Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Tislelizumab

Disitamab vedotin

Aflutinib

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

RC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations

RC48+Tislelizumab+carboplatin

RC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2 alterations

RC48+Furmonertinib, 1L

RC48+Furmonertinib in patients who failed at least one line of standard treatment and harboring HER2 alterations

RC48+Furmonertinib, 2L+

Li PI Zhang, MD

Li Zhang, MD

Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.

This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 mutation (mutation, amplification, protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC With HER2 Alterations, a Phase II Study

Percentage of Participants who have a complete response (CR) or partial response (PR) as assessed by investigator according to RECIST 1.1

Defined as the proportion of participants who have a complete response (CR), partial response (PR) or standard disease (SD) as assessed by investigator according to RECIST 1.1

Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.

Defined as the time from the date of first documented response until date of documented progression as assessed by investigator assessment according to RECIST 1.1.

Defined as time from randomization until the date of death due to any cause.

Sun Yat-sen University

Head of Oncology Department

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antibodies

Immunoglobulins

Disitamb Vedotin

Evaluate the efficacy and safety of Disitamb Vedotin in patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer

The main goal of this clinical trial is to examinie the utilization of RC48 in different HER2 statuses, elucidating its clinical outcomes and safety, and investigating the factors that influence its clinical efficacy. The primary endpoint was the objective response rate (ORR) assessed by the primary researcher. Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), time to progression, and safety.

A Multicenter and Real-world Analysis of RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer

A Multicenter and Real-world Analysis of Clinical Outcomes and Safety of the Novel Recombinant Humanized Anti-HER2 Therapeutic Antibody RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer

Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set

Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

It is defined as the time from the start of treatment to death for any reason.

The First Affiliated Hospital with Nanjing Medical University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

BCG Vaccine

Immunoconjugates

Immunologic Factors

Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks).

RC48 was scheduled to be administered at a dose of 2.0mg/kg every 2 weeks, with the first dose on day 1 of the first cycle.

The drug is diluted with normal saline and administered by intravenous drip for one hour.

RC48

Tislelizumab was administered at a dose of 200 mg every 3 weeks, with the first dose on day 1 of the first 21-day cycle.

The drug is diluted with normal saline and administered by intravenous drip for one hour.

Wei Xue, Doctor

Ming Cao, Doctor

Qi Lu

This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks).

Subjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue.

The study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy.

Subjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.

For Non-muscle invasive bladder cancer (NMIBC), Transurethral resection of bladder tumor (TURBT) is the primary treatment. TURBT relapses within 12 months after surgery in 10% to 67% of patients, and postoperative bladder perfusion therapy (including chemotherapy and Immunotherapy) significantly reduces the recurrence rate. However, about 30%-40% of patients will relapse after BCG treatment. Radical cystectomy is the standard of care for patients who do not respond to BCG treatment and have high grade NMIBC. However, radical cystectomy has a high incidence of postoperative complications (up to 60%) and a negative impact on HRQoL. These complications occur even in high-volume centers of excellence, whether open or minimally invasive, and the mortality rate from the surgery itself is about 3%. Therefore, some patients refuse to undergo radical cystectomy. In addition, some patients are medically unfit for surgery due to age, functional status, American Society of Anesthesiologists classification, comorbiditions, body mass index, and other factors. Although penerubicin is the only bladder sparing drug approved by the U.S. Food and Drug Administration (FDA) for patients who are not suitable for or unwilling to undergo cystectomy, BCG refractory, and with CIS NMIBC, no legally marketed penerubicin drug is available in China. Therefore, new treatments are needed to prevent invasive bladder cancer from affecting the entire bladder.

In recent years, immunocheckpoint inhibitors represented by PD-1/PD-L1 have been proved to be a promising means of tumor immunotherapy, which has made a breakthrough in the treatment of advanced urothelial carcinoma, and become the main choice for the treatment of advanced urothelial carcinoma. Immunocheckpoint inhibitors also showed positive results in patients who did not respond to BCG treatment during perioperative and perioperative periods.Therefore, immunotherapy is expected to be an alternative bladder sparing therapy for high-risk NMIBC patients.The anti-HER2-ADC drug RC48 also achieved significant efficacy in HER2-overexpressed advanced urothelial carcinoma, and its combination with PD-1 monoclonal antibody Toripalimab was more effective in the first-line treatment of advanced metastatic urothelial carcinoma. Therefore, RC48 combined with PD-1 can be used as a potential treatment for bladder sparing in patients with NMIBC.

In NMIBC patients with HER2 expression, ADC drugs can target tumor cells and deliver cytotoxic drugs with greater safety than chemotherapy. In addition, the application of anti-HER2-ADC drugs combined with PD-1 in bladder sparing therapy is still lacking in experience and related studies. Therefore, we plan to conduct a study on bladder preservation therapy for patients with HER2-expressing NMIBC treated with ADC drugs combined with PD-1 monoclonal antibody, so as to preserve the bladder function of patients while controlling tumor recurrence and ensuring their quality of life.

To study the safety and efficacy of RC48 combined with Tislelizumab in HER2 expression high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.

RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression

RC48 Combined With Tislelizumab for Bladder Sparing Treatment in High-risk Non-muscular Invasive Bladder Cancer (NMIBC) With BCG Treatment Failure and HER2 Expression

Defined by time from enrollment to the occurrence of one of the following events: first MIBC or regional lymph node recurrence, distant metastasis, or death

Defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause.

Defined by time from day of first treatment to first deterioration

Defined by time from day of first treatment to radical cystectomy

Defined by time from day of first treatment to invasive bladder cancer

Defined by time from day of first treatment to death

CR is defined by negative cystoscopy, urine cytology, and bladder biopsies.

Defined by time from day of first treatment to recurrent NMIBC based on cystoscopy, cytology and/or biopsy.

RemeGen Co., Ltd.

BeiGene

RenJi Hospital

Rare Diseases

Carcinoma, Transitional Cell

Transitional Cell Carcinoma

Gemcitabine

Cisplatin

Antimetabolites

Participants will receive RC48-ADC + JS001 every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).

Participants will receive Gemcitabine + cisplatin or carboplatin every 3 weeks (Q3W) for maximum 6 weeks or until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).

RC48-ADC

Toripalimab

1000mg/m2 IV infusion on Days 1 and 8 of every 3 week cycle

70mg/m2 IV infusion on Day 1 of every 3 week cycle

AUC=4.5, IV infusion on Day 1 of every 3 week cycle

Jianmin Fang, PhD

Aiping zhou

Jun Guo

Na Su, PhD

This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study to evaluate the efficacy and safety of RC48-ADC,a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in Combination With JS001,a PD-1 monoclonal antibody, for the treatment of Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing

Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by independent review committee according to the RECIST 1.1 standard.

Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).

Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.

Disitamab Vedotin : 2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days.

Disitamab Vedotin:2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days.

Disitamab Vedotin+Anlotinib

Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The aim of this study is to evaluate the efficacy and safety of RC48 in Combination with Anlotinib for the treatment of metastatic breast cancer with HR negativity and HER2 low expression.

Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer

Combination of Disitamab Vedotin and Anlotinib in the Treatment of HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer: A Single-Arm, Multicenter, Phase II Clinical Study

The percentage of cases that have achieved complete or partial remission after drug treatment compared to the total evaluable cases.

All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.

Defined as the time from the beginning of the patient's treatment to death from any cause.

The proportion of patients who achieve complete remission (CR), partial remission (PR), or disease stability (SD) during or after treatment

Defined as the date from which tumor remission was first recorded (evaluated according to the RECIST 1.1 standard) to the date when disease progression was first recorded (evaluated according to the RECIST 1.1 standard) or the date of death from any cause.

Qilu Hospital of Shandong University

Pembrolizumab

Immune Checkpoint Inhibitors

Given into the vein (IV; intravenous) every 2 weeks.

disitamab vedotin

Given by IV on Day 1 of each 6-week cycle.

pembrolizumab

Seagen Trial Information Support

Isaac Bowman

Abhishek Tripathi

Alexandra Drakaki

Nataliya Mar

Helen Moon

Vadim Koshkin

Amir Harandi

Pareshkumar Patel

Rohit Jain

Barry Berman

Steve McCune

Peter H O'Donnell

Clara Hwang

Elisabeth Heath

Eric Batts, MD

Oscar B Goodman Jr.

Thomas P Bradley

Matthew Galsky

Gopakumar Iyer

Earle Burgess

Jason Robert Brown

Saikrishna Gadde

Matthew T Campbell

Jeanny B Aragon-Ching, MD, F.A.C.P.

Evan Yu

Ariel Nelson

Mirta Varela

Gabriela Gatica

Hernan Cutuli

Juan Pablo Sade

Mark McGregor

Sanjeev Sewak

Niara Oliveira

Laurence Krieger, MD

Aaron R. Hansen

Alison Zhang

Bernhard Eigl

Joel Gingerich

April Rose, MD, PhD

Michel Pavic

Luisa Morales Galindo

Carolina Ibanez

Pamela Salman

Avivit Pe'er

Victoria Neiman

Michal Sarfaty

David Sarid

Nobuaki Matsubara

Masashi Nakayama

Naoya Masumori

Atsunari Kawashima

Masayuki Takahashi

Takeshi Yuasa

Joachim Chan

Danish Mazhar

Robert Jones

Thomas Powles

Medical Monitor

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations	NCT05847764	Non Small Cell ... ERBB2 Mutation-... RC48 Disitamab Vedot...	RC48+Tislelizum... RC48+Furmonerti... RC48+Furmonerti...	18 Years -	Sun Yat-sen University
A Multicenter and Real-world Analysis of RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer	NCT06168227	Breast Cancer	Disitamb Vedoti...	18 Years - 85 Years	The First Affiliated Hospital with Nanjing Medical University
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression	NCT05957757	Non-Muscle Inva... HER2	RC48 Tislelizumab	18 Years -	RenJi Hospital
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma	NCT05302284	Urothelial Carc... HER2-expressing	RC48-ADC Toripalimab Gemcitabine Cisplatin Carboplatin	18 Years -	RemeGen Co., Ltd.
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer	NCT06000033	Breast Cancer	Disitamab Vedot...	18 Years -	Qilu Hospital of Shandong University
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression	NCT05957757	Non-Muscle Inva... HER2	RC48 Tislelizumab	18 Years -	RenJi Hospital
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2	NCT04879329	Urothelial Carc...	disitamab vedot... pembrolizumab	18 Years -	Seagen Inc.
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer	NCT06000033	Breast Cancer	Disitamab Vedot...	18 Years -	Qilu Hospital of Shandong University
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2	NCT04879329	Urothelial Carc...	disitamab vedot... pembrolizumab	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for rc48

Every month we try and update this database with for rc48 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rc48

Every month we try and update this database with for rc48 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rc48 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.