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 ql1604

Every month we try and update this database with for ql1604 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 ql1604 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.