As of 01 March 2013, OSI-906 is no longer being administered

OSI-906

Erlotinib

As of 01 March 2013, the matching placebo is no longer being administered

Placebo

Eligible subjects randomized to Arm 1 will receive an intravenous (IV) infusion of OTL-203 gene therapy. Subjects will receive conditioning regimen with busulfan and fludarabine prior to OTL-203 infusion.

Experimental: OTL-203: Autologous CD34+ enriched cell fraction that contains hematopoietic stem and progenitor cells transduced ex vivo using lentiviral vector encoding the human IDUA gene

Experimental: OTL-203

Eligible subjects randomized to Arm 2 will receive allogeneic hematopoietic stem cell transplantation. Subjects will receive conditioning regimen with busulfan and fludarabine prior to allo-HSCT.

Active Comparator: Allogeneic hematopoietic stem cell transplantation

Active Comparator: Allo-HSCT

Dose: 800 mg/m2 intravenously (IV) Frequency: administered on Day 1, Day 8, and Day 15 of each cycle (every 4 weeks)

Gemcitabine

Dose: fixed dose of 1.2 mg subcutaneously (SC) Frequency: administered on Day 1 and Day 15 of each cycle starting at Cycle 2 (every 4 weeks) and when the last dose of M-CENK is administered, N-803 will be administered on Days 1 and 15 of the same cycle followed by 3 additional doses, 2 weeks apart (total of 5 N-803 doses).

N-803

Dose: 0.15 to 0.75 × 109 cells per infusion intravenously (IV) Frequency: administered on Day 1 of each cycle as long as M-CENK cells are available.

M-CENK

Jacqui Parnin

Jaya (Mini) Gill

Chaitali Nangia, MD

Tiffany Beck, M.D., MPH, FACOG

Ana Navarrete

Tiffany L Beck, M.D., MPH, FACOG

SAR441344 single intravenous (IV) loading dose on Day 1 followed by a single subcutaneous (SC) dose administered once every 2 weeks from Week 2 to Week 10 (5 administrations)

Pharmaceutical form: solution for injection

Route of administration: intravenous or subcutaneous

SAR441344

NTI164 is a full-spectrum medicinal cannabis plant extract with \<0.3% THC.

NTI164

Kanan Sharma

Arm 1 receives ONC-392 3 mg/kg, IV infusion, Q4W for up to 13 doses, plus lutetium Lu 177 vipivotide tetraxetan IV infusion, Q6W for up to 6 doses.

ONC-392 will be given as IV infusion, Q4W for up to 13 doses.

ONC-392 low

lutetium Lu 177 vipivotide tetraxetan will be given as IV infusion, Q6W, for up to 6 doses.

lutetium Lu 177 vipivotide tetraxetan

Arm 2 receives ONC-392 6 mg/kg, IV infusion, Q6W for up to 9 doses, plus lutetium Lu 177 vipivotide tetraxetan IV infusion, Q6W for up to 6 doses.

ONC-392 will be given as IV infusion, Q6W for up to 9 doses.

ONC-392 high

Arm 3 receives lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses.

Sevasemten is administered orally once per day

Sevasemten Dose 1

Placebo is administered orally once per day

Sevasemten Dose 2

Sevasemten Dose 3

Following a 3 + 3 dose escalation design 6-18 participants will receive NIS793 and FOLFIRINOX on day 1 of each 14 day cycle for 3+ cycles until recommended phase 2 dose is determined.

Combination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion

FOLFIRINOX

NIS793

Participants will be randomly assigned to receive:

* FOLFIRINOX on day 1 of each 14 day cycle for cycles 1-8
* Cycles 9+: Chemoradiation (CRT) and surgery

Part of the FOLFIRINOX drug combination, given by intravenous infusion

Oxaliplatin

Leucovorin

Irinotecan

5-Fluorouracil (5-FU)

Combination of Chemo (Capecitabine) and Radiation Therapy

Chemoradiation

Capecitabine

Radiation Therapy as part of Chemoradiation

Radiation Therapy

Surgery

Participants will be randomly assigned to receive:

* FOLFIRINOX FOLFIRINOX + NIS793 on day 1 of each 14 day cycle for cycles 1-8
* Cycles 9+: Chemoradiation (CRT) with NIS793, Surgery, NIS793

This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.

ZG006 will be administered as an intravenous (IV) infusion.

ZG006

ZG005 will be administered as an intravenous (IV) infusion.

ZG005

The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.

Part A: Ascending doses of AZD5363 administered orally, every day to define the maximum tolerated dose. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A.

Patients will receive a single dose of AZD5363, administered orally, followed by a 3-7 day wash-out period. Patients will then commence with twice-daily dosing, administered orally, every day, to cessation of therapy.

AZD5363

Part A: Ascending doses of AZD5363 administered orally, twice daily, on a 7-day repeating regimen (4 days on, 3 days off and 2 days on, 5 days off), to define the maximum tolerated dose. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A (4 days on, 3 days off and 2 days on, 5 days off). Part C and D: AZD5363 orally, twice daily on an intermittent regimen (4 days on, 3 days off).

Patients will be given AZD5363 administered orally as a single dose, followed by a 3-7 day wash-out period. Patients will then receive AZD5363 twice daily on 6 or fewer days per weekly regimen, to cessation of therapy. Parts C,D: Oral AZD5363 twice daily, 4 days on treatment, 3 days off treatment, to cessation of therapy.

Part A: Ascending doses of AZD5363 administered orally, twice daily, on an alternative weekly regimen. Initiation of Schedule 3 is dependant on emerging clinical data.

Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A

Optional additional schedule. Patients will be given AZD5363 administered orally. Regimen to be determined in response to emerging clinical findings.

Oral AZD5363 twice daily, 4 days on treatment, 3 days off treatment to cessation of therapy combined with background therapy of fulvestrant at its licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter to cessation of therapy.

Patients will receive oral AZD5363 twice daily (4 days on 3 days off treatment)combined with background therapy of fulvestrant at licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter.

Participants will receive Dose A of ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.

Subcutaneous (SC) ABBV-383

Intravenous (IV) ABBV-383

Participants will receive Dose B of ABBV-383 as an SC injection and IV infusions, during the 151 week study duration.

Participants will receive the selected dose from Arm A of ABBV-383 as SC injections, during the 151 week study duration.

XELOX/FOLFOX4+ Adebelizumab + Apatinib+Icaritin

FOLFOX4 was administered by oxaliplatin 85 mg/m² d1+ leucovorin 200 mg/m² d1-2+ fluorouracil 400 mg/m² 2 h→ 600 mg/m² 24 h d1-2 q2w, with a total of 4 cycles

FOLFOX4

Adebrelimab 1200mg, intravenous infusion, every 3 weeks

Adebrelimab

Apatinib

Epimedium extract soft capsules 2.4g, oral, 2 times daily.

Icaritin

SHR1701，30mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.

SHR-1701

QL1706，5mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.

QL1706

The original targeted combination immunotherapy+HAIC

HAIC

Continue the original targeted therapy combined with immunotherapy. dosage, dosage form,frequency of administration was the same as before.

The original treatment regimen

SHR1701+ Apatinib+Icaritin，intrahepatic progression

QL1706+ Apatinib+Icaritin，extrahepatic progression

Bevacizumab 7.5mg, intravenous infusion, once every 3 weeks.

Bevacizumab

Local treatment of oligometastases (such as radiotherapy, RFA, etc.) + the original targeted and immunotherapy.

Local treatment

Chen Xun

ALLO-316 is an allogeneic CAR T cell therapy targeting CD70

ALLO-316

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

ALLO-647

Fludarabine

Cyclophosphamide

Phase Ib Safety Run-in: JDB153 Monotherapy. Initially, 3 patients will be enrolled to receive JDB153 monotherapy for safety and tolerability assessment prior to combination therapy

JDB153 is administered orally at doses of 600 mg twice daily (1200 mg total daily dose) or 500 mg twice daily (1000 mg total daily dose) based on safety and tolerability assessment.

JDB153

Combination Treatment Phase: JDB153 + Penpulimab. After completing the JDB153 monotherapy safety assessment, patients will receive combination treatment with JDB153 and Penpulimab

Penpulimab is administered by intravenous infusion at a dose of 200 mg once every 3 weeks (Q3W).

Penpulimab

Oral capsule containing lyophilised Lactobacillus reuteri

BGP-014

재단법인아산사회복지재단서울아산병원

근치적 절제수술이 가능한 MMR proficient 위 또는 위식도접합부 선암 환자에서 수술 전 보조항암요법 durvalumab(MEDI4736)/docetaxel/oxaliplatin/S-1 + 수술 + 수술 후 보조항암화학요법 durvalumab/S-1 치료의 임상시험

Treatment for the main treatment group (pMMR tumor)
1. 수술 전 보조요법(neoadjuvant) 치료
3 주기 동안 매 3주마다, 제1일에 durvalumab 1120 mg  정주, docetaxel 50 mg/m2  정주, oxaliplatin 100 mg/m2  정주, S-1 40 mg/m2 제1일~제 14일에 1일 2회 경구투여할 것이다. 첫 번째 durvalumab+DOS 치료 주기 후, 반응 평가를 실시할 것이다. 질병이 진행되면, 환자는 수술을 받거나 시험 이외의 다른 항암화학요법을 받을 것이다. 그렇지 않으면 환자는 두 번째 및 세 번째 주기의 durvalumab+DOS 치료를 계속할 것이다. 세 번째 durvalumab/DOS 주기 후, 수술을 위해 반응 평가와 임상적 병기 결정을 실시할 것이다. 절제가 가능하다면, durvalumab+DOS 3주기의 D1으로부터 4~6주 후 수술을 진행할 것이다.
2. 수술(Surgery) 
원발 종양 병변의 위치에 따라, D2 림프절 절제를 동반한 전체위절제술(TG; total gastrectomy) 또는 원위부위절제술(DG; distal gasectomy)을 시행할 것이다.
3. 수술 후 보조요법(adjuvant) 치료 
수술 4~6주 후, 수술 후 보조요법으로서 12개월 동안 매 6주마다 S-1 40 mg/m2 D1~28에 1일 2회 경구투여 및 durvalumab 1120 mg을 D1, D22에 정맥투여할 것이다. 

Treatment for the exploratory group (dMMR tumor)
1. 수술 전 보조요법(neoadjuvant) 치료
3회의 주기 동안 매 4주마다, 제1일에 durvalumab 1500 mg과 tremelimumab 75 mg을  정주할 것이다. 1cycle과 2cycle에 durvalumab/tremelimumab 치료 후, 반응 평가를 실시할 것이다. 진행이 나타나면, 환자는 수술을 받거나 시험 이외의 다른 항암화학요법을 받을 것이다. 그렇지 않으면 환자는 세 번째 durvalumab/tremelimumab 주기의 치료를 계속할 것이다. 세 번째 durvalumab/tremelimumab 치료 주기 후, 수술을 위해 반응 평가와 임상적 병기 결정을 실시할 것이다. 절제가 가능하다면, 세 번째 durvalumab/tremelimumab 치료 주기의 D1으로부터 4~6주 후 수술을 진행할 것이다. (주: 환자의 체중이 30kg 이하가 되면, 시험자와 시험 담당 의사 간 협의 후 체중기준용량 투여(durvalumab 20 mg/kg 및 tremelimumab 1 mg/kg Q4W). 체중이 다시 30kg 이상으로 회복되면 환자는 durvalumab 1500 mg 및 tremelimumab 75 mg Q4W의 고정용량 투여를 시작한다.)
2. 수술(Surgery) 
원발 종양 병변의 위치에 따라, D2 림프절 절제를 동반한 전체위절제술(TG) 또는 원위부위절제술(DG)을 시행할 것이다.
3. 수술 후 보조요법(adjuvant) 치료 
수술 4~6주 후, 수술 후 보조요법으로서 12개월 동안 매4주 durvalumab 1500 mg을 D1에 투여할 것이다. (주: 환자의 체중이 30kg 이하가 되면, 시험자와 시험 담당 의사 간 협의 후 체중기준용량 투여(durvalumab 20 mg/kg Q4W). 체중이 다시 30kg 이상으로 회복되면 환자는 durvalumab 1500 mg Q4W의 고정용량 투여를 시작한다.)

IVIG IV infusion (not experimental) followed by ART5803 IV infusion (experimental)

A monovalent (one-armed) antibody, that binds to the NTD of the NMDAR NR1 subunit without causing NMDAR inhibition, activation, or receptor internalization, while simultaneously blocking the ability of the pathogenic anti-NMDAR autoantibodies to bind to the receptor.

ART5803

Administered as background treatment prior to the investigational product

Intravenous immunoglobulin (IVIG)

Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive QL1706, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 or QL1706 combined with pemetrexed.

QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.

Participants with locally advanced or metastatic NSCLC patients who are PD-L1 negative will receive tiselizumab, paclitaxel/pemetrexed and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with tiselizumab or tiselizumab combined with pemetrexed.

Tilesizumab will be administered by IV infusion at 200mg on Day 1 of each 21-day cycle until unacceptabletoxicity or loss of clinical benefit.

Tilesizumab

Along with standard of care neoadjuvant chemotherapy treatments and procedures, participants will receive oral 50,000 international units of Vitamin D3 supplementation at the initiation of chemotherapy once a week.

Participants will receive standard of care neoadjuvant chemotherapy with doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) for 4 cycles and paclitaxel (80 mg/m2) weekly for 12 cycles. Doxorubicin and cyclophosphamide (AC) may be administered on a classical every 3 week or dose dense every 2-week (with growth factor support) schedule at the treating physician's discretion. Routine incorporation of carboplatin is not required, however use of carboplatin (AUC 1.5 to 2 weekly or AUC 6 on week 1, 4, 7, and 10) with paclitaxel is allowed at the treating investigator's discretion.

Upon completion of neoadjuvant chemotherapy, all patients will undergo definitive surgery with either breast conservation or mastectomy with axillary lymph node staging. Type of surgery will be determined by the treating physician.

Standard of Care Neoadjuvant Chemotherapy (NAC)

Participants with deficient levels of vitamin D will receive vitamin D supplementation at the initiation of chemotherapy with 50,000 IU of oral vitamin D3 (cholecalciferol) once a week to be continued for 20 weeks during neoadjuvant chemotherapy.

Vitamin D3

Participants that will receive Vitamin D will be asked to fill out a drug diary on a daily basis. Compliance and feasibility will be assessed through a drug diary and pill counts at set time points.

Drug Diary

Standard of care neoadjuvant chemotherapy

Study Nurse

Emily H Douglas, MD

Up to 12 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC

Injection of 2 mCi of 89Zr-DFO-SC16.56 for Phase I participants. Dose for Phase II will be determined by results from Phase I.

89Zr-DFO-SC16.56

SC16.56, Phase I, Cohort 2

SC16.56, Phase I, Cohort 3

Up to 18 participants with tumors that are found to be \>/= 50% positive for DLL3 by IHC

Dose for Phase II will be determined by results from Phase I.

OSI-906, 에를로티닙, 위약

실험: OTL-203, 활성 비교자: Allo-HSCT

젬시타빈, N-803, M-CENK

SAR441344, 위약

NTI164, 위약

ONC-392 낮음, ONC-392 높음, 루테튬 Lu 177 vipivotide tetraxetan

세바셈텐 1회 복용량, 세바셈텐 2회 복용량, 세바셈텐 3회 복용량, 위약

폴피리녹스, 옥살리플라틴, 류코보린, 이리노테칸, 5-플루오로우라실(5-FU), NIS793, 화학방사선요법, 카페시타빈, 방사선 치료, 수술

ZG006, ZG005

AZD5363, AZD5363, AZD5363, AZD5363

피하(SC) ABBV-383, 정맥(IV) ABBV-383

FOLFOX4, Adebrelimab, Apatinib, Icaritin, SHR-1701, QL1706, Bevacizumab, HAIC, 국소 치료, 원래 치료 요법

ALLO-316, ALLO-647, 플루다라빈, 사이클로포스파마이드

JDB153, 펜풀리맙

BGP-014, 위약

근치적 절제수술이 가능한 MMR proficient 위 또는 위식도접합부 선암 환자에서 수술 전 보조항암요법 durvalumab(MEDI4736)/docetaxel/oxaliplatin/S-1 + 수술 + 수술 후 보조항암화학요법 durvalumab/S-1 치료의 임상시험

ART5803, 정맥 주사 면역글로불린(IVIG)

QL1706, 타일레시주맙

표준 치료 신보조 화학 요법(NAC), 비타민 D3, 약물 일지

89Zr-DFO-SC16.56, SC16.56, 1상, 코호트 2, SC16.56, 1상, 코호트 3, SC16.56, 2상