위암 환자를 대상으로 기존 항암제와 새로운 항체를 함께 사용해 치료 효과를 살펴보는 임상시험입니다.

TST001 + Pembrolizumab + Chemotherapy (FOLFOX6 or CapOx)

Placebo will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.

Pembrolizumab and either Capcecitabine + Oxaliplatin or Oxaliplatin+Leucovorin + 5-fluorouracil

Placebo + Pembrolizumab + Chemotherapy (FOLFOX6 or CapOx)

TST001 will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.

TST001 + 펨브롤리주맙 + 화학요법(FOLFOX6 또는 CapOx)

펨브롤리주맙과 캡세시타빈 + 옥살리플라틴 또는 옥살리플라틴 + 류코보린 + 5-플루오로우라실 병용 요법

위약 + 펨브롤리주맙 + 화학요법(FOLFOX6 또는 CapOx)

진행성 또는 전이성 위암/위식도접합부 선암의 1차 치료로서 오세미타맙(TST001), 펨브롤리주맙 및 화학요법 병용 요법

망막 질환을 가진 환자에게 주사한 치료제의 장기 안전성과 효과를 비교하는 시험입니다.

Participants previously treated with sub-retinal injection of BIIB111 in antecedent studies 273CH301 (NCT03496012) and 273CH203 (NCT03507686) will be enrolled. Participants previously treated with this same sub-retinal injection (rAAV2-REP1) in antecedent studies 20150371 (NCT02553135), Pro00028599 (NCT02077361), THOR-TUE-01 (NCT02671539), CHM09/01 (NCT01461213) and REGEN2015 (NCT02407678) will also be invited for enrollment. This is a follow-up study, investigational product was administered in the previous study.

Administered as specified in the treatment arm.

BIIB111

Participants previously treated with sub-retinal injection of BIIB112 in the antecedent study 274RP101 (NCT03116113) will be enrolled. This is a follow-up study, investigational product was administered in the previous study.

BIIB112

Untreated participants who served as controls in the antecedent study 273CH301 (NCT03496012), investigating treatment with BIIB111, will be enrolled. This is a follow-up study, participants will not be administered study medication nor receive a sham surgery.

선행 연구 273CH301(NCT03496012) 및 273CH203(NCT03507686)에서 BIIB111의 망막하 주사 치료를 받은 참가자가 등록될 예정입니다. 선행 연구 20150371(NCT02553135), Pro00028599(NCT02077361), THOR-TUE-01(NCT02671539), CHM09/01(NCT01461213) 및 REGEN2015(NCT02407678)에서 동일한 망막하 주사(rAAV2-REP1) 치료를 받은 참가자도 등록될 예정입니다. 본 연구는 후속 연구이며, 연구용 의약품은 이전 연구에서 투여되었습니다.

선행 연구 274RP101(NCT03116113)에서 BIIB112의 망막하 주사 치료를 받은 참가자가 등록될 예정입니다. 본 연구는 후속 연구이며, 연구용 의약품은 이전 연구에서 투여되었습니다.

BIIB111 치료를 조사하는 선행 연구 273CH301(NCT03496012)에서 대조군으로 참여했던 미치료 참여자가 등록될 예정입니다. 본 연구는 추적 연구이며, 참여자에게는 연구 약물이 투여되지 않으며, 가짜 수술도 시행되지 않습니다.

맥락막변성증 치료를 위한 BIIB111과 X연관성 색소성 망막염 치료를 위한 BIIB112의 장기 안전성 및 효능 추적 조사

ALS 환자 12명을 대상으로 QRL-101 단일 용량의 안전성과 체내 반응을 보는 초기 시험입니다.

Single doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.

QRL-101

Single doses of comparator placebo will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.

Single doses of compartor placebo will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.

Placebo

QRL-101은 단회 투여되며, 경구 투여됩니다. 투여량은 비임상, 임상, 안전성 및 약동학(PK) 자료에 따라 변경될 수 있습니다.

비교 대상 위약은 단회 투여됩니다. 투여량은 비임상, 임상, 안전성 및 약동학(PK) 자료에 따라 변경될 수 있습니다.

위약

ALS 성인 환자에서 QRL-101의 PK/PD 관계를 탐구하는 연구

SOC + TSC-100

SOC + TSC-101

Control

Monzr M Al Malki, MD

Iris Isufi, MD

Hugo Fernandez, MD

Melholm Sohl, MD

Tania Jain, MD

Yi-Bin Chen, MD

Joseph Uberti, MD

Hyung Suh, MD

Ran Reshef, MD

Alla Keyzner, MD

Anson Snow, MD

Saar Gill, MD

Luis Pineiro, MD

Uday Popat, MD

Sameem Abedin, MD

Camrelizumab

Apatinib

S-1, Oxaliplatin

Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.

IMGN151

Carboplatin

Participants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle.

Olaparib

Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.

Bevacizumab

Participants will receive IMGN151 Day 1 of a 21-day cycle.

TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.

TOL-3021

TOL-3021 Placebo

Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 1) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit.

A sleep extension algorithm (algorithm 1) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.

Algorithm 1

Subjects randomized into Group 2 will be provided with a sleep schedule each week based on an algorithm (Algorithm 2) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit.

A sleep extension algorithm (algorithm 2) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.

Algorithm 2

Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 3) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit.

A sleep extension algorithm (algorithm 3) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.

Algorithm 3

류머티즘 관절염 및 염증성 근육병증 환자와 건강한 참가자를 대상으로 염증 이미지를 개선하는 신약의 효과를 보는 시험입니다.

Healthy participants receive about 10 mCi of \[11C\]MC1 intravenously followed by a whole body PET/CT scan. If radiation dose to selected body organs is within safety limit, Phase 2 of study was initiated

PET radioligand for Cyclooxygenase-2 (COX-2)

11C-MC1

Positron Emission Tomography (PET)/computed tomography (CT) Scan

Participants with rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM), or axial spondyloarthritis (AXSPA), had a baseline whole body PET/CT scan after about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.

Celecoxib

Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.

Radioligand for 18-kDa Translocator Protein

[11C]ER176

Healthy participants had a baseline brain PET/CT scan after receiving about 20 mCi \[11C\]MC1 followed by a second brain PET/CT scan with 20 mCi \[11C\]MC1 intravenously after blockade with single dose of celecoxib 600 mg orally on same day. Participants had arterial blood sampling with each brain scan.

건강한 참가자들은 약 10 mCi의 [11C]MC1을 정맥 주사받은 후 전신 PET/CT 스캔을 받았습니다. 선택된 신체 장기에 대한 방사선량이 안전 한도 내에 있으면 2상 연구가 시작되었습니다.

양전자 방출 단층 촬영(PET)/컴퓨터 단층 촬영(CT) 스캔

류마티스 관절염(RA), 특발성 염증성 근병증(IIM) 또는 축성 척추관절염(AXSPA)이 있는 참가자는 약 15mCi의 [11C]MC1을 투여한 후 기저 전신 PET/CT 스캔을 받았고, 같은 날 200-400mg의 셀레콕시브를 단회 경구 투여하여 차단한 후 약 15mCi의 [11C]MC1을 정맥 주사하여 두 번째 전신 PET/CT 스캔을 받았습니다.

셀레콕시브

건강한 참가자들은 약 15 mCi의 [11C]MC1을 투여받은 후 기저 전신 PET/CT 스캔을 시행하였고, 같은 날 셀레콕시브 200-400 mg을 단회 경구 투여하여 차단한 후 약 15 mCi의 [11C]MC1을 정맥 주사하여 두 번째 전신 PET/CT 스캔을 시행하였다. 두 번째 방문에서 참가자들은 약 15 mCi의 [11C]ER176을 투여받은 후 기저 전신 PET/CT 스캔을 시행하였고, 같은 날 셀레콕시브 200-400 mg을 단회 경구 투여하여 차단한 후 약 15 mCi의 [11C]ER176을 정맥 주사하여 두 번째 전신 PET/CT 스캔을 시행하였다.

건강한 참가자들은 약 20 mCi의 [11C]MC1을 투여받은 후 기준 뇌 PET/CT 스캔을 받았고, 같은 날 셀레콕시브 600mg을 단회 경구 투여하여 차단한 후 20 mCi의 [11C]MC1을 정맥 주사하여 두 번째 뇌 PET/CT 스캔을 받았습니다. 참가자들은 각 뇌 스캔 시 동맥혈 샘플을 채취했습니다.

National Institute of Mental Health (NIMH)

근골격계 질환의 염증 바이오마커로서의 새로운 PET 방사성 리간드

The experimental arm of this study is the treatment group receiving the combination of pre- and post-surgery immunotherapy with N-803, ETBX-071, and M-CENK in addition to surgery.

A subcutaneous injection of an IL-15 superagonist.

N-803

A subcutaneous injection of a prostate-specific antigen (PSA) adenovirus vaccine.

ETBX-071

An intravenous infusion of the patient's own NK cells that have been expanded and activated in a laboratory.

M-CENK

Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks

LTP001, 6 mg, was administered orally once daily in the morning

LTP001

Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks

Placebo to LTP001 was administered once daily in the morning

Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.

TTI-101

Participants will receive 800 mg/day of TTI-101 BID for 12 weeks.

Participants will receive a matching placebo BID for 12 weeks.

Sevasemten is administered orally once per day

Sevasemten Dose 1

Placebo is administered orally once per day

Sevasemten Dose 2

Sevasemten Dose 3

Systemic SHR-A1811 therapy combined with intrathecal SHR-A1811 therapy

Systemic therapy: 4.8 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.

SHR-A1811

Intrathecal therapy: Administered intrathecally on Day 1 of each cycle. Dose escalation follows a Bayesian Optimal Interval (BOIN) design with three predefined dose levels-15 mg, 30 mg, and 40 mg. The starting dose level is 15 mg. Patients are enrolled in cohorts of three per dose level. If no dose-limiting toxicities (DLTs) are observed, escalation proceeds to the next higher dose level according to the BOIN algorithm. Treatment is administered for a minimum of two cycles and is continued until cerebrospinal fluid (CSF) cytology achieves negative conversion, completion of six cycles, or intolerable adverse events, whichever occurs first. Extension beyond six cycles may be permitted following investigator's discussion and must be documented with justification.

Systemic SHR-A1811 therapy combined with radiotherapy

radiotherapy is determined by investigator's choice

radiotherapy

Peking University Cancer Hospital & Institute

CC-95251

Azacitidine

Venetoclax

Cisplatin/capecitabine or cisplatin/5-fluorouracil

Cisplatin

5-fluorouracil or Capecitabine

gastrectomy

Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab

Trastuzumab

cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab

Pertuzumab

European Organisation for Research and Treatment of Cancer - EORTC

Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules

Palbociclib 100mg

Fulvestrant or Tamoxifen or Aromatase Inhibitor

Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules

Palbociclib 125mg

Ramucirumab will be administered intravenously prior to intravenously adminstration of SAR408701 every two 2 weeks.

Pharmaceutical form:concentrate for solution for injection Route of administration: intravenous infusion

SAR408701

Pharmaceutical form: concentrate for solution for injection Route of administration: intravenous infusion

ramucirumab

Participants will be treated with tusamitamab ravtansine and ramucirumab and pembrolizumab to assess the tolerability of the combination

pembrolizumab

Preoperative chemotherapy using Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) as a single agent performed 45 days before surgery：Cabazitaxel 25 mg/m2, Docetaxel 35 mg/m2, Mitoxantrone 4 mg/m2 or Satraplatin 80 mg/m2, through intravenous (IV) or oral (Satraplatin) administration. IV or oral administration once every 7 days, totally 4 cycles. There is a 17-day interval between the last dose and surgery.

Procedure: radical prostatectomy surgery.

As preoperative neoadjuvant chemotherapy, drugss including Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) will be administered as a single agent performed 45 days before surgery：Cabazitaxel 25 mg/m2, Docetaxel 35 mg/m2, Mitoxantrone 4 mg/m2 or Satraplatin 80 mg/m2, through intravenous (IV) or oral (Satraplatin) administration. IV or oral administration once every 7 days, totally 4 cycles. There is a 17-day interval between the last dose and surgery.

Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin

No neoadjuvant chemotherapy using CDMS will be done for patients who are diagnosed with localized prostate cancer but subject to direct surgery to radically remove the primary tumor.

Shanghai Jiao Tong University School of Medicine

All participant patients should be male, adult.

Jiannan Chen, Ph.D

Qilai Long, Ph.D

In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 monotherapy at various doses every 3 weeks to determine MTD/RP2D(s).

In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received one and no more than three lines of prior systemic therapy in the advanced metastatic setting will be randomized to one of two doses of EO-3021 dosed every 3 weeks to confirm RP2D.

Anti-Claudin 18.2 antibody drug conjugate

EO-3021

In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s).

In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received only one prior systemic therapy in the advanced metastatic setting will be treated with EO-3021 in combination with ramucirumab every 3 weeks to confirm RP2D.

Ramucirumab (CYRAMZA®)

In escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s).

In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have not received any prior systemic therapies in the advanced metastatic setting will be treated with EO-3021 in combination with dostarlimab every 3 weeks to confirm RP2D.

진행성 또는 전이성 위암/위식도접합부 선암의 1차 치료로서 오세미타맙(TST001), 펨브롤리주맙 및 화학요법 병용 요법

맥락막변성증 치료를 위한 BIIB111과 X연관성 색소성 망막염 치료를 위한 BIIB112의 장기 안전성 및 효능 추적 조사

ALS 성인 환자에서 QRL-101의 PK/PD 관계를 탐구하는 연구

SOC + TSC-100, SOC + TSC-101, 대조군

캄렐리주맙, 아파티닙, S-1, 옥살리플라틴

IMGN151, 카보플라틴, 베바시주맙, 올라파립

TOL-3021, TOL-3021 위약

알고리즘 1, 알고리즘 2, 알고리즘 3

근골격계 질환의 염증 바이오마커로서의 새로운 PET 방사성 리간드

N-803, ETBX-071, M-CENK

LTP001, 위약

TTI-101, 위약

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

SHR-A1811, SHR-A1811, 방사선 치료

CC-95251, 아자시티딘, 베네토클락스

시스플라틴, 5-플루오로우라실 또는 카페시타빈, 트라스투주맙, 페르투주맙, 위절제술

팔보시클립 100mg, 팔보시클립 125mg, 풀베스트란트 또는 타목시펜 또는 아로마타제 억제제

SAR408701, 라무시루맙, 펨브롤리주맙

카바지탁셀, 도세탁셀, 미톡산트론 또는 사트라플라틴

EO-3021, 라무시루맙(CYRAMZA®), 도스타리맙