Nanoplatin (demplatin pegraglumer) / NANO MRNA, Orient Europharma - LARVOL DELTA

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (clinicaltrials.gov) - P1/2 | N=119 | Completed | Sponsor: NanoCarrier Co., Ltd. | Phase classification: P1b/2 ➔ P1/2 | N=209 ➔ 119

Combination therapy • Enrollment change • Metastases • Phase classification • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Exploratory Analysis of Lung Cancer Patients in a Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) plus Gemcitabine (WCLC 2017) - "The nanoparticle formulation allowed greater cisplatin equivalent doses with no clinically significant neuro-, oto- or nephrotoxicity allowing patients to receive treatment for a longer duration. Activity was observed in heavily pretreated platinum exposed lung cancer patients with a majority of patients exhibiting tumor regression or stable disease. NC-6004 with gemcitabine demonstrated promising activity and tolerability in heavily pretreated lung cancer patients in this trial and warrants further investigation."

Non Small Cell Lung Cancer • Small Cell Lung Cancer

Synthesis of doxorubicin-loaded peptosomes hybridized with gold nanorod for targeted drug delivery and CT imaging of metastatic breast cancer. (PubMed, J Nanobiotechnology) - "In this regard, the synthesized theranostic peptosomes offer innovative hybrid multipurpose platform for fighting against breast cancer."

Journal • Breast Cancer • Oncology • Solid Tumor

[VIRTUAL] Phase IIa/IIb clinical trial of NC-6004 (Nanoparticle Cisplatin) plus Pembrolizumab in patients with Head and Neck Cancer (HNSCC) who have failed platinum or a platinum-containing regimen (AACR-NCI-EORTC 2020) - "7 patients (44%) had prior cetuximab treatment. Although MTD and RP2D of 135 mg/m2 are higher than conventional CDDP doses usually used in HNSCC treatment, no clinically significant neuro-, oto- or nephrotoxicity was observed owing to the nanoparticle formulation. Thus, unlike the toxicity of CDDP, NC-6004 combination didn’t jeopardize the ability to deliver ICI, resulting in a combination regimen with a good safety profile. Overall, this data demonstrates promising activity and excellent tolerability of NC-6004 in conjunction with pembrolizumab in a platinum pre-treated population."

Clinical • IO Biomarker • P2a data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (clinicaltrials.gov) - P1b/2; N=209; Completed; Sponsor: NanoCarrier Co., Ltd.; Active, not recruiting ➔ Completed; Trial completion date: Nov 2019 ➔ May 2019; Trial primary completion date: Nov 2019 ➔ May 2019

Clinical • Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • ALK • EGFR

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (clinicaltrials.gov) - P1b/2; N=209; Active, not recruiting; Sponsor: NanoCarrier Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer • Urothelial Cancer • ALK • EGFR

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (clinicaltrials.gov) - P1b/2; N=85; Recruiting; Sponsor: NanoCarrier Co., Ltd.; Phase classification: P1/2 ➔ P1b/2; Trial primary completion date: May 2017 ➔ May 2018

Clinical • Combination therapy • Phase classification • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • ALK • EGFR

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (clinicaltrials.gov) - P1b/2; N=182; Recruiting; Sponsor: NanoCarrier Co., Ltd.; N=85 ➔ 182; Trial primary completion date: May 2018 ➔ Nov 2017

Clinical • Combination therapy • Enrollment change • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • ALK • EGFR

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (clinicaltrials.gov) - P1/2; N=85; Recruiting; Sponsor: Nanocarrier Co., Ltd.; Trial primary completion date: Jul 2015 ➔ May 2017

Clinical • Combination therapy • Trial primary completion date • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • ALK • EGFR

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (clinicaltrials.gov) - P1/2; N=85; Recruiting; Sponsor: Nanocarrier Co., Ltd.

Clinical • Combination therapy • New P1/2 trial • Biliary Tract Cancer • Bladder Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • ALK • EGFR

[VIRTUAL] Updated results of NC-6004 +Pembrolizumab for HNSCC patients who have failed platinum-containing regimen (JSMO 2021) - No abstract available

Clinical • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Effect of Nano-Platinum on Proliferation and Apoptosis of Non-Small Cell Lung Cancer Cells via P53 Pathway. (PubMed, J Nanosci Nanotechnol) - "Compared with cisplatin, nanoplatin can significantly inhibit the proliferation of non-small cell lung cancer cells and overcome its cisplatin resistance. The p53-related signaling pathway may participate in the process of apoptosis and reverse the process of cisplatin resistance, but the specific mechanism and whether there are other signaling pathways involved Further research is needed."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Phase IIa/IIb clinical trial of NC-6004 (Nanoparticle Cisplatin) plus Pembrolizumab in patients with Head and Neck Cancer (HNSCC) who have failed platinum or a platinum-containing regimen (AACR-NCI-EORTC 2020) - "7 patients (44%) had prior cetuximab treatment. Although MTD and RP2D of 135 mg/m2 are higher than conventional CDDP doses usually used in HNSCC treatment, no clinically significant neuro-, oto- or nephrotoxicity was observed owing to the nanoparticle formulation. Thus, unlike the toxicity of CDDP, NC-6004 combination didn’t jeopardize the ability to deliver ICI, resulting in a combination regimen with a good safety profile. Overall, this data demonstrates promising activity and excellent tolerability of NC-6004 in conjunction with pembrolizumab in a platinum pre-treated population."

Clinical • IO Biomarker • P2a data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

Cancer Nanomedicines Based on Synthetic Polypeptides. (PubMed, Biomacromolecules) - "A few polypeptide-based nanoformulations (e.g., NK105, NC6004, NK911, CT2103) are under phases I-III clinical investigation for treating patients with advanced solid tumors. Moreover, virus-mimicking vehicles have been devised from polypeptides for efficient non-viral delivery of highly potent peptides, proteins, and nucleic acids, greatly advancing biotherapy for cancers. In this perspective, we highlight the state-of-the-art design and fabrication of cancer nanomedicines based on synthetic polypeptides, and at the end give our viewpoints on their future development for targeted cancer therapy and potential challenges for clinical translation."

Journal • Oncology • Psychiatry • Solid Tumor

Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer (clinicaltrials.gov) - P1; N=4; Terminated; Sponsor: Orient Europharma Co., Ltd.; N=55 ➔ 4; Recruiting ➔ Terminated; Strategy change

Clinical • Combination therapy • Enrollment change • Trial termination • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A phase II study of neo-adjuvant gemcitabine, cisplatin and bevacizumab in stage IIIA (N2) non-squamous cell non-small cell lung cancer (clinicaltrials.gov) - P2, N=2; N=70 → 2; Recruiting → Completed; Completion date: Apr ’12 → Sep ‘11

Completion date • Enrollment • Trial completion • Non Small Cell Lung Cancer • Oncology

Sorafenib trial in advanced and/or recurrent gastric adenocarcinoma: Treatment evaluation (STARGATE) (clinicaltrials.gov) - P2, N=194, STARGATE; Not yet recruiting → Recruiting

Enrollment open • Oncology

Neoadjuvant pemetrexed plus cisplatin for patients with resectable "nonsquamous", non-small cell lung cancer with switch chemotherapy alternative in nonresponders (NEOSCAN) (clinicaltrials.gov) - P2, N=100; Not yet recruiting -> Recruiting

Enrollment open • Non Small Cell Lung Cancer

A study of IMC-A12 (cixutumumab) with and without other standard chemotherapies in patients with lung cancer who have not received chemotherapy before (clinicaltrials.gov) - P2, N=64; N= 90 → 64; Recruiting → Active, not recruiting

Enrollment • Enrollment closed • Non Small Cell Lung Cancer • Oncology

Phase I safety and tolerability study of cediranib (Recentin, AZD2171) in combination with chemo in first line lung cancer patients (clinicaltrials.gov) - P1, N=26; Active, not recruiting; Completion date: Sep ’11 → Sep ‘12

Completion date • Trial delayed • Oncology

Study in head and neck cancer (clinicaltrials.gov) - P2, N=30; Recruiting; Completion date: Aug ’13 → Aug ‘16

Completion date • Trial delayed • Oncology

Radiation therapy with cisplatin or Cetuximab in treating patients with oropharyngeal cancer (clinicaltrials.gov) - P3, N=706; Not yet recruiting; Start date: Feb’ 11 → Jun ’11

Start date • Oncology

A study of induction and maintenance treatment of advanced or metastatic non squamous non-small cell lung cancer (clinicaltrials.gov) - P2, N=112; Active, not recruiting; Completion date: Aug ’11 → Nov ‘11

Completion date • Non Small Cell Lung Cancer • Oncology

Radiation therapy, cisplatin, and etoposide in treating patients with non-small cell lung cancer that cannot be removed by surgery (clinicaltrials.gov) - P1, N=15; Recruiting; Not yet recruiting -> Recruiting; Completion date: Sep '11 -> Oct '11

Enrollment open • Non Small Cell Lung Cancer

Upregulation of microRNA-451 increases cisplatin sensitivity of non-small cell lung cancer cell line (A549) - N=20; Ectopic overexpression of miR-451 could significantly inhibit growth and induce apoptosis of A549 cells, increasing DDP-induced apoptosis which might be associated with the inactivation of Akt signaling pathway;