Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of Simmitecan Monotherapy and Combination in Patients With Advanced Solid Tumors
NCT ID: NCT02870036
Last Updated: 2017-07-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE1
Total Enrollment
243 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-10-31
Study Completion Date
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study evaluates the safety, tolerability, preliminary efficacy and pharmacokinetics of Simmitecan in patients with advanced solid tumors and Simmitecan, 5-fluorouracil and Leucovorin Calcium,thalidomide in patients with advanced solid tumor or advanced/metastatic colorectal cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor
NCT01832298
Advanced Solid Tumor
COMPLETED
PHASE1
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
NCT07265921
Advanced Solid Cancer
RECRUITING
PHASE1
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
NCT07050459
Locally Advanced Solid Tumors
RECRUITING
PHASE1
First in Human Study of SIM0610 in Solid Tumors
NCT07348211
Advanced Solid Tumours
Non-Small Cell Lung Cancer
Colorectal Cancer
+2 more
RECRUITING
PHASE1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors
NCT05781360
Locally Advanced Unresectable or Metastatic Solid Tumor
TERMINATED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Advanced Solid Tumor
Advanced/Metastatic Colorectal Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pharmacokinetic data investigation of Simmitecan
To further determine the pharmacokinetic (PK) characteristics of Simmitecan monotherapy in patients with advanced solid tumors
Group Type
EXPERIMENTAL
Simmitecan
Intervention Type
DRUG
Dose escalation study of Simmitecan combined therapy
To determine the maximum tolerated dose (MTD) of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced solid tumor
Group Type
EXPERIMENTAL
Simmitecan
Intervention Type
DRUG
5-fluorouracil and Leucovorin Calcium
Intervention Type
DRUG
Dose extension study of Simmitecan monotherapy
To preliminarily evaluate the anti-tumor activity of Simmitecan monotherapy in patients with advanced solid tumors, and to determine the recommended phase II dose (RP2D)
Group Type
EXPERIMENTAL
Simmitecan
Intervention Type
DRUG
Dose extension study of Simmitecan combined Thalidomide
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced/metastatic colorectal cancer (CRC), and to determine RP2D
Group Type
EXPERIMENTAL
Simmitecan
Intervention Type
DRUG
Thalidomide
Intervention Type
DRUG
Dose escalation&extension Simmitecan combined Thalidomide
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with gastrointestinal tumors, and to determine RP2D and MTD
Group Type
EXPERIMENTAL
Simmitecan
Intervention Type
DRUG
Thalidomide
Intervention Type
DRUG
Dose extension study of Simmitecan combined therapy
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with specific tumors
Group Type
EXPERIMENTAL
Simmitecan
Intervention Type
DRUG
5-fluorouracil and Leucovorin Calcium
Intervention Type
DRUG
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Simmitecan
Intervention Type
DRUG
5-fluorouracil and Leucovorin Calcium
Intervention Type
DRUG
Thalidomide
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Patients who have fully understood the study, and are willing to sign the informed consent (ICF);
2. Patients with advanced solid tumor confirmed by histopathology and/or cytology were enrolled in Parts 1 and 2 of the study; Four groups of patients with advanced solid tumor confirmed by histopathology and/or cytology were enrolled in Part 3 of the study: Group 1 consisted of patients with rectal carcinoma, Group 2 consisted of patients with gastric carcinoma and esophageal carcinoma, Group 3 consisted of patients with biliary duct carcinoma and pancreatic carcinoma, and Group 4 consisted of patients with gastro-entero-pancreatic neuroendocrine carcinoma. Patients with advanced or metastatic CRC confirmed by histopathology and/or cytology were enrolled in Part 4 of the study; In Part 5 of the study, patients with advanced gastrointestinal tumor (including biliary tumor \[gallbladder carcinoma, intra- or extra-hepatic biliary carcinoma\], pancreatic carcinoma, hepatocellular carcinoma, esophageal carcinoma, gastric carcinoma, colorectal carcinoma, gastrointestinal stromal carcinoma, and gastro-entero-pancreatic neuroendocrine carcinoma) confirmed by histopathology were enrolled; In Part 6 of the study, patients with advanced gastrointestinal tumor (tentatively determined as biliary tumor, hepatocellular carcinoma, pancreatic carcinoma, and colorectal carcinoma); At least 5 unstained slices of tumor tissues must be obtained at baseline from patients participating in Parts 5 and 6 of the study: Primary lesion samples at the initial diagnosis or archived recently were acceptable. They were used to detect protein expression level of SOD1 and other related molecules to and tumor immunity related indicators.
Note: patients being enrolled in part 2 of the study should be those with advanced solid tumor who are suitable for therapeutic regimen of Simmitecan combined with 5 FU/LV as judged by the investigator;
3. Patients who had failed standard treatments for advanced cancer, or are intolerant to the current standard treatments, or no suitable standard treatments available for advanced cancer;
4. Patients who have at least one measurable lesion (according to RECIST, version 1.1); note: the lesions previously treated with radiotherapy cannot be regarded as the target lesion, unless the lesion showed clear progression after radiotherapy;
5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
6. Age≥ 18 years and ≤ 70 years, male or female is allowed;
7. Patients with life expectancy of 12 weeks or more;
8. Patients with appropriate organ function as documented by:
1. absolute neutrophil count ≥ 1.5 × 109/L;
2. hemoglobin ≥ 9 g/dL (without RBC transfusion within 14 days);
3. platelet count ≥ 100 × 109/L.
4. serum total bilirubin ≤1.5 times of upper limit of normal (ULN) (for the patients with Gilbert syndrome, total bilirubin is allowed to be ≤ 3 × ULN and direct bilirubin is allowed to be 1.5 × ULN);
5. aspertate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN, or AST and ALT ≤ 5 × ULN for patients with liver metastasis;
6. creatinine clearance ≥ 50 mL/min (calculated by MDRD equation, see appendix 7);
7. international normalized ratio (INR) ≤1.5 × ULN, or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (INR only for patients who were not given anticoagulant therapy).
9. Patients with negative hepatitis b surface antigen; for patients with positive hepatitis b surface antigen, quantitative result of hepatitis b virus (HBV) DNA should be lower than 1000 cps/mL;
10. Toxicity events caused by previous treatments, surgery or radiotherapy have recovered to CTCAE grade 0 or 1 (except for alopecia);
11. Female patients are eligible for the study if the following conditions are met:
1. Patients have no fertility (i.e., physiological infertility), including postmenopausal period (complete menolipsis for more than 1 year) or documented irreversible sterilization operation including hysterectomy, bilateral ovariectomy, or bilateral salpingectomy (instead of tubal ligation);
2. For patients of childbearing potential, the results of serum pregnancy test screening should be negative (within 7 days before the first dose of investigational drug), and breastfeeding is not allowed before the start of the study and throughout the study. Moreover, the patients should agree to take effective contraception measures during the study and within 90 days after the last dose, and should always conduct strict birth control in accordance with the label of drug/appliance and the investigator's instructions. Effective contraception measure is defined as:
* The sexual partner with removed deferens is the only sexual partner of female patient;
* Use of any intrauterine device with documented failure rate less than 1% per year;
* Double contraception, such as spermicide plus male condom, female condom, diaphragm, cervical cap or intrauterine contraceptive device.
12. Male patients should have undergone vasectomy, or agree to take effective contraception measures during the study and within 90 days after the last dose;
13. Patients are able to follow the study procedures, restrictions and requirements at the investigator's discretion.
2. Patients with advanced solid tumor confirmed by histopathology and/or cytology were enrolled in Parts 1 and 2 of the study; Four groups of patients with advanced solid tumor confirmed by histopathology and/or cytology were enrolled in Part 3 of the study: Group 1 consisted of patients with rectal carcinoma, Group 2 consisted of patients with gastric carcinoma and esophageal carcinoma, Group 3 consisted of patients with biliary duct carcinoma and pancreatic carcinoma, and Group 4 consisted of patients with gastro-entero-pancreatic neuroendocrine carcinoma. Patients with advanced or metastatic CRC confirmed by histopathology and/or cytology were enrolled in Part 4 of the study; In Part 5 of the study, patients with advanced gastrointestinal tumor (including biliary tumor \[gallbladder carcinoma, intra- or extra-hepatic biliary carcinoma\], pancreatic carcinoma, hepatocellular carcinoma, esophageal carcinoma, gastric carcinoma, colorectal carcinoma, gastrointestinal stromal carcinoma, and gastro-entero-pancreatic neuroendocrine carcinoma) confirmed by histopathology were enrolled; In Part 6 of the study, patients with advanced gastrointestinal tumor (tentatively determined as biliary tumor, hepatocellular carcinoma, pancreatic carcinoma, and colorectal carcinoma); At least 5 unstained slices of tumor tissues must be obtained at baseline from patients participating in Parts 5 and 6 of the study: Primary lesion samples at the initial diagnosis or archived recently were acceptable. They were used to detect protein expression level of SOD1 and other related molecules to and tumor immunity related indicators.
Note: patients being enrolled in part 2 of the study should be those with advanced solid tumor who are suitable for therapeutic regimen of Simmitecan combined with 5 FU/LV as judged by the investigator;
3. Patients who had failed standard treatments for advanced cancer, or are intolerant to the current standard treatments, or no suitable standard treatments available for advanced cancer;
4. Patients who have at least one measurable lesion (according to RECIST, version 1.1); note: the lesions previously treated with radiotherapy cannot be regarded as the target lesion, unless the lesion showed clear progression after radiotherapy;
5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
6. Age≥ 18 years and ≤ 70 years, male or female is allowed;
7. Patients with life expectancy of 12 weeks or more;
8. Patients with appropriate organ function as documented by:
1. absolute neutrophil count ≥ 1.5 × 109/L;
2. hemoglobin ≥ 9 g/dL (without RBC transfusion within 14 days);
3. platelet count ≥ 100 × 109/L.
4. serum total bilirubin ≤1.5 times of upper limit of normal (ULN) (for the patients with Gilbert syndrome, total bilirubin is allowed to be ≤ 3 × ULN and direct bilirubin is allowed to be 1.5 × ULN);
5. aspertate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN, or AST and ALT ≤ 5 × ULN for patients with liver metastasis;
6. creatinine clearance ≥ 50 mL/min (calculated by MDRD equation, see appendix 7);
7. international normalized ratio (INR) ≤1.5 × ULN, or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (INR only for patients who were not given anticoagulant therapy).
9. Patients with negative hepatitis b surface antigen; for patients with positive hepatitis b surface antigen, quantitative result of hepatitis b virus (HBV) DNA should be lower than 1000 cps/mL;
10. Toxicity events caused by previous treatments, surgery or radiotherapy have recovered to CTCAE grade 0 or 1 (except for alopecia);
11. Female patients are eligible for the study if the following conditions are met:
1. Patients have no fertility (i.e., physiological infertility), including postmenopausal period (complete menolipsis for more than 1 year) or documented irreversible sterilization operation including hysterectomy, bilateral ovariectomy, or bilateral salpingectomy (instead of tubal ligation);
2. For patients of childbearing potential, the results of serum pregnancy test screening should be negative (within 7 days before the first dose of investigational drug), and breastfeeding is not allowed before the start of the study and throughout the study. Moreover, the patients should agree to take effective contraception measures during the study and within 90 days after the last dose, and should always conduct strict birth control in accordance with the label of drug/appliance and the investigator's instructions. Effective contraception measure is defined as:
* The sexual partner with removed deferens is the only sexual partner of female patient;
* Use of any intrauterine device with documented failure rate less than 1% per year;
* Double contraception, such as spermicide plus male condom, female condom, diaphragm, cervical cap or intrauterine contraceptive device.
12. Male patients should have undergone vasectomy, or agree to take effective contraception measures during the study and within 90 days after the last dose;
13. Patients are able to follow the study procedures, restrictions and requirements at the investigator's discretion.
Exclusion Criteria
1. Patients are still within 5 half-life of previous anticancer chemotherapy, biological agents or other investigational drugs (if 5 half-life exceeds 28 days, calculated as 28 days) at the time of screening;
2. Patients received systemic radiotherapy (including whole brain radiotherapy) within 28 days before enrollment, or received small area radiotherapy (stereotactic radiotherapy of central nervous system (CNS)) within 7 days before enrollment, or have not yet recovered from the previous radiotherapy;
3. Patients have not yet recovered from the toxic effects (except alopecia) caused by previous anti-tumor treatments (\> CTCAE grade 1);
4. Patients underwent major surgery or have not yet been fully recovered from pervious surgery (major surgery is defined as grade 3 or 4 surgery specified in "Management Measures for Clinical Application of Medical Technology" implemented on May 1st, 2009).
5. Patients had CNS metastasis or cancer-related epilepsy requiring clinical intervention; however, patients with CNS metastasis who received treatments, or the asymptomatic patient can be enrolled;
6. Patients with a history of allergy to 5-FU or LV;
7. Patients with active HBV or HCV infection;
8. Patients diagnosed as human immunodeficiency virus (HIV) infection, or are not willing to have HIV test;
9. Patients with clinically significant active infection;
10. Patients with previous or concurrent other malignant tumors (except effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other effectively controlled tumors in the past 5 years even without treatments);
11. Patients with impaired cardiac function or clinically significant heart diseases, including grade 2 or higher congestive heart failure per New York Heart Association (NYHA) classification, arrhythmia, conduction abnormalities requiring treatment, cardiomyopathy, or uncontrolled hypertension;
12. Patients with serious kidney damage requiring kidney dialysis;
13. Patients with serious liver damage, grade B or C end-stage liver diseases per Child-Pugh classification (see appendix 8);
14. Any other diseases or conditions with clinical significance that may affect the protocol compliance or patient's signature of ICF at the investigator's discretion (such as uncontrolled diabetes, etc.);
15. Patients with disease of digestive tract such as duodenal ulcer, ulcerative colitis, intestinal obstruction or other conditions that may cause alimentary tract hemorrhage or perforation as judged by the investigator, or have past medical history of gastric-intestinal perforation or intestinal fistula;;
16. Patient's physical condition cause the risk of investigational drug use, or render the toxicity or AE difficult to explain at the investigator's discretion.
17. Patients who received Irinotecan therapy within 3 months prior to enrollment.
18. Patients with arteriovenous thromboembolic events within the past 6 months, including myocardial infarction, cerebral stroke, deep vein thrombosis, or pulmonary embolism, etc.
19. Patients who were sensitive to Thalidomide (in Parts 5 and 6).
20. Peripheral neuropathy CTCAE ≥ Grade 2 (in Parts 5 and 6).
2. Patients received systemic radiotherapy (including whole brain radiotherapy) within 28 days before enrollment, or received small area radiotherapy (stereotactic radiotherapy of central nervous system (CNS)) within 7 days before enrollment, or have not yet recovered from the previous radiotherapy;
3. Patients have not yet recovered from the toxic effects (except alopecia) caused by previous anti-tumor treatments (\> CTCAE grade 1);
4. Patients underwent major surgery or have not yet been fully recovered from pervious surgery (major surgery is defined as grade 3 or 4 surgery specified in "Management Measures for Clinical Application of Medical Technology" implemented on May 1st, 2009).
5. Patients had CNS metastasis or cancer-related epilepsy requiring clinical intervention; however, patients with CNS metastasis who received treatments, or the asymptomatic patient can be enrolled;
6. Patients with a history of allergy to 5-FU or LV;
7. Patients with active HBV or HCV infection;
8. Patients diagnosed as human immunodeficiency virus (HIV) infection, or are not willing to have HIV test;
9. Patients with clinically significant active infection;
10. Patients with previous or concurrent other malignant tumors (except effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other effectively controlled tumors in the past 5 years even without treatments);
11. Patients with impaired cardiac function or clinically significant heart diseases, including grade 2 or higher congestive heart failure per New York Heart Association (NYHA) classification, arrhythmia, conduction abnormalities requiring treatment, cardiomyopathy, or uncontrolled hypertension;
12. Patients with serious kidney damage requiring kidney dialysis;
13. Patients with serious liver damage, grade B or C end-stage liver diseases per Child-Pugh classification (see appendix 8);
14. Any other diseases or conditions with clinical significance that may affect the protocol compliance or patient's signature of ICF at the investigator's discretion (such as uncontrolled diabetes, etc.);
15. Patients with disease of digestive tract such as duodenal ulcer, ulcerative colitis, intestinal obstruction or other conditions that may cause alimentary tract hemorrhage or perforation as judged by the investigator, or have past medical history of gastric-intestinal perforation or intestinal fistula;;
16. Patient's physical condition cause the risk of investigational drug use, or render the toxicity or AE difficult to explain at the investigator's discretion.
17. Patients who received Irinotecan therapy within 3 months prior to enrollment.
18. Patients with arteriovenous thromboembolic events within the past 6 months, including myocardial infarction, cerebral stroke, deep vein thrombosis, or pulmonary embolism, etc.
19. Patients who were sensitive to Thalidomide (in Parts 5 and 6).
20. Peripheral neuropathy CTCAE ≥ Grade 2 (in Parts 5 and 6).
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haihe Biopharma Co., Ltd.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijin, Beijing Municipality, China
Site Status
RECRUITING
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Site Status
NOT_YET_RECRUITING
Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Site Status
NOT_YET_RECRUITING
Hunan Cancer Hospital
Changsha, Hunan, China
Site Status
NOT_YET_RECRUITING
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Site Status
NOT_YET_RECRUITING
The first hospital of China Medical University
Shenyang, Liaoning, China
Site Status
NOT_YET_RECRUITING
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Site Status
NOT_YET_RECRUITING
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Site Status
NOT_YET_RECRUITING
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Site Status
NOT_YET_RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
China
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Feng Ji Feng, M.D
Role: primary
13901581264
References
Explore related publications, articles, or registry entries linked to this study.
Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, Andre T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouche O. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Federation Francophone de Cancerologie Digestive, Federation Nationale des Centres de Lutte Contre le Cancer, and Groupe Cooperateur Multidisciplinaire en Oncologie) study. J Clin Oncol. 2014 Nov 1;32(31):3520-6. doi: 10.1200/JCO.2013.54.1011. Epub 2014 Oct 6.
Reference Type
BACKGROUND
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GV-LP-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Study of Simmitinib Plus SG001 in Advanced Solid Tumors
NCT06132217
NOT_YET_RECRUITING
PHASE1/PHASE2
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
NCT04671849
UNKNOWN
PHASE1
Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma
NCT04156698
ACTIVE_NOT_RECRUITING
PHASE2
PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in Recurrent or Metastatic Anaplastic Thyroid Cancer
NCT05659186
RECRUITING
PHASE2
Myeloprotection With Trilaciclib in Pan-cancer Population
NCT06297811
NOT_YET_RECRUITING
PHASE2
Sintilimab Combined With Metformin in First-Line Chemotherapy Refractory Advanced NSCLC Patients
NCT03874000
UNKNOWN
PHASE2
A Phase Ⅱ Trials of Sintilimab as Consolidation Therapy After Radical Concurrent Chemoradiotherapy in Locally Advanced Unresectable ESCC
NCT04514835
UNKNOWN
PHASE2
A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors
NCT05148195
TERMINATED
PHASE2
A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
NCT06792552
RECRUITING
PHASE1
TPC VS. GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
NCT06561763
NOT_YET_RECRUITING
PHASE3
Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
NCT06509009
RECRUITING
PHASE2
Targeted or Chemotherapy Combined With Immunotherapy Versus Chemotherapy for PD-1 Inhibitor Refractory R/M NPC
NCT05549466
UNKNOWN
PHASE2
A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
NCT05956587
RECRUITING
PHASE2
Phase I Clinical Study of Metatinib Tromethamine Tablet
NCT02004548
COMPLETED
PHASE1
A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT05949606
RECRUITING
PHASE1/PHASE2
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma
NCT05126719
ACTIVE_NOT_RECRUITING
PHASE2
Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors
NCT05718219
ACTIVE_NOT_RECRUITING
PHASE1
Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma
NCT02871518
UNKNOWN
PHASE2
A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC
NCT05044897
ACTIVE_NOT_RECRUITING
PHASE2
Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma
NCT03668730
UNKNOWN
PHASE2
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors
NCT05315167
RECRUITING
PHASE1/PHASE2
Chronomodulated Chemotherapy Followed by Concurrent Chemo-radiotherapy With IMRT in the Treatment of Advanced Nasopharyngeal Cancer
NCT02937519
UNKNOWN
PHASE2
The Purpose of This Study is to Evaluate the Safety, Tolerability and Efficacy of TMT101 Injection Monotherapy in Patients With Advanced Pancreatic Cancer or Non-small Cell Lung Cancer(NSCLC)
NCT06861543
RECRUITING
PHASE1
SG2918 For Advanced Malignant Tumors
NCT06167486
RECRUITING
PHASE1
First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
NCT02937116
COMPLETED
PHASE1