Accruing Trials
A Study of (225Ac)-FPI-2059 in Adult Participants With Solid Tumours
ClinicalTrials.gov ID NCT05605522
Sponsor Fusion Pharmaceuticals Inc.
Local PI Rebecca Wong
Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Squamous Cell Carcinoma of Head and Neck
- Colorectal Cancer
- Gastric Cancer
This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of [225Ac]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.
The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of [225Ac]-FPI-2059 administered intravenously every 56 days.
After the RP2D for [225Ac]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.
Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (ACTION-1)
ClinicalTrials.gov ID NCT05477576
Sponsor RayzeBio, Inc.
Local PI Rebecca Wong
Conditions
- GEP-NET
- Gastroenteropancreatic Neuroendocrine Tumor
- Gastroenteropancreatic Neuroendocrine Tumor Disease
- Neuroendocrine Tumors
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.
(Ac-225)-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (ACCEL)
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (PSMACare)
ClinicalTrials.gov ID NCT05849298
Sponsor Novartis Pharmaceuticals
Local PI Robert Hamilton
Conditions
- Prostatic Neoplasm
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium [177Lu] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans). Approximately 120 participants will be randomized.
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PSMA-DC)
ClinicalTrials.gov ID NCT05939414
Sponsor Novartis Pharmaceuticals
Local PI Andrew McPartlin
Conditions
- Oligometastatic Prostate Cancer (OMPC)
All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium (68Ga) gozetotide (also known as [68Ga]Ga-PSMA-11) or piflufolastat (18F) ( also known as[18F]DCFPyL) PET/CT scan and conventional imaging (i.e., CT/MRI and bone scans).
Piflufolastat (18F) PET/CT scan will be performed in countries where it is approved.
Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic Prostate Cancer (PC) lesions after randomization and before the start of treatment with AAA617 or observation.
The duration of SBRT procedures is approximately 3 weeks.
For participants randomized to the investigational arm (AAA617), the treatment duration will be up to 4 cycles of AAA617. For participants randomized to the control arm (observation) the treatment duration will end at the last fraction of SBRT administration.
The visit frequency will be every week 1 and 3 of each of the 4 cycles and every 16 weeks thereafter (for both arms) until first event of disease progression (RECIST 1.1)
The study duration is approximately 6.5 years.
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
ClinicalTrials.gov ID NCT04333537
Sponsor NRG Oncology
Local PI John de Almeida
Conditions:
- Buccal Mucosa Squamous Cell Carcinoma
- Floor of Mouth Squamous Cell Carcinoma
- Gingival Squamous Cell Carcinoma
- Hard Palate Squamous Cell Carcinoma
- Lip Squamous Cell Carcinoma
- Lower Alveolar Ridge Squamous Cell Carcinoma
- Oral Cavity Squamous Cell Carcinoma
- Retromolar Trigone Squamous Cell Carcinoma
- Stage I Lip and Oral Cavity Cancer AJCC v8
- Stage II Lip and Oral Cavity Cancer AJCC v8
- Tongue Squamous Cell Carcinoma
- Upper Alveolar Ridge Squamous Cell Carcinoma
PRIMARY OBJECTIVES:
I. To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). (Phase II) II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) III. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III)
SECONDARY OBJECTIVES:
I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
II. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms.
IV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:
IVa. Neck Dissection Impairment Index (NDII). IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH). IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
VII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. IX. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.
EXPLORATORY OBJECTIVES:
I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between surgical arms.
II. To collect biospecimens for future translational science studies. III. To assess the DFS between arms in low-risk patients.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy.
GROUP II: Patients undergo standard END.
After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.
SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer (SELECT)
ClinicalTrials.gov ID NCT05451004
Sponsor Canadian Cancer Trials Group
Local PI John de Almeida
Conditions:
-
Oropharyngeal Cancer
This study is being done to answer the following question:
Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?
Finished Accrual
Study Evaluating mCRPC Treatment Using PSMA [Lu-177)-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)
ClinicalTrials.gov ID NCT04647526
Sponsor POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Local PI Di Maria Jiang
Conditions
- Metastatic Castration-Resistant Prostate Cancer
The primary objective of the study is to determine the efficacy of [Lu-177]-PNT2002 ([Lu-177]-PSMA-I&T) versus abiraterone or enzalutamide in delaying radiographic progression in patients with mCRPC.
The study consists of 3 phases: Dosimetry, Randomized Treatment, and Long term Follow up.
The study will commence with a 25-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment phase in approximately 390 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either [Lu-177]-PNT2002 (Arm A), or enzalutamide or abiraterone (Arm B). Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility, may crossover to receive [Lu-177]-PNT2002. All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3).
Only patients that meet PSMA PET avidity criteria per central review will be eligible for this study.
Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
ClinicalTrials.gov ID NCT02743741
Sponsor University Health Network, Toronto
Local PI Rebecca Wong
Conditions:
- Neuroendocrine Tumors
This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
A Phase II Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Prostate specific membrane antigen (PSMA)-avid Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone (ARROW)
177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer
ClinicalTrials.gov ID NCT04663997
Sponsor Canadian Cancer Trials Group
Local PI Aaron Hansen & Di Maria Jiang
Conditions:
- Prostate Cancer
The standard or usual treatment for this disease is a chemotherapy drug called docetaxel, given by intravenous every 3 weeks, for up to 12 treatments.
177Lu-PSMA-617 is a new type of therapy for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. 177Lu-PSMA-617 has been shown to shrink tumours in animals and has been studied in limited numbers of men with prostate cancer and seems promising but it is not clear if it can offer better control of prostate cancer compared to docetaxel chemotherapy .
A Phase 1/ 2 Study of (225Ac)-FPI-1434 Injection
ClinicalTrials.gov ID NCT03746431
Sponsor Fusion Pharmaceuticals Inc.
Local PI Ale Berlin
Conditions:
- Advanced Solid Tumours
- Endometrial Cancer
- Cervical Cancer
- Ovarian Cancer
- Breast Cancer
- Triple Negative Breast Cancer (TNBC)
- HER2-negative Breast Cancer
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Adrenocortical Carcinoma
- Uveal Melanoma
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of [225Ac]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of [111In]-FPI-1547 (radioimmuno-imaging agent), and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of [225Ac]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of [111In]-FPI-1547 (radioimmuno-imaging agent).
Completed Trials
A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/ Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer
ClinicalTrials.gov ID NCT04467515
Sponsor Precirix
Local PI Rebecca Wong
Conditions
- Advanced/Metastatic HER2-positive Breast
- Gastric
- Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients with progressive, advanced/metastatic HER2-positive breast, gastric, and GEJ cancer with disease progression following anti-HER2 standard of care treatment. The study duration for each phase will be up to 18 months. The study is comprised of a Treatment Period, consisting of a maximum of 4 cycles (12 weeks per cycle) of study drug, and a 12-month Long-Term Follow-Up Period.
A Phase 1/ 2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)
ClinicalTrials.gov ID NCT01796171
Sponsor Nordic Nanovector
Local PI Richard Tsang
Conditions:
- Non-Hodgkin Lymphoma
- Follicular Lymphoma
Part A of the study was a Phase 1/2a study to assess the safety and preliminary efficacy of different treatment regimens of Betalutin with expansion at the candidate recommended Phase 2 doses. Part B was a dedicated Phase 2b randomized substudy to further assess the efficacy and safety of the candidate recommended Phase II doses. Part C was a Phase 2a fixed dose expansion cohort planned to obtain supplementary pharmacokinetic data.
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA)
ClinicalTrials.gov ID NCT02665065
Sponsor Actinium Pharmaceuticals
Local PI Arjun Datt Law
Conditions
- Acute Myeloid Leukemia
- Leukemia, Acute Myeloid
- Myeloid Leukemia, Acute
- Leukemia, Myeloid, Acute
SIERRA is a pivotal Phase 3 randomized controlled study of Iomab-B in Relapsed or Refractory AML patients. The SIERRA trial has a primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival following randomization to Iomab-B, as well as Event-Free Survival. Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning.