Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

JMT101, 6 mg/kg, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). or 9 mg/kg, IV infusion once every 3 weeks.

JMT101

50 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 75 mg/m2, IV infusion once every 3 weeks.

docetaxel

75 mg/m2, IV infusion once every 2 weeks (one treatment cycle is 4 weeks). Or 100 mg/m2, IV infusion once every 3 weeks.

HB1801

Clinical Trials Information Group officer

Li Zhang, M.D.

This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.

Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer

A Randomized, Controlled, Open-label Phase II/III Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel / HB1801 in Patients With sqNSCLC

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Shanghai JMT-Bio Inc.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Irinotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

240 mg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

SG001

180mg/m\^2, IV infusion once every two weeks (one treatment cycle is 4 weeks).

160 mg, taken orally once daily for the first 21 days of each 28-day cycle.

Regorafenib (Stivarga)

This study is a phase Ⅱ, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with Irinotecan and SG001 in Patients with Metastatic Colorectal Cancer (mCRC).

A Study of JMT101 in Patients With Metastatic Colorectal Cancer

A Randomized, Controlled, Open-label Phase Ⅱ Study of The Safety, Tolerability and Efficacy of JMT101 and Irinotecan Combined With SG001 in Patients With Metastatic Colorectal Cancer (mCRC)

Duration from the date of initial treatment to the date of death due to any cause.

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

JMT101 combined with two dose levels of afatinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Once the safe and effective dose has been determined, an expansion cohort will be recruited to further evaluate the efficacy and safety of the selected dose.

JMT101 will be administered intravenously at 6 mg/kg every 2 weeks (q2w) in each 28-week cycle.

Afatinib will be administered orally at 30 mg or 40 mg per day (qd) in each 28-week cycle.

Lin Shen

Yongsheng Li

Dong Qian

Suxia Luo

Chunqing Li

This study is a multi-center, open-label, phase Ib study to evaluate the safety, tolerability and efficacy of JMT101 combined with afatinib in patients with advanced esophageal squamous cell carcinoma who have failed standard treatment.

This is a multicenter, open-label, dose-escalated phase Ib study aimed to evaluate the safety, tolerability, and efficacy of JMT101 combined with afatinib in patients with advanced esophageal squamous cell carcinoma who have failed standard treatment. This study consists of two stages: dose-escalation stage and dose expansion stage. The dose-escalation stage will be conducted to determine the maximum tolerated dose (MTD) of JMT101 combined with afatinib in patients with advanced esophageal squamous cell carcinoma based on a 3+3 design. JMT101 will be given by intravenous infusion at 6 mg/kg (q2w) of each 28-week cycle. Afatinib will be sequentially administered at 30 mg and 40 mg (qd) of each 28-week cycle. One dose cohort which is verified to be well-tolerated and safe in dose-escalation stage will be selected for dose-expansion to further explore the safety, pharmacokinetic and efficacy of the study drug.

JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy

A Multicenter, Open-label, Phase Ib Study to Evaluate the Safety and Efficacy of JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Have Failed Standard Therapy

The biomarkers include PIK3CA, PTEN, KRAS, BRAF, CDH1, EGFR status detected by immunohistochemical (IHC) and fluorescence in-situ hybridization (FISH).

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).

Measure of time from first response to disease progression or death

Percentage of patients who achieve partial response (PR) or complete response (CR) or stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST)

Measure of time from study treatment to disease progression or death

Measure of time from study treatment to patient's death or lost to follow-up

area under the plasma concentration versus time curve

anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

neutralizing anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

Peking University

Clinical Professor

Osimertinib

Osimertinib, 160 mg, Oral administration once daily (one treatment cycle is 4 weeks).

Osimertinib Mesylate Tablets

Xiugao Yang

Li Zhang

This study is a phase II, open label, multi-center study to evaluate the efficacy and safety of JMT101 combined with Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer

A Phase II, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Blood samples will be collected at specified timepoints to detect the presence of anti-drug antibodies and neutralizing antibodies against JMT101

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Calcium

Calcium, Dietary

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.

Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design.

The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.

Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)

Rong Hu

Dong Yan

Jun Qian

Huan Zhou

Wenwei Hu

Weiqi Nian

Yanhong Deng

Tianshu Liu

Weichang Chen

Jufeng Wang

This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.

Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA) and neutralizing antibodies by electrochemical luminescence(ECL).

The content of RAS(reticular activating system), EGFR(epidermal growth factor receptor), BRAF(B-Raf proto-oncogene) gene will be detected.

Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design.

The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

IV infusion Q2W for 4 weeks (28-day cycles)

Da Jiang

Mingxia Wang

Yi Hu

Lin Wu

Feng Luo

Wu Zhuang

Yiping Zhang

Qian Wang

Liyun Miao

Baohui Han

Junping Zhang

Wei Guo

Xiaorong Dong

This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer

A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer	NCT06319313	Squamous Cell N...	JMT101 docetaxel HB1801	18 Years - 75 Years	Shanghai JMT-Bio Inc.
A Study of JMT101 in Patients With Metastatic Colorectal Cancer	NCT06089330	Metastatic Colo...	JMT101 SG001 Irinotecan Regorafenib (St...	18 Years - 75 Years	Shanghai JMT-Bio Inc.
JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy	NCT05164848	Esophageal Squa...	JMT101 Afatinib	18 Years -	Peking University
Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer	NCT05132777	Locally Advance... EGFR Exon20 Ins...	JMT101 Osimertinib Mes...	18 Years -	Shanghai JMT-Bio Inc.
A Study of JMT101 in Patients With Metastatic Colorectal Cancer	NCT06089330	Metastatic Colo...	JMT101 SG001 Irinotecan Regorafenib (St...	18 Years - 75 Years	Shanghai JMT-Bio Inc.
Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor	NCT04689100	Advanced Solid ...	JMT101 JMT101	18 Years - 75 Years	Shanghai JMT-Bio Inc.
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer	NCT04448379	Locally Advance...	JMT101	18 Years - 75 Years	Shanghai JMT-Bio Inc.

Spots Global Cancer Trial Database for jmt101

Every month we try and update this database with for jmt101 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 jmt101

Every month we try and update this database with for jmt101 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 jmt101 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.