Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Fluzoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants will be administered QL1101 7.5 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Fluzoparib will be administered orally twice daily continuously throughout each 21-day cycle. On Day 1 of each cycle, fluzoparib will be administered upon completion of QL1101 infusion. The starting dose of fluzoparib will be based on the participant's Baseline actual body weight or platelet count.

Maintenance QL1101 7.5 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. QL1101 will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of QL1101 received with chemotherapy.

QL1101

Yongpeng Wang

This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line platinum-based chemotherapy with QL1101. Eligible participants who achieve complete response (CR) or partial response (PR) following treatment with platinum-based chemotherapy in addition to QL1101 will be enrolled in the study and will receive maintenance treatment with fluzoparib (for up to 2 years) combined with QL1101 (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first.

A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib Combined With QL1101 for Maintenance Treatment in Patients With Advanced Epithelial Ovarian Cancer Following Response After First-line Platinum-containing Chemotherapy

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time.

Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first. The impact of this study's maintenance regimen on patient follow-up was determined by assessing the time from enrollment to second progression (PFS2), or the purpose of the PFS2 analysis was to demonstrate whether maintenance treatment could reduce the benefit provided by follow-up.

The evaluation of the efficacy of first-line platinum-based chemotherapy and maintenance therapy by assessing the time to first follow-up or death, in addition to the similar assessment role as for PFS, allows evaluation of whether the regimen has an impact on follow-up and, if follow-up is delayed, on PFS2 and OS.

To evaluate the effects of this trial protocol on health-related quality of life (HRQoL) in patients with high-risk advanced epithelial ovarian cancer as assessed by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Ovary (FACT-O).The TOI ranges from 0 to 100, with higher scores associated with higher HRQoL.

Principal Investigator

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antibodies

Bevacizumab

Angiogenesis Inhibitors

Immunomodulating Agents

Immunoglobulins

Antineoplastic Agents, Immunological

Growth Inhibitors

Participants receive bevacizumab 7.5mg/kg and tripleitriumab 240mg in day 1 intravenously every 3week until disease progression or unacceptable toxicity

Tripleitriumab

Hanguang Hu, M.D.

Ying Yuan, M.D.

This is a single-arm,open-label, prospective, single-center Study of QL1101 and JS001 in patients with pMMR/MSS refractory metastatic colorectal cancer.

QL1101 is a biosimilar of bevacizumab (Avastin) produced and provided by Qilu Pharmaceutical Co., Ltd., which has been marketed in China.It's a humanized monoclonal IgG1 antibody prepared by recombinant DNA technology. By binding to human vascular endothelial growth factor (VEGF), it inhibits the binding of VEGF to its receptor, blocks the signal transduction pathway of angiogenesis, and inhibits tumor cell growth. Be produced and provided by Shanghai Junshi Bioscience Co., Ltd. ,JS001(Tripleitriumab) is the first China-developed humanized monoclonal antibody against programmed death 1 (PD-1) approved for marketing in China.

Antiangiogenic drugs combined with PD-1 monoclonal antibodies may reverse the insensitivity of pMMR/MSS refractory colorectal cancer to PD-1 inhibitors.

The primary objective of this study is to investigate the safety and efficacy of the subjects who given the combination therapy.

QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer

QL1101A,a Biosimilar of Bevacizumab,in Combination With JS001,a Anti-pd-1 Antibody in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer: a Single-arm,Open-Label, Prospective, Single-center Study

Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. PFS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%.

Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. OS will be tested at the one-sided 10% level.

Best objective response will be evaluated via RECIST 1.1 and iRECIST criteria. Will be compared using Fisher's exact tests with a one-sided type I error rate of 2.5%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.

Disease control is defined as maintaining Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) as the tumor assessment result during the defined time window. DCR (percentage) is defined as number of patients with success of disease control divided by total number of patients in the analysis population multiplied by 100, excluding patients who refuse treatment before the initiation of any treatment. CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir, SD: Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD

The distribution of DOR by treatment group will be estimated using the method of Kaplan-Meier. Six and 12 month durable response (i.e. maintaining CR or PR without progressive disease \[PD\]) rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir

Qilu Pharmaceutical Co., Ltd.

Shanghai Junshi Bioscience Co., Ltd.

Second Affiliated Hospital, School of Medicine, Zhejiang University

QL1101, intravenous infusion 90 min (±5min), D1 (Day 1, single dose)

Avastin®, intravenous infusion 90 min (±5min), D1 (Day 1, single dose)

3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day

Avastin®

Xiaojiao Li

The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL1101 with EU-Avastin® in healthy male volunteers.

Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 groups.

This is a phase I,single center, randomized, double-blind and parallel group clinical trial .

The primary objective is to assess the pharmacokinetic similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers.

The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers.

Subjects would receive a single 100mg（4ml） of QL1101or EU-Avastin® injection.

A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers

A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers

To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single intravenous infusion in healthy volunteers

To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single

To evaluate pharmacokinetic similarity between QL1101 and Avastin®

Safety, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.after a single intravenous infusion in healthy volunteers;

Immunogenicity will be assessed by the incidence of ADA and Nab.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Endothelial Growth Factors

Mitogens

Tubulin Modulators

Antimitotic Agents

QL1101 + paclitaxel/carboplatin:subjects are given 15 mg/kg QL1101 on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles (at least 4 cycles).

Avastin® + paclitaxel/carboplatin:subjects are given 15 mg/kg Avastin® on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles (at least 4 cycles).

targeted vascular endothelial growth factor (VEGF) monoclonal antibodies

175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6.

AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6.

The objective of this study is to assess the similarity between QL1101 and Avastin® respectively combined with chemotherapy in terms of efficacy and safety in patients with non-squamous non-small cell lung cancer. The study intends to include first-line patients with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small cell lung cancer.

The study is a randomized, double-blind, positive drug-controlled, multi-center Phase III study. It is planned to enroll 512 treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). Subjects are randomized into the QL1101 combined with paclitaxel/carboplatin or Avastin® combined with paclitaxel/carboplatin treatment group by a ratio of 1:1, and stratified by age (≥65 years, \<65 years), sex (male, female) and EGFR subtype (sensitive mutation type, wild type).

Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer

A Multi-center, Randomized, Double-blind, Parallel, Two-group Phase III Clinical Study of the Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer

The actual endpoint is best response seen during the study

DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death

OS is defined as the time from randomization and grouping to patient death due to various causes. For patients who are lost to follow-up, the date when they were contacted for the last time will be used as the cut off time.

PFS is defined as the time from randomization and grouping to PD or death.

Assessment following therapy with either QL1101 or avastin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy	NCT05585281	Ovarian Cancer	Fluzoparib QL1101	18 Years - 70 Years	Liaoning Tumor Hospital & Institute
QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer	NCT04527068	Refractory Meta... pMMR MSS	Bevacizumab Tripleitriumab	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer	NCT04527068	Refractory Meta... pMMR MSS	Bevacizumab Tripleitriumab	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers	NCT06232902	Tumor	QL1101 Avastin®	18 Years - 50 Years	Qilu Pharmaceutical Co., Ltd.
A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy	NCT05585281	Ovarian Cancer	Fluzoparib QL1101	18 Years - 70 Years	Liaoning Tumor Hospital & Institute
Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer	NCT03169335	Non-squamous No...	QL1101 Avastin® Paclitaxel Carboplatin	18 Years - 75 Years	Qilu Pharmaceutical Co., Ltd.
QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer	NCT04527068	Refractory Meta... pMMR MSS	Bevacizumab Tripleitriumab	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University

Spots Global Cancer Trial Database for ql1101

Every month we try and update this database with for ql1101 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 ql1101

Every month we try and update this database with for ql1101 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 ql1101 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.