Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Disitamab vedotin

Immunoconjugates

Immunologic Factors

2.0 mg/kg, intravenous infusion，D1, every 2 weeks is a treatment cycle

Disitamab Vedotin Injection

Jianmin Fang, Ph.D

Zhisong He, M.D

Xu Zhang, M.D

Xu Zhang

Jun Guo, Ph.D

The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.

This is a Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects with locally advanced or metastatic castration-resistant prostate cancer.

The study plans to enroll 40 subjects with locally advanced or metastatic CRPC with HER2 expression (IHC 1+ and above) who have been treated with androgen deprivation therapy and novel hormone therapy. Eligible subjects were enrolled and received RC48 intravenous infusion at a dose of 2.0 mg/kg every 2 weeks. Subjects received medication until disease progression, intolerable toxicity, active withdrawal, death, or study termination by the sponsor.

Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer

A Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer

Define imaging disease progression according to RECIST v1.1 (for all lesions except bone lesions) or PCWG3 (for bone lesions) as the time from the first dose of the drug to the time when the imaging shows disease progression or death.

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

Percentage of patients with complete response, partial response, or stable disease for a certain period of time according to RECIST v1.1.

Defined as time from date of first dose to first PSA progression

Defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by Investigators assessment according to RECIST 1.1

Percent of subjects with different degree of decrease in PSA compared to baseline

Defined as the time from the first dose to the first occurrence of SSE.

OS was defined as the time from the date of randomization to the date of death from any cause.

Area under the plasma concentration versus time curve of RC48

Area under the plasma concentration versus time curve of MMAE

Anti-drug antibody (ADA) of RC48 positive samples, etc.

Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0

To be summarized using descriptive statistics

RemeGen Co., Ltd.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Pertuzumab

Antineoplastic Agents, Immunological

Disitamab Vedotin+ Toripalimab with Pertuzumab arm

2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.

Initial dose 840mg, after 2nd dose 420mg intravenous infusion， every 3 weeks

Pertuzumab Injection

3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Toripalimab

Jiong Wu, Ph.D

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.

This is an open-label, randomized, multicenter, Phase II Study designed to evaluate safety and efficacy of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy inr patients with HER2-positive breast cancer.

The primary objectives of the study are to explore combination neoadjuvant therapy in participants with previously untreated HER2-positive breast cancer, by assessment of pCR .

DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer

A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer

Pathological complete response rate after neoadjuvant ( both breast and axillary lymph nodes, in which the breast may have residual carcinoma in situ);

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

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

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;

OS is defined as the time from the date of randomisation until the date of death due to any cause.

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.

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Disease Progression

Esophageal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Phase II and III study ：2.5mg/kg, intravenous infusion，D1, every 2 weeks

Phase II and III study ：6.0mg/kg, intravenous infusion，D1, every 2 weeks.

Cadonilimab Injection

Phase II and III study ：Calculate dosage based on body surface are,160mg/m2,intravenous infusion，D1,D8 every 3 weeks

Paclitaxel Injection

Lin Shen, M.D.

Lin Shen, M.D

Feng Ye, M.D

Yanqiao Zhang, M.D

Yanru Qin, M.D

Huiting Xu, M.D

Zhenyang Liu, M.D

Yuan Yuan, M.D

Changzheng Li, M.D

Changzheng Li

Jing Lv, M.D

Jun Zhang, M.D

Hongfeng Gou, M.D

Lin Xie, M.D

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

This is an open-label, randomized, multicenter, Phase II/III Study designed to evaluate safety and efficacy of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

This clinical study was divided into two parts, phase II and III.Part I: Phase II study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus Disitamab Vedotin versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Part II: Phase III study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (±7 days) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first).

All patients who discontinue treatment will be followed for survival every 3 months until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (whichever comes first).

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

A Randomized，Multicenter, Open-Label，Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy

PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)

According to NCI-CTCAE Version 5.0 per each treatment arm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer	NCT06227156	Castration-resi...	Disitamab Vedot...	18 Years -	RemeGen Co., Ltd.
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer	NCT06178159	Breast Cancer	Disitamab Vedot... Pertuzumab Inje... Toripalimab	18 Years -	RemeGen Co., Ltd.
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy	NCT06221748	Gastric Cancer Gastroesophagea...	Disitamab Vedot... Cadonilimab Inj... Paclitaxel Inje...	18 Years - 75 Years	RemeGen Co., Ltd.

Spots Global Cancer Trial Database for disitamab vedotin injection