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This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 used as a single agent and in combination with systemic therapies in patients with advanced hematological and solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental |
| |
| Dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS5001 | Drug | The dose and dosing schedule is decided by the Safety Monitoring Committee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part) | Participants will receive CS5001 for injection once every three weeks. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT). | About 6 months |
| Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part) | The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range. | About 6 months |
| Incident and severity of adverse events | Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first | |
| Objective Response Rate (ORR) (for dose expansion) | The percentage of participants with a CR or PR based on 2014 Lugano Classification Criteria for lymphomas, iwCLL 2018 guidelines for CLL/SLL and RECIST v1.1 for solid tumors. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of CS5001 total antibody | Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first | |
| Concentration of anti-CS5001 antibodies | Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part) | About up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystal Wang | Contact | 021-60332435 | wangjingru@cstonepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore Hematology Oncology Associates | Recruiting | East Setauket | New York | 11733 | United States |
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| Rituximab | Biological | IV infusion |
|
| Gemcitabine | Drug | IV infusion |
|
| Oxaliplatin | Drug | IV infusion |
|
| Lenalidomide | Drug | PO |
|
| Cyclophosphamide | Drug | IV infusion |
|
| Doxorubicin | Drug | IV infusion |
|
| Vincristine | Drug | IV infusion |
|
| Prednisone | Drug | PO |
|
| Columbia U. - Herbert Irving Comprehensive Cancer Center | Recruiting | New York | New York | 10032 | United States |
|
| BUMC - Mary Crowley Cancer Research Centers (MCCRC) | Recruiting | Dallas | Texas | 75201-7307 | United States |
|
| Scientia Clinical Research Limited | Recruiting | Randwick | New South Wales | 2031 | Australia |
|
| Ashford Cancer Centre Research | Terminated | Adelaide | South Australia | Australia |
| Central Adelaide Local Health Network Incorporated | Recruiting | Adelaide | South Australia | Australia |
|
| Royal Adelaide Hospital (RAH) | Recruiting | Adelaide | South Australia | Australia |
|
| Epworth Freemasons Medical Centre | Recruiting | East Melbourne | Victoria | Australia |
|
| Epworth Foundation trading as Epworth HealthCare | Not yet recruiting | Melbourne | Victoria | Australia |
|
| Anhui Provincial Cancer Hospital | Not yet recruiting | Hefei | Anhui | China |
|
| Anhui Provincial Hospital, | Not yet recruiting | Hefei | Anhui | China |
|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Cancer Hospital | Terminated | Beijing | Beijing Municipality | China |
| Yanda Lu Dao Pei Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The Cancer Hospital Affiliated to Chongqing University | Recruiting | Chongqing | Chongqing Municipality | China |
|
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | China |
|
| Guangdong Province Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Sun YatSen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Guangxi Medical University Affiliated Tumour Hospital | Recruiting | Nanning | Guangxi | China |
|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
|
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | China |
|
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
|
| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | China |
|
| Jiangsu province hospital | Not yet recruiting | Nanjing | Jiangsu | China |
|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhu | Jiangsu | China |
|
| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
|
| The Second Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | China |
|
| The first Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | China |
|
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | China |
|
| Fudan University Shanghai Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai Pulmonary Hospital | Terminated | Shanghai | Shanghai Municipality | China |
| Shanxi Provincial Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | China |
|
| First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D000077269 | Lenalidomide |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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