Solid Tumor Clinical Trial
Official title:
A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications
Verified date | July 2022 |
Source | Jiangsu HengRui Medicine Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.
Status | Active, not recruiting |
Enrollment | 193 |
Est. completion date | December 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Able and willing to provide signed informed consent form, and able to comply with all procedures. - Histologically or cytologically proven metastatic or locally advanced solid tumors. - Male or female subjects aged 18-75 years. - Life expectancy >= 12 weeks as judged by the Investigator. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry. - Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply. Exclusion Criteria: - Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor. - Anticancer treatment within 28 days before the first dose of study drug. - Major surgery within 28 days before start of trial treatment. - Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment. - With any active autoimmune disease or history of autoimmune disease. - With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention. - Clinically significant cardiovascular and cerebrovascular diseases - History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy. - Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. - Receipt of any organ transplantation, including allogeneic stem-cell transplantation Other protocol-defined exclusion criteria could apply |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chest Hospital,Capital Medical University-Integrated Department | Beijing | |
China | Tumor Hospital of the Chinese Academy of Medical Sciences | Beijing | |
China | Cancer Hospital of Hunan Province | Changsha | Hunan |
China | Hunan Cancer Hospital-Gynecologic Oncology | Changsha | Hunan |
China | Chongqing Cancer Hospital | Chongqing | |
China | ChongQing Cancer Hospital-gynecologic oncology | Chongqing | |
China | The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center | Guangzhou | Guangzhou |
China | Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
China | Anhui Chest Hospital-Departmen of Tumor Radiotherapy | Hefei | Anhui |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | The First Affiliated Hospital Of Nanchang University | Nanchang | Jiangxi |
China | Jangsu Cancer Hospital | Nanjing | Jiangsu |
China | The First Hospital of China Medical University-Department of Oncology | Shenyang | Liaoning |
China | The First Rffiurted Hospital of Soochow University | Suzhou | Jiangsu |
China | Xinxiang Central Hospital-Department of Respiratory Physicians | Xinxiang | Henan |
China | The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose escalation part: Safety and tolerability of SHR-1701 in advanced malignancies. | Number of Subjects who occurs dose-limiting toxicity (DLTs). | Up to 3/4 weeks. | |
Primary | Clinical expansion Part: Objective Response Rate(ORR) | ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1. | Up to 6 weeks | |
Secondary | Clinical expansion Part: Safety of SHR-1701 | Number of subjects who occurs treatment-related Adverse Events(AEs) | Up to 4 weeks after last treatment | |
Secondary | Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1 | DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1. | Up to 6 weeks | |
Secondary | Clinical expansion Part: Duration of Response (DOR)per RECIST1.1 | DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 | Up to 6 weeks | |
Secondary | Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1 | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 | 12months (anticipated) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05580991 -
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
Recruiting |
NCT05159388 -
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Recruiting |
NCT06014502 -
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05981703 -
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04107311 -
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
|
||
Active, not recruiting |
NCT04078152 -
Durvalumab Long-Term Safety and Efficacy Study
|
Phase 4 | |
Completed |
NCT02250157 -
A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT05566574 -
A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03943004 -
Trial of DFP-14927 in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06036836 -
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
|
Phase 2 | |
Recruiting |
NCT05525858 -
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
|
||
Recruiting |
NCT05798546 -
Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)
|
Phase 1 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT00479128 -
Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04143789 -
Evaluation of AP-002 in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04550663 -
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 |