Malunga-nomhlaza / unyango / ulingo lweklinikhi / isifo / ithambo-lethambo-sarcoma / unyango
Uvavanyo lweeKlinikhi zovavanyo lweTissue Tissue Sarcoma
Uvavanyo lwezonyango zizifundo zophando ezibandakanya abantu. Uvavanyo lweklinikhi kolu luhlu lonyango oluthambileyo lwe-sarcoma yonyango. Zonke izilingo ezikuluhlu ziyaxhaswa yi-NCI.
Ulwazi olusisiseko lwe-NCI malunga nolingo lweklinikhi luchaza iintlobo kunye nezigaba zovavanyo kunye nendlela ezenziwa ngayo. Uvavanyo lwezonyango lujonga iindlela ezintsha zokuthintela, ukufumanisa, okanye ukunyanga izifo. Unokufuna ukucinga ngokuthatha inxaxheba kuvavanyo lweklinikhi. Thetha nogqirha wakho ngoncedo ekunqumeni ukuba ikulungele na.
I-Erdafitinib ekunyangeni abaguli abaneThumba eziQinisekileyo eziQinisekisiweyo okanye eziPhikisayo, i-non-Hodgkin Lymphoma, okanye ukuphazamiseka kwe-Histiocytic ngoGuqulelo lwe-FGFR (Uvavanyo lweMATCH yoNyango lwabantwana)
Esi sigaba II Izifundo zeMATCH zovavanyo lweMATCH zisebenza njani i-erdafitinib isebenza ekunyangeni abaguli abanamathumba aqinileyo, i-non-Hodgkin lymphoma, okanye iingxaki ze-histiocytic ezisasazeke kwezinye iindawo emzimbeni kwaye zabuya okanye zingaphenduli kunyango ngotshintsho lwe-FGFR. I-Erdafitinib inokumisa ukukhula kweeseli zomhlaza ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezili-107
I-Tazemetostat ekunyangeni abaguli abaneThumba eziQinisekileyo eziQinisekisiweyo okanye eziPhikisayo, i-Non-Hodgkin Lymphoma, okanye ukuphazamiseka kwe-Histiocytic kunye ne-EZH2, SMARCB1, okanye i-SMARCA4 Gene Mutations (Uvavanyo lweMATCH yoNyango lwabantwana)
Esi sigaba II Izifundo zeMATCH zovavanyo lweMATCH zisebenza kakuhle njani ekunyangeni abaguli abanezilonda eziqinileyo, i-non-hodgkin lymphoma, okanye ukuphazamiseka kwe-histiocytic ethe yasasazeka kwezinye iindawo emzimbeni kwaye ibuyile okanye ayiphenduli kunyango kwaye ine-EZH2, SMARCB1 , okanye utshintsho lwe-SMARCA4. I-Tazemetostat inokumisa ukukhula kweeseli zesisu ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezili-109
I-PI3K / mTOR Inhibitor LY3023414 ekunyangeni abaguli abaneThumba eziQinisekileyo eziQinisekisiweyo okanye eziPhikisayo, i-Non-Hodgkin Lymphoma, okanye ukuphazamiseka kwe-Histiocytic nge-TSC okanye i-PI3K / MTOR Mutations (Isilingo soNyango lwaBantwana)
Isigaba sesi-II Izifundo zovavanyo lweMATCH zovavanyo lwe-PI3K / mTOR inhibitor LY3023414 isebenza ekunyangeni abaguli abanezilonda eziqinileyo, ezingezizo i-Hodgkin lymphoma, okanye iingxaki ze-histiocytic ezine-TSC okanye i-PI3K / MTOR zotshintsho ezisasazeke kwezinye iindawo emzimbeni (metastatic) kunye Babuyele (baphindaphindeka) okanye bangaphenduli kunyango (benqabile). I-PI3K / mTOR inhibitor LY3023414 inokumisa ukukhula kweeseli zomhlaza ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezili-107
I-Palbociclib ekunyangeni abaguli abane-Reapsed okanye Refractory Rb Positive Advanced Solors Tumors, Non-Hodgkin Lymphoma, okanye ukuphazamiseka kwe-Histiocytic ngokuQinisa ukuGuqulwa kwi-Cell Cycle Genes (Isilingo soNyango lwabantwana)
Esi sigaba II Izifundo zeMATCH zovavanyo lweMATCH zisebenza kakuhle njani ekunyangeni abaguli abane-Rb tumors eqinileyo, engeyiyo iHodgkin lymphoma, okanye ukuphazamiseka kwe-histiocytic ngokwenza utshintsho (utshintsho) kwiijikelezo zeseli eziye zasasazeka kwezinye iindawo emzimbeni kwaye zeza umva okanye ungaphenduli kunyango. I-Palbociclib inokumisa ukukhula kweeseli zomhlaza ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezingama-97
I-Larotrectinib ekunyangeni abaguli abaneThumba eliQinisekileyo eliQinisekileyo okanye eliPhikisayo, i-non-Hodgkin Lymphoma, okanye ukuphazamiseka kwe-Histiocytic nge-NTRK Fusions (Isilingo soNyango lwaBantwana abaThelekiswayo)
Isigaba sesi-II Izifundo ze-MATCH zovavanyo lwe-MATCH zisebenza kakuhle kangakanani ekunyangeni abaguli abanezilonda eziqinileyo, i-non-Hodgkin lymphoma, okanye ukuphazamiseka kwe-histiocytic kunye ne-NTRK fusions ethe yasasazeka kwezinye iindawo emzimbeni kwaye ibuyile okanye ayiphenduli kunyango. I-Larotrectinib inokumisa ukukhula kweeseli zomhlaza ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezili-109
I-Cabozantinib-S-Malate ekunyangeni abaguli abancinci ngeReccom, Refractory, okanye iSarcomas esandula kufunyaniswa, iWilms Tumor, okanye ezinye iiThumba ezinqabileyo.
Isigaba sesibini sokuvavanywa kwesilingo sendlela esebenza ngayo i-cabozantinib-s-malate ekunyangeni abaguli abancinci abane-sarcomas, ithumba le-Wilms, okanye ezinye izicubu ezinqabileyo eziye zabuya, aziphenduli kunyango, okanye zisanda kufunyaniswa. I-Cabozantinib-s-malate inokumisa ukukhula kweeseli zesisu ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kwethumba kunye nokukhula kwenqanawa yegazi.
Indawo: 137 iindawo
I-Olaparib ekunyangeni abaguli ngeThumba eliQinisekileyo eliHlaziyiweyo okanye eliPhikisayo, i-Non-Hodgkin Lymphoma, okanye ukuphazamiseka kwe-Histiocytic eneZiphene kwi-DNA Umonakalo wokuLungisa iiGenesis (Isilingo soNyango lweZonyango)
Isigaba II Izifundo zeMATCH zovavanyo lwezifo ezisebenza kakuhle ekusebenzeni kakuhle kwe-olaparib ekunyangeni abaguli abanamathumba aqinileyo, i-non-Hodgkin lymphoma, okanye iingxaki ze-histiocytic ezineziphene kwi-deoxyribonucleic acid (DNA) yokulungisa umonakalo osasazeke kwezinye iindawo emzimbeni (phambili) kunye ubuyile (ubuyile kwakhona) okanye akaphenduli kunyango (elichasayo). I-Olaparib inokumisa ukukhula kweeseli zesisu ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezili-105
I-Vemurafenib ekunyangeni abaguli abaneThumba eziQinisekileyo eziQinisekisiweyo okanye eziPhikisayo, i-Non-Hodgkin Lymphoma, okanye ukuphazamiseka kwe-Histiocytic kunye ne-BRAF V600 Mutations (Uvavanyo lwezonyango lwe-MATCH)
Esi sigaba II Izifundo zeMATCH zovavanyo lweMATCH zisebenza njani ekunyangeni abaguli abanezilonda eziqinileyo, ezingezizo zeHodgkin lymphoma, okanye ukuphazamiseka kwembali kunye nokutshintsha kwe-BRAF V600 ethe yasasazeka kwezinye iindawo emzimbeni kwaye ibuyile okanye ayiphenduli kunyango. I-Vemurafenib inokumisa ukukhula kweeseli zesisu ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezili-106
I-Atezolizumab ekunyangeni abaguli abasandula ukufumanisa isifo kunye neMetastatic Alveolar Soft Part Sarcoma engenakususwa ngugqirha
Isigaba sesibini sokuvavanywa kwesilingo sokuba i-atezolizumab isebenza njani ekunyangeni abaguli abane-alveolar soft part sarcoma engakhange inyangwe, isasazekile ukusuka apho yaqala khona ukuya kwezinye iindawo emzimbeni kwaye ayinakususwa ngotyando. I-Immunotherapy ene-monoclonal antibodies, efana ne-atezolizumab, inokunceda amajoni omzimba ahlasele umhlaza, kwaye inokuphazamisa amandla eeseli zethumba ukukhula kunye nokusasazeka.
Indawo: Iindawo ezingama-39
I-Nivolumab kunye ne-Ipilimumab ekunyangeni abaguli abane-HIV Amanyaniswa abuye abuye okanye abonakalise i-Classical Hodgkin Lymphoma okanye ii-Tumors eziQinisekileyo eziMetastatic okanye azinakususwa ngotyando
Eli nqanaba ndilingwa kuvavanyo lweziphumo ebezingalindelekanga kunye nethamo elifanelekileyo le-nivolumab xa inikwa i-ipilimumab ekunyangeni abaguli abane-virus ye-immunodeficiency virus (HIV) ehambelana ne-Hodgkin lymphoma ehambelana nokubuyela emva kwexesha lokuphucula okanye elingaphenduliyo kunyango, okanye amathumba aqinileyo sele zisasazekile kwezinye iindawo emzimbeni okanye azinakususwa ngotyando. I-Immunotherapy ene-monoclonal antibodies, njenge-ipilimumab kunye ne-nivolumab, inokunceda amajoni omzimba ahlasele umhlaza, kwaye inokuphazamisa ukubanakho kweeseli zethumba ukukhula kunye nokusasazeka. I-Ipilimumab yintsholongwane esebenza ngokuchasene nemolekyuli ebizwa ngokuba yi-cytotoxic T-lymphocyte antigen 4 (CTLA-4). I-CTLA-4 ilawula icandelo lamajoni akho omzimba ngokuwavala. I-Nivolumab luhlobo lwe-antibody ekhethekileyo yokufa kweseli okucwangcisiweyo kwabantu 1 (PD-1), iprotheni ejongene nokutshatyalaliswa kweeseli zomzimba. Ukunika i-ipilimumab nge-nivolumab kunokusebenza ngcono ekunyangeni abaguli abane-HIV enxulumene ne-Hodgkin lymphoma okanye i-tumors eqinileyo xa kuthelekiswa ne-ipilimumab ene-nivolumab yodwa.
Indawo: Iindawo ezingama-28
I-MDM2 Inhibitor AMG-232 kunye nonyango lweRadiation ekunyangeni abaguli abaneTissue Tissue Sarcoma
Esi sigaba Uvavanyo lwe-Ib lujonga iziphumo ebezingalindelekanga ze-MDM2 inhibitor AMG-232 kunye nonyango lwemitha ekunyangeni abaguli abane-sarcoma ethambileyo. I-MDM2 inhibitor i-AMG-232 inokumisa ukukhula kweeseli zomhlaza ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli. Ukunika i-MDM2 inhibitor i-AMG-232 kunye nonyango lwemitha ngaphambi kotyando kunokwenza ukuba ithumba libe lincinci kwaye kunciphise inani lezihlunu eziqhelekileyo ekufuneka zisuswe.
Indawo: Iindawo ezingama-27
I-Nivolumab kunye okanye ngaphandle kwe-Ipilimumab ekunyangeni abaguli abancinci abaneeTumor eziQhelekileyo okanye eziPhambeneyo okanye iSarcomas
Esi sigaba sokulinga se-I / II sophando lweziphumo ebezingalindelekanga kunye neyona dosi ilungileyo ye-nivolumab xa inikwa kunye okanye ngaphandle kwe-ipilimumab ukubona ukuba isebenza njani ekunyangeni abaguli abancinci abanezilonda eziqinileyo okanye ii-sarcomas ezibuyileyo (eziphindayo) okanye ezingaphenduliyo kunyango ( Ukuchasana). I-Immunotherapy ene-monoclonal antibodies, enje nge-nivolumab kunye ne-ipilimumab, inokunceda amajoni omzimba ahlasele umhlaza, kwaye inokuphazamisa amandla eeseli zethumba ukukhula kunye nokusasazeka. Akukaziwa ukuba i-nivolumab isebenza bhetele yodwa okanye i-ipilimumab ekunyangeni abaguli abanezilonda eziphindaphindayo okanye ezinqabileyo eziqinileyo okanye ii-sarcomas.
Indawo: Iindawo ezingama-24
I-Selinexor kwi-Advanced Liposarcoma
Olu luhlu olungenamkhethe, oluninzi, oluyimfama, olulawulwa yi-placebo, Isigaba se-2-3 sifundo sezigulana ezifunyenwe zine-liposarcoma engenakuphikiswa. Malunga nezigulana ezingama-279 zizonke ziya kulungiswa ukufundisisa unyango (i-selinexor okanye i-placebo).
Indawo: Iindawo ezingama-21
(VOYAGER) Isifundo se-Avapritinib vs Regorafenib kwizigulana ezinendawo engapheliyo engabonakaliyo okanye iMetastatic GIST
Le yileyibhile evulekileyo, engacwangciswanga, isifundo seSigaba 3 kwizigulana ezinendawo engaphambekiyo engafumanekiyo okanye ye-metastatic GIST (i-GIST ephambili) ye-avapritinib (ekwabizwa ngokuba yi-BLU-285) xa ithelekiswa ne-regorafenib kwizigulana ezazinyangwa ngaphambili nge-imatinib kunye ne-1 okanye 2 ezinye ii-TKIs.
Indawo: Iindawo ezili-14
Isigaba 1 soFundo lwe-EZH2 Inhibitor Tazemetostat kwizifundo zabantwana ezinokubuyela umva okanye ukuphikisa i-INI1-Negative Tumors okanye iSynovial Sarcoma
Eli linqanaba lesi-I, ileyibhile evulekileyo, ukunyuka kwedosi kunye nokwandiswa kwethamo kunye nedosi yomlomo ye-BID ye-tazemetostat. Izifundo ziya kuvavanywa ukufaneleka ukuba zingabikho kwiintsuku ezili-14 zedosi yokuqala ecwangcisiweyo ye-tazemetostat. Umjikelo wonyango uyakuba ziintsuku ezingama-28. Uvavanyo lwempendulo luya kuvavanywa emva kweeveki ezisi-8 zonyango kwaye emva koko rhoqo emva kweeveki ezisi-8 ngelixa usenza isifundo. Isifundo sinamacandelo amabini: Ukunyuka kweDosi kunye nokwandiswa kweDose. Ukunyuka kwedosi kwizifundo ngezi zilandelayo: :
Indawo: Iindawo ezili-14
I-Adavosertib kunye ne-Irinotecan Hydrochloride ekunyangeni abaguli abancinci abanamaThumba aQinisekileyo abuye abuye
Esi sigaba sokulinga se-I / II sophando lweziphumo ebezingalindelekanga kunye neyona ithamo ilungileyo ye-adavosertib kunye ne-irinotecan hydrochloride ekunyangeni abaguli abancinci abanezilonda eziqinileyo eziye zabuya (zabuya) okanye ezingaphendulanga kunyango oluqhelekileyo (elichasayo). I-Adavosertib kunye ne-irinotecan hydrochloride inokumisa ukukhula kweeseli zesisu ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezingama-22
Isilingo sesiGaba sesi-III se-Anlotinib kwi-Metastatic okanye kwi-Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma kunye neSynovial Sarcoma
Olu phononongo luvavanya ukhuseleko kunye nokusebenza kwe-AL3818 (anlotinib) hydrochloride kunyango lwe-metastatic okanye advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), kunye ne-synovial sarcoma (SS). Bonke abathathi-nxaxheba abane-ASPS baya kufumana iilebhile ezivulekileyo AL3818. Kubathathi-nxaxheba abane-LMS okanye i-SS, i-AL3818 iya kuthelekiswa ne-IV dacarbazine. Isibini kwisithathu sabathathi-nxaxheba baya kufumana i-AL3818, isinye kwisithathu sabathathi-nxaxheba baya kufumana i-IV dacarbazine.
Indawo: Iindawo ezili-14
I-Nab-Paclitaxel kunye ne-Gemcitabine Hydrochloride ekuNyangeni abaFikisayo okanye kuBantu abaDala abaDala nge-Osteosarcoma, i-Ewing Sarcoma, iRhabdomyosarcoma, okanye iSoft Tissue Sarcoma
Isigaba sesibini sokuvavanywa kwesilingo sendlela esebenza kakuhle ngayo i-nab-paclitaxel kunye ne-gemcitabine hydrochloride ekunyangeni ulutsha okanye abantu abadala abancinci abane-osteosarcoma, i-Ewing sarcoma, i-rhabdomyosarcoma, okanye i-sarcoma ethambileyo ebuyileyo okanye engaphenduliyo kunyango. Iziyobisi ezisetyenziswa kwi-chemotherapy, ezinje nge-nab-paclitaxel kunye ne-gemcitabine hydrochloride, zisebenza ngeendlela ezahlukeneyo ukunqanda ukukhula kweeseli zethumba, nokuba kungokubulala iiseli, ngokuzinqanda ekwahluleni, okanye ngokuzinqanda zisasazeke.
Indawo: Iindawo ezili-18
I-Olaparib kunye neTemozolomide ekunyangeni abaguli abane-Advanced, Metastatic, okanye i-Uterine Leiomyosarcoma engabonakaliyo.
Esi sigaba sesibini sophando lwe-olaparib kunye ne-temozolomide ekunyangeni abaguli abane-uterine leiomyosarcoma (LMS) ethe yasasazeka kwezinye iindawo emzimbeni (phambili okanye kwimetastatic) okanye ayinakususwa ngotyando (olungafumanekiyo). I-Olaparib inokumisa ukukhula kweeseli zesisu ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli. Iziyobisi ezisetyenziswa kwi-chemotherapy, njenge-temozolomide, zisebenza ngeendlela ezahlukeneyo ukunqanda ukukhula kweeseli zethumba, nokuba kungokubulala iiseli, ngokuzinqanda ekwahluleni, okanye ngokuzinqanda zisasazeke. Ukunika i-olaparib kunye ne-temozolomide kunokusebenza ngcono kunokunika ichiza lodwa ekunyangeni abaguli abane-LMS.
Indawo: Iindawo ezili-12
Ukhuseleko, ukunyamezeleka kunye ne-PK Study yeDCC-2618 kwizigulana ezineZenzo eziPhuthileyo
Eli linqanaba 1, ileyibhile evulekileyo, isifundo sokuqala-somntu (i-FIH) sonyuko lokunyusa idosi eyilelwe ukuvavanya ukhuseleko, ukunyamezeleka, i-pharmacokinetics (PK), i-pharmacodynamics (PD) kunye nomsebenzi wokuqala we-antitumor weDCC-2618, elawulwa ngomlomo (PO), kwizigulana zabantu abadala ezineempawu ezimbi. Isifundo sineenxalenye ze-2, isigaba sokwanda kwethamo kunye nenqanaba lokwandiswa.
Indawo: Iindawo ezili-12
UNelfinavir Mesylate ekuNyangeni abaguli abaneKaposi Sarcoma
Isigaba sesibini sokulinga silinganisa ukuba i-nelfinavir mesylate isebenza njani ekunyangeni abaguli abane-Kaposi sarcoma. I-Nelfinavir mesylate inokumisa ukukhula kweeseli zesisu ngokuthintela ezinye ii-enzymes ezifunekayo ekukhuleni kweseli.
Indawo: Iindawo ezili-11
I-EpB4-HSA ekunyangeni abaguli abaneKaposi Sarcoma
Esi sigaba sesibini sophando lwe-EphB4-HSA protein fusion (sEphB4-HSA) ekunyangeni abaguli abane-Kaposi sarcoma. Iprothini ye-fB4-HSA ye-Recombinant EphB4-HSA inokuthintela ukukhula kwemithambo yegazi ebonelela ngegazi kumhlaza, kwaye inokuthintela iiseli zomhlaza ekukhuleni.
Indawo: Iindawo ezili-10
Isigaba II, uPhononongo lweMulticenter ye-EZH2 Inhibitor Tazemetostat kwizifundo zabantu abadala ezine-INI1-Negative Tumors okanye ezibuyisiweyo / eziPhambeneyo zeSynovial Sarcoma
Eli linqanaba lesiBini II, imulticenter, ileyibhile evulekileyo, ingalo enye, inqanaba le-2 lokufunda nge-tazemetostat 800 mg BID elawulwa ngomlomo kwimijikelo yeentsuku ezingama-28 eziqhubekayo. Ukuvavanywa kwezifundo ukumisela ukufaneleka kwesifundo kuya kwenziwa kwiintsuku ezingama-21 zokuqala kwethamo elicwangcisiweyo le-tazemetostat. Izifundo ezifanelekileyo ziya kubhaliswa kwesinye sotywala ezintlanu ngokusekwe kuhlobo lwethumba: -Iqela 1 (livaliwe ukuze ubhalise): I-MRT, i-RTK, i-ATRT, okanye amathumba akhethiweyo aneempawu ze-rhabdoid, kubandakanya ne-cell carcinoma encinci ye-ovary hypercalcemic type [SCCOHT], nayo eyaziwa ngokuba yithumba elibi eline-rhaboid le-ovary [MRTO] - Iqela lesi-2 (livaliwe ukuze ubhalise): I-synoomaal sarcoma ebuyayo okanye ephikisayo ene-SS18-SSX yokulungiswa kwakhona-Iqela labantu 3 (livaliwe ukuze kubhaliswe): Ezinye izilonda ezimbi ze-INI1 okanye naliphi na ithumba eliqinileyo eline-EZH2 Inzuzo yokusebenza (GOF) yotshintsho, kubandakanya:
Indawo: Iindawo ezili-12
I-SARC024: IProtokholi yeNgubo yokuFunda i-Ororafenib yomlomo kwizigulana ezikhethiweyo zeSarcoma
Nangona i-regorafenib yavunywa ukuba isetyenziswe kwizigulana ezazine-GIST eqhubekayo ngaphandle kwe-imatinib kunye / okanye i-sunitinib kwisiseko sesigaba II kunye nedatha yesigaba III, ayikhange ihlolwe ngendlela echanekileyo kwizigulana ezinezinye iindlela zesarcoma. Ngenxa yomsebenzi we-sorafenib, i-sunitinib kunye ne-pazopanib kwi-sarcomas ethambileyo, kunye nobungqina bomsebenzi we-sorafenib kwi-osteogenic sarcoma kunye ne-Ewing / Ewing-like sarcoma, kukho umzekelo wokuvavanya ii-SMOKIs (i-molecule encinci yomlomo we-kinase inhibitors) njenge-regorafenib kwi-sarcomas ngaphandle kweGIST. Kuyaqatshelwa ukuba ii-SMOKIs (i-molecule encinci yomlomo we-kinase inhibitors) ezinje nge-regorafenib, i-sorafenib, i-pazopanib, kunye ne-sunitinib ineepaneli ezigqagqeneyo ze-kinase ezithintelwe ngaxeshanye. Ngelixa lingalingani,
Location: 10 locations
Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of Toripalimab, 2) evaluate antitumor activity of Toripalimab; 3) determine the immunogenicity of Toripalimab; 4) evaluate overall survival. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of Toripalimab, 2) evaluate pharmacodynamic effects of Toripalimab on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. 3) evaluate the utility of PD-L1 & additional exploratory markers as biomarkers that could aid in selection of appropriate subjects for TAB001 therapy, and 4) identification of additional biomarkers correlating with response to treatment with TAB001.
Indawo: Iindawo ezi-9
