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

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

Participants receive VX15/2503 (pepinemab) IV over 60 minutes and nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

Nivolumab

VX15/2503

Surgery

Participants receive VX15/2503 (pepinemab) IV over 60 minutes and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.

Ipilimumab

Participants receive VX15/2503 (pepinemab) IV over 60 minutes, nivolumab IV over 30 minutes, and ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.

Participants receive nivolumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.

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.

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.

A phase 1/2 dose escalation and cohort expansion study of LP-184 in patients with advanced or metastatic solid tumors. A BOIN design will be used to evaluate the safety of LP-184, determine the MTD, and identify the RP2D. Patients who meet all eligibility criteria will be enrolled to receive treatment with LP-184 at a dose determined based on the available cohort at the time of each patient's enrollment. Patients will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles.

LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage.

LP-184

Phase 1b/2 Expansion cohort of participants with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma (PDAC) or other solid tumours with known DDR genomic alterations to determine the optimal dose/RP2D and to obtain preliminary estimates of clinical activity.

Phase 1b/2 Expansion cohort of participants with Hormone Receptor (HR)-Negative and HER2-Negative Breast Cancer (TNBC) to evaluate the safety, tolerability and clinical activity of LP-184 in combination with olaparib

A poly (ADP-ribose) polymerase (PARP) inhibitor that impairs homologous recombination (HR) dependent DNA damage repair by trapping PARP1/2 on DNA, leading to synthetic lethality in BRCA1/2-deficient cells.

Olaparib

Phase 1b/2 Expansion cohort of participants with KEAP1 and/or STK11-mutated and programmed cell death ligand-1 (PD-L1)-low NSCLC to evaluate the safety, tolerability and clinical activity of LP-184 in combination with nivolumab and ipilimumab in .

Nivolumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the PD-1 receptor on the surface of T cells, Nivolumab restores immune cells' ability to recognize and attack cancer cells.

Ipilimumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the CTLA4 protein on the surface of T cells, Ipilimumab activates T-cells and allows T-cells to attack cancer cells.

Nivolumab & Ipilimumab

Sevasemten is administered orally once per day

Sevasemten Dose 1

Placebo is administered orally once per day

Sevasemten Dose 2

Sevasemten Dose 3

Participants receive oral DLBS1033 as adjuvant therapy in addition to standard therapy for diabetic polyneuropathy.

Intervention Drug: DLBS1033 Dose: 980 mg orally, three times daily Duration: 28 days Description: DLBS1033 contains lumbrokinase (Lumbricus low-molecular-weight proteins) with anti-inflammatory, fibrinolytic, and neuroregenerative activity.

Other Components: Standard therapy for diabetic polyneuropathy (per treating physician).

Intervention Drug: DLBS1033 Dose: 980 mg orally, three times daily Duration: 28 days

Description: DLBS1033 contains lumbrokinase (Lumbricus low-molecular-weight proteins) with anti-inflammatory, fibrinolytic, and neuroregenerative activity.

Other Components: Standard therapy for diabetic polyneuropathy (per treating physician).

DLBS1033

Participants receive placebo capsules identical in appearance to DLBS1033, in addition to standard therapy.

Intervention Drug: Placebo Dose: Matching placebo, orally, three times daily Duration: 28 days

Other Components: Standard therapy for diabetic polyneuropathy (per treating physician).

Placebo Comparator: Placebo + Standard Therapy

Participants receive placebo capsules identical in appearance to DLBS1033, in addition to standard therapy.

Intervention Drug: Placebo Dose: Matching placebo, orally, three times daily Duration: 28 days Other Components: Standard therapy for diabetic polyneuropathy (per treating physician).

Krisandi Hartanto, MD

Escalating doses of VS-6766 (RO5126766) and Defactinib (VS-6063) were evaluated in patients with advanced solid tumours to establish the recommended phase II dose. Dose escalation followed a 3+3 design with a maximum of four patient cohorts.

This arm is now complete.

VS-6766 will be supplied as 0.8mg hypromellose (HPMC) capsules for oral administration. The capsule fill consists of VS-6766 and the inactive ingredients mannitol and magnesium stearate.

VS-6766 will be administered on a twice weekly (Monday and Thursday or Tuesday and Friday) schedule for 3 weeks followed by 1 week off in every 4 week cycle, under fasting conditions (approximately 1 hour prior or 2 hours after a meal). The starting dose, based on the previous Phase I trial will be 3.2 mg given orally as a single daily dose. This can be escalated to a maximum of 4mg (as per dose escalation rules in the protocol).

VS-6766

Defactinib is formulated as a white to off-white oval tablet for oral administration and supplied in single unit dose strength of 200 mg in 120 cc (HDPE) bottles. In addition to Defactinib, formulation components include microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate.

Patients will receive Defactinib orally immediately after a meal twice daily (approximately every 12 hours) for 3 weeks followed by 1 week off in every 4 week cycle. The starting dose will be 200mg. This can be escalated to a maximum of 400mg (as per dose escalation rules in the protocol).

Defactinib

The dose expansion phase will evaluate the recommended phase II dose of the combination of VS-6766 (RO5126766) and Defactinib (VS-6063), as decided in the dose escalation phase in patients with KRAS mutant NSCLC (20 patients).

This arm is now complete.

The dose expansion phase will evaluate the recommended phase II dose of the combination of VS-6766 (RO5126766) and Defactinib (VS-6063), as decided in the dose escalation phase in patients advanced RAS mutant solid tumours with biopsiable disease (6 patients).

This arm is now complete.

The dose expansion phase will evaluate the recommended phase II dose of the combination of VS-6766 (RO5126766) and Defactinib (VS-6063), as decided in the dose escalation phase in patients with LGSOC (20 patients).

The dose expansion phase will evaluate the recommended phase II dose of the combination of VS-6766 (RO5126766) and Defactinib (VS-6063), as decided in the dose escalation phase in patients with CRC (10 patients).

This arm is now complete.

The dose expansion phase will evaluate the recommended phase II dose of the combination of VS-6766 (RO5126766) and Defactinib (VS-6063), as decided in the dose escalation phase in patients with KRAS G12V mutant NSCLC (10 patients).

The dose expansion phase will evaluate the recommended phase II dose of the combination of VS-6766 (RO5126766) and Defactinib (VS-6063), as decided in the dose escalation phase in patients with RAS/RAF mutant endometrioid subtype of gynaecological cancers (ovarian, endometrial, endometriosis-related) (10 patients).

The dose expansion phase will evaluate the recommended phase II dose of the combination of VS-6766 (RO5126766) and Defactinib (VS-6063), as decided in the dose escalation phase in patients with pancreatic cancer (10 patients).

Institute of Cancer Research, United Kingdom

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

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

Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

MCI-196

Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Placebo of Simvastatin

Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Placebo of MCI-196

Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Simvastatin

Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

AZD1163

Participants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Participants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Participants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.

Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

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.

MIB-626 tablets will be provided at dose strength of 500mg. Three doses will be studied in ascending order: 500 mg (one tablet) once daily; 1000 mg (two 500 mg tablets once daily) or 1000 mg (two 500 mg tablets) twice daily.

MIB-626

Matching placebo tablets (number and frequency of tablets will match the active intervention group at each of the three doses)

Brian Skotko, MD, MPP

Nancy Latham, PhD

Shalender Bhasin, MB, BS

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

Patients receive ZEN003694 PO QD on days 1-21, nab-paclitaxel IV over 30 minutes on day 1, 8, and 15, and pembrolizumab IV over 30 minutes every 21 days of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity with a maximum of 35 doses of pembrolizumab administered. Patients also undergo CT or MRI scan and collection of blood samples throughout the trial.

BET Bromodomain Inhibitor ZEN-3694

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Nab-paclitaxel

Pembrolizumab

Patients receive ZEN003694 PO QD on days 1-7 prior to combination therapy. Patients then receive ZEN003694 PO QD on days 1-21, nab-paclitaxel IV over 30 minutes on days 1, 8, and 15, and pembrolizumab IV over 30 minutes every 21 days of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity with a maximum of 35 doses of pembrolizumab administered. Patients also undergo biopsies on study, and CT or MRI scans and collection of blood samples throughout the trial.

Biopsy Procedure

Site Public Contact

Jose J. Acevedo Mejia

Ana C. Garrido-Castro

Nancy Chan

Kai C. Johnson

Vandana G. Abramson

Short-course radiotherapy and 4 cycles of mFOLFOX6 followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)

short-course radiotherapy

Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours

mFOLFOX6

TME surgery

Conventional chemoradiotherapy followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)

45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)

Chemoradiotherapy

For prospective cohort, an additional follow-up at D14 and M1 will be carried out.

A blood test and urinary test will be performed at D14.

Follow-up at D14

A blood test and urinary test will be performed at M1.

OSI-906, 에를로티닙, 위약

젬시타빈, N-803, M-CENK

SAR441344, 위약

이필리무맙, 니볼루맙, VX15/2503, 수술

근골격계 질환의 염증 바이오마커로서의 새로운 PET 방사성 리간드

N-803, ETBX-071, M-CENK

LP-184, 올라파리브, 니볼루맙 및 이필리무맙

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

DLBS1033, 위약 비교군: 위약 + 표준 치료

VS-6766, 데팍티닙

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

MCI-196, 심바스타틴 위약, 심바스타틴, MCI-196 위약

AZD1163, 위약

AZD5363, AZD5363, AZD5363, AZD5363

MIB-626, 위약

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

ALLO-316, ALLO-647, 플루다라빈, 사이클로포스파마이드

BET 브로모도메인 억제제 ZEN-3694, 생검 절차, 생체 시료 채취, 컴퓨터 단층 촬영, 자기 공명 영상, 나브-파클리탁셀, 펨브롤리주맙

단기 방사선 치료, mFOLFOX6, 화학방사선 요법, TME 수술

D14 후속 검사, M1 후속 검사