Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All 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

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Disitamab vedotin

Immunoconjugates

Immunologic Factors

Participants will receive Disitamab Vedotin for injection Intravesical instiliations into the bladder for 1 hour, D1, once a week.

Intravesical instiliations into the bladder

Disitamab Vedotin for injection

Hong Luo

Tianxin Lin, Ph.D

Shusuan Jiang, M.D

qiang Lv, M.D

Jiasheng Bian, M.D

Yuping Sun

Lei Li, M.D

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2

This is a single-arm, multicenter phase I/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2.

To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade

Disease-free survival (DFS) rates was defined as the time from the date of first study treatment to the time of the subject's first high-grade Ta, T1 of any grade, CIS lasting greater than or equal to 6 months, new carcinoma in situ (CIS), cystectomy, disease progression, or death from any cause

Defined as the time from the start of the first assessment of CR to the first assessment of high grade Ta, any grade of T1, new CIS, disease progression, cystectomy, or death from any cause

The number and proportion of anti-drug antibody (ADA)-positive subjects were analyzed according to dose group and time point.

Cmax will be recorded from the PK blood samples collected.

Ctrough will be recorded from the PK blood samples collected.

RemeGen Co., Ltd.

Rare Diseases

Carcinoma, Transitional Cell

Transitional Cell Carcinoma

Antineoplastic Agents

Cisplatin

Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

After completion of all screening activities, patients confirmed to be eligible will enter the study and receive the following treatments.

Neoadjuvant regimen (up to 4 cycles): Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

Disitamab Vedotin for Injection,Penpulimab Injection

Tianxin Lin

This study is a one-arm exploratory clinical study of Disitamab Vedotin for Injection combined with Penpulimab Injection designed for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients.It will confirme the efficacy and safety of Disitamab Vedotin for Injection combined with Penpulimab Injection neoadjuvant treatment for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients. Finally, it will provide new evidence-based medical evidence for neoadjuvant therapy for such patients.

This study is a multicenter, open-label, single-arm prospective clinical study to evaluate the neoadjuvant treatment of Disitamab Vedotin for Injection combined with Penpulimab Injection in cisplatin-intolerant cT2-T4aNxM0 bladder urothelial carcinoma Efficacy and safety in patients. If the subject does not withdraw from the trial voluntarily, the toxic and side effects caused by the drug are intolerable, or the investigator believes that the subject is not suitable for further trials, each subject will undergo the following treatment after surgery, and in Efficacy evaluation and follow-up were performed in each cycle.

After completion of all screening activities, patients who are identified as eligible will enter the study and receive the following treatments and visits: Neoadjuvant therapy with Disitamab Vedotin for Injection combined with Penpulimab Injection (administered for a maximum of 4 cycles), every three One week is a medication cycle; patients received radical cystectomy after neoadjuvant chemotherapy; postoperative pathological complete remission rate, downstaging rate, and regular follow-up for two years were evaluated to evaluate the safety of the patients drugs/surgery, and to evaluate the patients new Survival after curative resection with adjuvant immunotherapy combined with chemotherapy.

Neoadjuvant regimen (up to 4 cycles): Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

Surgical plan: radical cystectomy + urinary diversion.

A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma

As assessed by the investigator,proportion of patients without residual tumor lesion among patients who underwent radical cystectomy after completion of clinical trial treatment.

The pathological downstaging rate is judged according to the pathological results after surgery whether the downstaging is below T2 stage.

Safety is evaluated by monitoring and recording all adverse events graded as NCI-CTCAE V5.0 or Clavien-Dindo.

Event-free survival (EFS) is the time from the start of the first neoadjuvant therapy to disease progression, death from any cause, or new development of other tumors.

Overall survival (OS) is defined as the time from the start of treatment to death from any cause.

Third Affiliated Hospital, Sun Yat-Sen University

Nanfang Hospital, Southern Medical University

Southern Medical University, China

The Third Affiliated Hospital of Southern Medical University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

chief physician

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Epirubicin

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Disitamab Vedotin combined with Toripalimab sequential chemotherapy arm

2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed

Disitamab Vedotin for Injection

3.0 mg/kg, intravenous infusion, D1, every 2 weeks, every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks,every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.

Toripalimab

According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed.

According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks , Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed

Leng Kang

Jiong Wu, Ph.D

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer

This is a single-arm, open-label, multicenter phase II clinical trial to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as neoadjuvant treatment in patients with HR-positive, HER2-low breast cancer

To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

Defined as the proportion of participants with a pathological assessment of pCR (ypT0/Tis, ypN0) in the analyzed population

Defined as the proportion of participants with a pathological assessment of bpCR in the analyzed population

The time from random assignment to disease progression, including local progression before surgery; disease recurrence-local, regional, distant, ipsilateral noninvasive, or contralateral (invasive or noninvasive)-or death from any cause

From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause including 3- and 5-year event-free survival

Objective response rate.ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)

To evaluate safety including adverse event rate and adverse event grade

CD8 in tumor samples by biopsy at baseline and by surgery immediately after surgery would be evaluated by HE or immune staining.

Change from baseline in the physical functioning subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/ QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden

According to the extent of the residual cancer in the primary breast cancer site (mm\*mm), the residual cancer (mm\*mm), cell density of residual cancer (%), proportion of carcinoma in situ (%), number of positive lymph nodes and maximum diameter of lymph node metastasis (mm), the RCB index and corresponding RCB classification can be obtained. The RCB index and the corresponding RCB grade can be obtained based on the maximum diameter of the cancer (mm).

Defined as infiltrating lymphocytes isolated from tumor tissue.TILs in tumor samples by biopsy right before the first neoadjuvant therapy (baseline) and by surgery immediately after surgery would be evaluated by HE or immune staining.

PD1 in tumor samples by biopsy at baseline and by surgery immediately after surgery would be evaluated by HE or immune staining.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2	NCT06378242	High-risk Non-m...	Disitamab Vedot...	18 Years - 75 Years	RemeGen Co., Ltd.
A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma	NCT05488353	Bladder Cancer	Disitamab Vedot...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer	NCT06389006	Breast Cancer	Disitamab Vedot... Toripalimab Epirubicin Cyclophosphamid...	18 Years -	RemeGen Co., Ltd.
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer	NCT06389006	Breast Cancer	Disitamab Vedot... Toripalimab Epirubicin Cyclophosphamid...	18 Years -	RemeGen Co., Ltd.
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2	NCT06378242	High-risk Non-m...	Disitamab Vedot...	18 Years - 75 Years	RemeGen Co., Ltd.

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