Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

he radiation dose is about 2-7 mCi for a single patient.Using a syringe to withdraw 68Ga-NYM005 injection, the dose will be administered via an intravenous injection and the injection time will be about 45-60 seconds.

68Ga-NYM005 injection

Chunjing Yu

68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma

Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients

Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM005 Injection Prepared by Kit for the Preparation of the 68Ga-NYM005 Injection in Patients With Metastatic Clear Cell Renal Carcinoma.

Norroy Bioscience Co., LTD

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Lung Neoplasms

Triple Negative Breast Neoplasms

Head and Neck Neoplasms

Mesothelioma

Mesothelioma, Malignant

Breast Diseases

Skin Diseases

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Malignant Mesothelioma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Humanized monoclonal antibody to human carbonic anhydrase IX

CA9hu-1

Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. CA IX is not expressed in normal tissue, potentially providing a cancer-associated target that would not likely result in significant interruption of normal biologic function in organs not affected by cancer. A humanized monoclonal antibody CA9hu-1 has shown robust activity in a variety of tumour models including models of ovarian, prostate, breast, pancreatic, colon and lung where tumour growth and metastasis are inhibited when CA9hu-1 is used as a monotherapy. Enhancement of chemotherapy has also been demonstrated in several models in combination with CA9hu-1. CA IX is also expressed by tumour-associated cells (angiogenic endothelium, tumour-associated macrophages), which also drive cancer progression. Thus, targeting CA IX with CA9hu-1 in cancer patients is expected to affect multiple pathways and multiple tumour compartments that are important to tumour progression. Taken together, there is strong rationale for developing hu-CA91 for the treatment of advanced cancer. The present study was designed to establish safety and toxicity profile and maximum tolerated dose of CA9hu-1, evaluate pharmacokinetics, investigate the presence of anti-drug antibody, to document anti-tumour activity at a clinically relevant dose, and to document the use of \[18F\]FLT-PET as a biomarker for detection of early tumour response at a clinically relevant dose.

Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours

Phase Ib/ll Clinical Study to Evaluate Safety and Dosing of Humanised Monoclonal Antibody CA9hu-1 to Human Carbonic Anhydrase IX in Patients With Advanced Solid Tumours

The primary objective of this outcome is to establish the safety and toxicity profile of hu-CA91.

The objective of this outcome is to perform a dose escalation of of CA9hu-1 to levels of 750mg without any dose limiting toxicities.

The objective of this outcome is to determine number of patients in whom the pharmacologically active dose of CA9hu-1 wil be reached by measurement of plasma concentrations of the CA9hu-1. In order to reach the proposed pharmacologically active dose, the plasma levels of 200 +/- 100 nM are necessary.

The objective is to determine a dose at which no more than one patient out of up to six patients at the same dose level experience a highly probable or probable CA9hu-1 related dose limiting toxicity.

Measurement of CA9hu-1 half-life after human administration provides basic PK descriptive data.

The measurement of Cmax after CA9hu-1 administration will provide basic PK descriptive parameter of the drug.

The measurement of AUC after CA9hu-1 administration will provide basic PK parameter of the drug.

Analyses of plasma samples for presence of anti-drug antibodies following CA9hu-1 administration

Evaluate response (stable disease, partial response or complete response) in any of the patients as determined by the Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST).

Determination of the magnitude of change in apparent standard uptake volume (SUV) calculated from the uptake of FLT by tumour tissue quantified by \[18F\]FLT-PET during the second cycle of CA9hu-1 treatment and the relation with response

Mabpro, a.s.

Neoplasms, Multiple Primary

Antineoplastic Agents

Nivolumab

Ipilimumab

Cytoreductive nephrectomy±metastasectomy, followed by induction therapy with nivolumab plus ipilimumab combination and maintenance therapy with nivolumab.

Cytoreductive nephrectomy±metastasectomy after induction therapy with nivolumab plus ipilimumab combination, followed by maintenance therapy with nivolumab.

Induction therapy with nivolumab plus ipilimumab combination, followed by maintenance therapy with nivolumab.

Partial or complete nephrectomy by open, laparoscopic, or robotic approach and/or metastasectomy Tumor tissue, blood, urine and stool specimens for translational biomarker research will be sample at baseline, surgery, after induction therapy, and after 3 months of maintenance therapy.

Cytoreductive nephrectomy±metastasectomy

Tumor tissue, blood, urine and stool specimens for translational biomarker research will be sample at baseline, after induction therapy, and after 3 months of maintenance therapy.

Human-derived materials sampling

Won Sik Ham

Kang Su Cho

Jongchan Kim

BACKGROUND: The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) has been questioned and remains undetermined in the immuno-oncology era. Results from the two randomized trials, CARMENA and SURTIME, have questioned the role and timing of the surgery in these patients, however, these trials have only used the targeted therapy, sunitinib. With the advent of more effective systemic therapies including immune checkpoint inhibitors (ICIs), the role of surgical therapy should be reexamined.

RATIONALE: The therapeutic effects of ICIs have demonstrated improved oncological outcomes compared to sunitinib. The updated results reported the beneficial role of upfront and deferred CN approach for selected patients. No studies have formally investigated the role of CN in the immune-oncology era where combinatorial use of CN plus ICIs might be beneficial.

HYPOTHESIS: Upfront or deferred CN will improve oncological outcomes (overall survival, and progression free survival) in patients with synchronous mRCC and ≤3 IMDC risk features compared to immune checkpoint inhibitors (nivolumab plus ipilimumab combination) alone.

This is an open, randomized, multicenter comparison trial, designed to evaluate the effect of the potential role of CN in combination with immunotherapy in mRCC patients with IMDC intermediate and poor risk.

The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial

Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.

By Common Terminology Criteria for Adverse Events version 5.0

Assessed according to the Clavien-Dindo classification of surgical complications

Measured by flowcytometry at baseline and after surgery and/or after ICIs compared with OS, PFS, ORR

Measured by Next generation sequencing (NGS) methods compared with OS, PFS, and ORR

Measured by NGS methods compared with OS, PFS, and ORR

Evaluate the microbiome composition measured by NGS methods compared with OS, PFS, and ORR

Yonsei University

Micronutrients

Amino Acids

Pembrolizumab

Axitinib

Immunomodulating Agents

Selenium

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antioxidants

Protective Agents

Trace Elements

Tyrosine

Methionine

SLM only will be taken by mouth during a two-week run in period. Then patients will receive SLM and Axitinib drugs by mouth, and Pembrolizumab intravenously (IV), at the start of each 21 day cycle.

Selenium (Se) is a natural element present in the earth's crust often in association with sulfur-containing compounds. Humans get their dietary requirements mainly from food. In this study Selenium will be administered in the chemical composition of selenomethionine (SLM)

Selenomethionine (SLM)

Axitinib is a small molecule tyrosine kinase inhibitor.

Yousef Zakharia, MD

Janelle Born, RN

The purpose of this research study is to test the safety and effectiveness of Seleno-L Methionine (SLM) when combined with the standard dose and schedule of Axitinib and Pembrolizumab in patients who have locally advanced or metastatic clear cell renal cell carcinoma (ccRCC).

The proposed study is a single arm, open-label Phase I/II trial of Seleno-L Methionine (SLM) in sequential combination with the standard dose and schedule of Axitinib and Pembrolizumab in previously untreated patients with advanced ccRCC. The hypothesis is that adding SLM to the Pembrolizumab and Axitinib combination will improve efficacy without added toxicity.

This is a two-part study:

* Escalation Part 1: The study will begin with a dose-escalation study to find the maximum tolerated dose (MTD) of study drug, SLM.
* Expansion Part 2: Once the appropriate dose of SLM is determined, the second part of the study will begin.

Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab

Phase I/II Study of Seleno-L Methionine (SLM) in Sequential Combination With Fixed Doses and Schedules of Axitinib and Pembrolizumab (SAP) in Locally Advanced and Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients

ORR will be defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

PFS will be defined as the time from treatment initiation to the date of first documentation of disease progression or death due to any cause

OS will be defined as the time from treatment initiation to the date of death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients	NCT06389682	Clear Cell Rena...	68Ga-NYM005 inj...	18 Years - 75 Years	Norroy Bioscience Co., LTD
Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours	NCT05698238	Clear Cell Rena... TNBC - Triple-N... Head and Neck C... Non-small-cell ... Mesothelioma, M...	CA9hu-1	18 Years - 80 Years	Mabpro, a.s.
Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours	NCT05698238	Clear Cell Rena... TNBC - Triple-N... Head and Neck C... Non-small-cell ... Mesothelioma, M...	CA9hu-1	18 Years - 80 Years	Mabpro, a.s.
The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial	NCT05753839	Kidney Cancer Clear Cell Rena... Synchronous Neo...	Cytoreductive n... Cytoreductive n... Human-derived m...	18 Years -	Yonsei University
The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial	NCT05753839	Kidney Cancer Clear Cell Rena... Synchronous Neo...	Cytoreductive n... Cytoreductive n... Human-derived m...	18 Years -	Yonsei University
Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours	NCT05698238	Clear Cell Rena... TNBC - Triple-N... Head and Neck C... Non-small-cell ... Mesothelioma, M...	CA9hu-1	18 Years - 80 Years	Mabpro, a.s.
Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab	NCT05363631	Clear Cell Rena... Clear Cell Rena...	Selenomethionin... Axitinib Pembrolizumab	18 Years -	University of Iowa

Spots Global Cancer Trial Database for clear cell renal cell carcinoma metastatic