Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Patients will receive HX008 3mg/kg by intravenous (IV) infusion on Day 1, every 3 weeks (Q3W), till progressed disease or withdrawal.

HX008

Jun Guo, MD

HX008 is a humanized monoclonal antibody targeting PD-1 on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the efficacy and safety of HX008 in patients with locally advanced or metastatic melanoma who have failed the standard treatments will be evaluated.

A Study of HX008 for the Treatment of Patients With Malignant Melanoma

A Single-armed Open-labeled Phase II Study of HX008 (a Humanized Monoclonal Antibody Targeting PD-1) for the Treatment of Patients With Locally Advanced or Metastatic Melanoma Who Have Failed the Standard Treatments.

Percentage of subjects achieving complete response (CR) and partial response (PR).

Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.

Duration of Response (DOR) is defined as the time from the first evidence of response (PR or CR) to the first evidence of PD or the date of death for any reason.

Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.

Taizhou Hanzhong biomedical co. LTD

MRG003 will be administrated via intravenous infusion at 1.5, 2.0 mg/kg (MTD=2.5 mg/kg) once on Day 1 of every 3 weeks (21-day cycle).

HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day cycle).

MRG003+HX008

Program Director

Ruihua Xu, M.D.

Yingrui Shi, M.D.

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors.

This study consists of two parts: Phase I and Phase II. The objective of this study is to assess the safety and tolerability of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors; and to explore the maximum tolerated dose (MTD) and to determine the recommended phase II dose (RP2D) of combination therapy; and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.

A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors

An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MRG003 in Combination With HX008 in Patients With EGFR-positive Advanced Solid Tumors

MTD is the highest dose with the proportion of DLT less than 1/3

The dose level of MRG003 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment.

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

OS is defined as the duration from the start of treatment to death of any cause.

The proportion of patients with positive ADA results.

Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

Adverse events that are difficult to deal with in clinical drug research

Plot of drug concentration changing with time after drug administration

Shanghai Miracogen Inc.

MRG002 will be administrated via intravenous infusion at 1.8，,2.2, or 2.6 mg/kg , (if appropriate) once on Day 1 of every 3 weeks (21-day cycle), up to 24 months.

HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day- cycle), up to 24 months.

MRG002+HX008

Suxia Luo, Doctor

Zhenyang Liu, Doctor

Yuping Sun, Doctor

Jin Li, Doctor

Ying yuan, Doctor

Jin Li, MD

The objective of this study is to assess the safety and tolerability of MRG002 in combination with HX008 in patients with HER2-expressed advanced malignant solid tumors; and to , explore the maximum tolerated dose (MTD), and to determine the recommended phase II dose (RP2D) of combination therapy; , and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.

A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.

An Open-label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of MRG002 in Combination With HX008 in Patients With HER2-expressed Advanced Malignant Solid Tumors.

DLT is defined as any of the treatment emergent adverse events (TEAE) as specified in the protocol that bear a definite, probable, or possible causal relationship to study drug administration within 28 days after the first dose.

The dose level of MRG002 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.

ORR is defined as the proportion of subjects with CR and PR according to RECIST v1.1.

TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.

Plot of drug concentration changing with time after drug administration.

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Lenvatinib

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W.

Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD).

200 mg administered as IV infusion on Day 1 of each 21-day cycle.

15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.

Administered orally once a day during each 21-day cycle

Jianqiang Cai

Lianxin Liu

Lianhai Zhang

Che Xu

Yuxian Bai

Jufeng Wang

Xiaohai Mao

Wenxiang Dai

Wei Wu

Jing Lv

Bo Li

Tianqiang Song

Jianfei Tu

This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody HX008 plus bevacizumab or lenvatinib in the first-line treatment of patients with unresectable hepatocellular carcinoma.

Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

An Open-label, Multicenter, Phase II Clinical Study of HX008 in Combination With Bevacizumab or Lenvatinib in Patients With Advanced Hepatocellular Carcinoma (HCC)

ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.

OS was defined as the time from the date of beginning of HX008 administration until date of death from any cause.

TTP is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigators.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

Nong Yang

Shanzhi Gu

Xiaorong Dong

HX008 is a humanized monoclonal antibody targeting PD-1 on the T cell surface, restores T cell activity, thus enhancing immune response, and has the potential to treat various types of tumors. In this study, the tolerance and safety of HX008 in patients with advanced solid tumors will be evaluated.

A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors

A Phase Ib Study of Tolerance and Safety of a Recombinant Anti-PD-1 Monoclonal Antibody HX008 in Patients With Advanced Solid Tumors

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Irinotecan

Topoisomerase I Inhibitors

Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.

Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.

160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.

Irinotecan Hydrochloride Injection

Administered as IV infusion on Day 1 of each 21-day cycle.

Placebo

Jing Huang, MD

Yifu He

Yueyin Pan

Zhendong Chen

Guangyu An

Lin Zhao

Bangwei Cao

Baoshan Cao

Jun Liang

Weiqing Chen

Rongbo Lin

Chuan Jin

Jianjun Xiao

Shubin Wang

Chunxia Du

Zhihui Liu

Sheng Ye

Shengmian Li

Na Li

Aimin Zang

Suxia Luo

Qingxia Fan

Xinshuai Wang

Shundong Cang

Xianling Liu

Shan Zeng

Xianli Yin

Zhenping Wen

Yang Ling

Lingjun Zhu

Yang Yang

Cailian Wang

Lei Yang

Zhixiang Zhuang

Yuan Yuan

Jiandong Tong

Xiaojun Xiang

Yiye Wan

Ying Cheng

Wei Li

Yunpeng Liu

Jingdong Zhang

Ping Chen

Weibo Wang

Bo Liu

Ping Sun

Hongxia Wang

Zan Shen

Lu Wen

Enxiao Li

Jin Lu

Diansheng Zhong

Xinjun Liang

Wenran Wang

Yong Tang

Qing Bi

Yi Zheng

Liqin Lu

Hongming Pan

Haijun Zhong

Zhiming Huang

This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.

HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of HX008 for the Treatment of Patients With Malignant Melanoma	NCT04749485	Melanoma	HX008	18 Years - 75 Years	Taizhou Hanzhong biomedical co. LTD
A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors	NCT05688605	Advanced Solid ...	MRG003+HX008	18 Years - 75 Years	Shanghai Miracogen Inc.
A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.	NCT05338957	Advanced Malign...	MRG002+HX008	18 Years - 75 Years	Shanghai Miracogen Inc.
A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.	NCT05338957	Advanced Malign...	MRG002+HX008	18 Years - 75 Years	Shanghai Miracogen Inc.
Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)	NCT04741165	Hepatocellular ...	HX008 Bevacizumab Lenvatinib	18 Years - 75 Years	Taizhou Hanzhong biomedical co. LTD
A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors	NCT04825392	Advanced Solid ...	HX008	18 Years -	Taizhou Hanzhong biomedical co. LTD
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer	NCT04486651	Stomach Cancer	Irinotecan Hydr... HX008 Placebo	18 Years - 75 Years	Taizhou Hanzhong biomedical co. LTD
A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer	NCT05652894	Metastatic Colo...	HX008 Investigator's ...	18 Years -	Taizhou Hanzhong biomedical co. LTD
A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors	NCT04825392	Advanced Solid ...	HX008	18 Years -	Taizhou Hanzhong biomedical co. LTD
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer	NCT04738630	Bladder Cancer	HX008	18 Years -	Taizhou Hanzhong biomedical co. LTD

Spots Global Cancer Trial Database for hx008

Every month we try and update this database with for hx008 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 hx008

Every month we try and update this database with for hx008 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 hx008 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.