SIBP-01 (trastuzumab biosimilar) / Sinopharm - LARVOL DELTA

A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer (clinicaltrials.gov) - P3 | N=580 | Completed | Sponsor: Shanghai Institute Of Biological Products | Unknown status ➔ Completed | Trial completion date: Jul 2021 ➔ Apr 2023 | Trial primary completion date: May 2021 ➔ Apr 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3; N=312; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3; N=212; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer (clinicaltrials.gov) - P3; N=3260; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3; N=212; Recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3; N=312; Recruiting; Sponsor: National Cancer Institute (NCI); N=212 ➔ 312

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3; N=312; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Mar 2018 ➔ Aug 2021

Clinical • Trial primary completion date • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • ER • HER-2

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer (clinicaltrials.gov) - P3; N=3260; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Jan 2017 ➔ Aug 2017

Clinical • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3; N=312; Recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Jan 2017 ➔ Mar 2018

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3; N=600; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Initiation date: Jul 2018 ➔ May 2019

Clinical • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • PD-L1 • PGR

Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3; N=480; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P3 trial • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • ER • PD-L1 • PGR

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=3000; Suspended; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Jun 2022 ➔ Aug 2021

Biomarker • Clinical • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2; N=108; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • Combination therapy • New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA • PTEN

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=3000; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Biomarker • Clinical • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4

Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Dec 2020 ➔ Jan 2023; Trial primary completion date: Dec 2020 ➔ Jan 2023

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • PD-L1 • PGR

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=3000; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Biomarker • Clinical • Enrollment open • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=6452; Recruiting; Sponsor: National Cancer Institute (NCI)

Biomarker • Clinical • New P2 trial • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Glioblastoma • Glioma • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Multiple Myeloma • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Thyroid Gland Carcinoma • Uterine Cancer • CD4

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2; N=12; Recruiting; Sponsor: National Cancer Institute (NCI); N=96 ➔ 12

Clinical • Combination therapy • Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA • PTEN

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=3000; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Biomarker • Clinical • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4

Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • PD-L1 • PGR

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2; N=108; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; Trial completion date: Nov 2021 ➔ Jun 2022; Trial primary completion date: Nov 2021 ➔ Jun 2022

Clinical • Combination therapy • Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA • PTEN

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=6452; Recruiting; Sponsor: National Cancer Institute (NCI); N=3000 ➔ 6452

Biomarker • Clinical • Enrollment change • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=3000; Suspended; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Aug 2021 ➔ Jun 2022

Biomarker • Clinical • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2; N=3000; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Initiation date: Oct 2015 ➔ Jul 2015

Biomarker • Clinical • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4

A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers. (PubMed, Expert Opin Drug Metab Toxicol) - "This study showed the PK similarity of SIBP-01 to Herceptin®. SIBP-01 was safe and well tolerated in healthy male volunteers, with no significant differences from the reference drug in safety or immunogenicity."

Clinical • Journal • P1 data • PK/PD data • Oncology