Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Recombinant Human Anti-PD-1 Monoclonal Antibody

Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.

SG001

Beibei Zhai

Lingying Wu, Medical PhD

This study is an open, single-arm, multicenter phase II study to investigate the efficacy and safety of SG001 for relapsed or metastatic uterine cervical cancer patients with PD-L1 positive (CPS≧1), and has failed at least first line platinum-based chemotherapy.

Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer

A Single-arm, Open-label, Multicenter, Phase II Study for Evaluation of Efficacy and Safety of the SG001 Injection for Patients With PD-L1-positive Relapsed or Metastatic Uterine Cervical Cancer

To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.

To investigate the safety and tolerance profile of SG001 in patients with relapsed or metastatic uterine cervical cancer.

To investigate the immune profile of SG001.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

Irinotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

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

JMT101

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

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)

Clinical Trials Information Group officer

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)

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.

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

Shanghai JMT-Bio Inc.

Rare Diseases

Carcinoma

Cholangiocarcinoma

Biliary Tract Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Micronutrients

Hematinics

Vitamins

Leucovorin

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or termination of the study for other reasons.

The patients in cohort 1 will receive irinotecan liposome injection combined with SG001, 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or until 24 months is reached, or the study is terminated for other reasons.

Irinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL

Irinotecan Liposome Injection

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL

5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle

Leucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle

Xiangdong Cheng, Ph.D

Xiangdong Cheng

This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer.

This is an open-label, parallel, multicentre, phase II study to evaluate the efficacy and safety of irinotecan liposome injection. Eligible patients will be divided into two cohorts according to the criteria for the corresponding cohort. The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV). The patients in cohort 2 will receive irinotecan liposome injection combined with a PD-1 inhibitor, 5-Fluorouracil and Leucovorin.

Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

The percentage of patients who achieve a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Time from date of the first dose to date of recorded disease progression or death, whichever occurs first

Time from date of the first dose to date of death from any cause

The percentage of patients who achieve a CR, PR or stable disease (SD) based on the RECIST 1.1

Time from first documented response (CR or PR whichever occurs first, based on investigator's assessment per RECIST 1.1) to date of disease progression or death due to any cause, whichever occurs first

The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0

CSPC Ouyi Pharmaceutical Co., Ltd.

Carcinoma, Squamous Cell

Neoplasms, Squamous Cell

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; Docetaxel for Injection (Albumin-bound) (HB1801), Intravenous infusion, D1, Q3W, 60 or 75 mg/m\^2, up to 2 cycles; cisplatin for injection 25 mg/m\^2, D1-D3, Q3W, up to 2 cycles; radiotherapy (28×1.8Gy).All treatments will be administered until disease progression or intolerable toxicity.

Paclitaxel 135 mg/m\^2, Intravenous infusion, D1, Q3W; cisplatin for injection 25 mg/m\^2, D1-D3, Q3W, radiotherapy (28×1.8Gy). No other systemic antineoplastic therapy is allowed until disease progression, optimal supportive care and local palliative care are allowed.

Docetaxel for Injection (Albumin-bound) 60 or 75 mg/m\^2, Intravenous infusion, Q3W

Docetaxel for Injection (Albumin-bound)

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 360 mg, Intravenous infusion, Q3W

Cisplatin for injection, 25 mg/m\^2, Intravenous infusion, D1-D3, Q3W

Cisplatin for injection

Paclitaxel 135 mg/m\^2, Intravenous infusion, Q3W

Simultaneous Radiotherapy

Jin ming Yu

Qing song Pang

The study is a multicenter, open-label, phase Ib/II study to evaluate the efficacy and safety of docetaxel for injection (albumin-bound) (HB1801) and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma.

This study will be conducted in two stages. The first stage (Phase Ib) is a dose-escalation study designed to determine the safety and the recommended Phase 2 dose (RP2D) of HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma. Patients will be assigned to receive sequentially higher doses of HB1801 once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 60 mg/m\^2. The second stage (Phase II) is a study to evaluate the efficacy and safety of HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.

A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.

A Multicenter, Open-label, Phase Ib/II Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy Versus Paclitaxel in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.

Patients will oral administration according to study protocol until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.

Simmitinib

Patients will receive intravenous infusion of SG001 according to study protocol until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.

Lingying Wu

This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I.

A Study of Simmitinib Plus SG001 in Advanced Solid Tumors

A Phase I/II Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Simmitinib Plus SG001 in Patients With Advanced Solid Tumors

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Duvelisib combine with SG001 injection regimen in patients who had failed with prior PD-1/PD-L1 therapy

Duvelisib combine with SG001 injection regimen in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1.

SG001 monotherapy in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1

Duvelisib PR2D bid po. until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.

Duvelisib

240mg, each two weeks,iv,until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.

Lin Shen

The first stage will explore the suitable dose of duvelisib when combined with SG001 injection in patients with advanced solid tumors who had failed with prior systemic therapy.

The second stage will explore the safety and tolerability, preliminary anti-tumor efficacy and PK data of duvelisib monotherapy and combo regime with SG001 injection in patients with advanced solid tumors which will including but not limited with esophageal carcinoma, gastric carcinoma, colorectal cancer and head and neck squamous carcinoma.

A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors

A Multi-centre, Randomized, Open-label, Phase 1/2 Trial to Investigate the Safety, Tolerability, and Preliminary Anti-cancer Efficacy of Duvelisib Combined With SG001 Injection in Advanced Solid Tumours

When the research is completed, we will publish the results in the form of conference reports and papers.

The correlation of PIK3CA, AKT mutations, TMB and PD-L1 expression and other biomarkers with the efficacy of duvelisib will be assessed.

Number of patients with dose limiting toxicity

Number of patients with treatment-emergent adverse events

Number of patients with treatment-related Adverse Events

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Patients will receive SG001 intravenously at a dose of 240 mg on Days 1 and 15 of every 4-week cycle in combination with nab-paclitaxel at a dose of 100 mg/m\^2 on Days 1, 8, and 15 of every 4-week cycle until disease progression, or unacceptable toxicity, or other discontinuation or termination criteria are met.

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg, i.v., q2w

Paclitaxel for Injection (Albumin Bound), 100 mg/m\^2, i.v., D1, D8, D15 of every 4-week cycle

Nab-paclitaxel

beibei Zhai

herui yao, M.D

ying wang, M.D

herui yao

wang ying

This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of SG001 in combination with Nab-paclitaxel in patients with advanced TNBC.

This study is a single-arm, open label, multicenter phase II study to evaluate the efficacy and safety of SG001 in combination with nab-paclitaxel in patients with unresectable locally advanced, or recurrent, or metastatic TNBC. Eligible patients will receive SG001 intravenous infusion at a dose of 240 mg on Days 1 and 15 of every 4-week cycle and nab-paclitaxel intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 8, and 15 of every 4-week cycle until disease progression, or intolerable toxicity, or other discontinuation or termination criteria are met, for a maximum of 2 years.

A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)

A Single-arm, Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)

Clinical characteristics includes intestinal flora, gene mutations, PD-L1 expression, biomarkers, etc.

ORR will be assessed by RECIST 1.1 criteria.

Plasma Concentrations of Total and Free Paclitaxel

Anti-drug antibodies (ADA) and neutralizing antibodies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer	NCT04886700	Uterine Cervica...	SG001	18 Years -	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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.
Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer	NCT05009953	Advanced Biliar... Intrahepatic Ch... Extrahepatic Ch... Gallbladder Car...	Irinotecan Lipo... SG001 Fluorouracil Leucovorin	18 Years -	CSPC Ouyi Pharmaceutical Co., Ltd.
A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.	NCT06136988	Locally Advance...	Docetaxel for I... SG001 Cisplatin for i... Paclitaxel Simultaneous Ra...	18 Years -	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Study of Simmitinib Plus SG001 in Advanced Solid Tumors	NCT06132217	Advanced Solid ...	Simmitinib SG001	18 Years - 75 Years	Shanghai Runshi Pharmaceutical Technology Co., Ltd
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.
A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors	NCT05508659	Advanced Solid ...	Duvelisib SG001	18 Years -	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)	NCT05068141	Triple Negative...	SG001 Nab-paclitaxel	18 Years - 70 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Spots Global Cancer Trial Database for sg001

Every month we try and update this database with for sg001 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 sg001

Every month we try and update this database with for sg001 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 sg001 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.