A5076065186- Monoclonal and Polyclonal Antibodies Research
- HER2/EGFR in Cancer Research
- Radiopharmaceutical Chemistry and Applications
- Biosimilars and Bioanalytical Methods
- Cancer Immunotherapy and Biomarkers
- Cancer Treatment and Pharmacology
- Immunotherapy and Immune Responses
- CAR-T cell therapy research
- Cutaneous Melanoma Detection and Management
- Advanced Breast Cancer Therapies
- Cancer Research and Treatments
- Cancer, Stress, Anesthesia, and Immune Response
- Breast Cancer Treatment Studies
- Cancer therapeutics and mechanisms
- Ovarian cancer diagnosis and treatment
- Protein Degradation and Inhibitors
- Multiple Myeloma Research and Treatments
- Brain Metastases and Treatment
- Lymphoma Diagnosis and Treatment
- Endometrial and Cervical Cancer Treatments
- Retinoids in leukemia and cellular processes
- Lung Cancer Treatments and Mutations
- Lung Cancer Research Studies
- Estrogen and related hormone effects
- Histone Deacetylase Inhibitors Research
Pfizer (United States)
2019-2023
Dynavax Technologies (United States)
2016-2018
Merck & Co., Inc., Rahway, NJ, USA (United States)
2016
Centre Hospitalier Universitaire de Liège
2011-2013
Gynecologic Oncology Associates
2013
Providence College
2013
Nektar Therapeutics (United States)
2012
Institut Jules Bordet
2011
Université Libre de Bruxelles
2011
Velindre Cancer Centre
2011
Abstract PD-1 inhibitors are approved for treating advanced melanoma, but resistance has been observed. This phase Ib trial evaluated intratumoral SD-101, a synthetic CpG oligonucleotide that stimulates Toll-like receptor 9 (TLR9), in combination with pembrolizumab patients unresectable or metastatic malignant melanoma. The most common adverse events related to SD-101 were injection-site reactions and transient, mild-to-moderate “flu-like” symptoms. Among the naïve anti–PD-1 therapy, overall...
Abstract PF-06804103 is an anti-HER2 antibody–drug conjugate with auristatin payload. We evaluated its safety, tolerability, and antitumor activity in patients advanced/unresectable or metastatic breast gastric cancers. This multicenter, open-label, first-in-human, phase 1 study (NCT03284723) comprised dose escalation (P1) expansion (P2). In P1, adults HER2+ cancer received 0.15–5.0 mg/kg intravenously once/21 days (Q3W); P2, HER2-low (IHC 1+ IHC 2+/ISH−) 3.0 4.0 Q3W. The primary endpoints...
1039 Background: PF-06804103 is an anti-HER2 immunoglobulin G1 antibody-drug conjugate (ADC), comprising monoclonal antibody conjugated with a cleavable linker to the cytotoxic agent Aur0101. demonstrated strong activity in low high HER2-expressing preclinical tumor models. In this study, safety and tolerability of was assessed patients advanced breast cancer (BC) or gastric (GC). Methods: This multi-center, open-label, first-in-patient, phase I study (NCT03284723) has two parts: dose...
Etirinotecan pegol (NKTR-102) is a unique, long-acting topoisomerase-I inhibitor with prolonged systemic exposure to SN38 (7-ethyl-10-hydroxycamptothecin), the active metabolite of irinotecan. This randomized phase II trial investigated two dosing schedules etirinotecan in patients platinum-resistant/refractory ovarian carcinoma.
e14123 Background: Bromodomains (BRD) bind to acetylated lysine residues on histone tails and are directly involved in remodeling chromatin regulating transcription, thus representing a potentially important anticancer target. MK-8628 is synthetic small molecule targeting BRD2, 3 4 of the tandem-BRD-containing family transcriptional regulators, BET proteins. It has shown cytotoxic activity vitro GB models. We conducted phase IIa trial with dose optimization determine MTD, safety clinical pts...
Abstract Background and Objectives: SD-101 is a synthetic CpG-ODN agonist of TLR9 that stimulates dendritic cells to release IFN-alpha mature into antigen presenting activate T cell anti-tumor responses. Pembrolizumab PD-1 inhibitor has demonstrated activity in HNSCC with ORR 14%. Study DV3-MEL-01 (NCT02521870) assesses the safety preliminary efficacy combination pembrolizumab patients recurrent or metastatic HNSCC. Methods: In phase 2 expansion cohort for anti-PD-1 treatment naïve patients,...
9550 Background: SD-101 is a synthetic CpG-ODN agonist of TLR 9 that stimulates dendritic cells to release IFN-alpha and mature into antigen presenting activate T cell anti-tumor responses. Pembro PD-1 inhibitor approved for the treatment metastatic melanoma. This study, MEL-01 (NCT02521870), assesses safety preliminary efficacy in combination with pembro stage IIIC-IV Methods: A modified 3+3 design was used dose escalation 1, 2, 4, 8 mg injected single tumor lesion Q1W x 4 then Q3W 7 (200...
9513 Background: SD-101 is a CpG-ODN agonist of TLR9. Pembrolizumab PD-1 inhibitor. DV3-MEL-01 (NCT02521870) assesses safety and preliminary efficacy the combination pembrolizumab in stage IIIC-IV melanoma. Methods: Phase 1b evaluated at multiple doses injected single tumor Q1W x 4 then Q3W 7 with fixed dose (200 mg IV Q3W); both drugs started on D1. 2 evaluating 8 1 lesion mg/lesion 2-4 lesions beginning 21 days after first pembrolizumab. First scan was performed D64, 6 weeks therapy....
605 Background: T-DM1, an antibody–drug conjugate comprising trastuzumab, DM1 (microtubule inhibitor), and a stable linker, is approved for patients (pts) with HER2-positive metastatic BC previously treated trastuzumab taxane. In two phase 3 studies, T-DM1 prolonged progression-free survival (PFS; EMILIA, TH3RESA) overall (EMILIA) v control arms. Here we examine the relationship between tissue BM related to HER2 pathway PFS in TH3RESA (NCT01419197). Methods: Pts had prior taxane therapy ≥2...
153 Background: Progression-free survival and objective response rate were significantly improved with T-DM1 vs TPC in TH3RESA. The impact of treatment on quality life is a key aspect determining value. Here we present the PRO results from TH3RESA study. Methods: Patients randomized 2:1 to (3.6 mg/kg every 21 days) or TPC. asked complete EORTC QLQ-C30 (a 30-item questionnaire assessing symptom bother, functioning health status) QLQ-BM22 22-item survey evaluating pain bone metastases) at...
<p>Supplementary File 1 shows the Methods and Results for Part 1B</p>
<p>Supplementary Figure S1 shows the study design.</p>
<div>Abstract<p>PF-06804103 is an anti-HER2 antibody-drug conjugate with auristatin payload. We evaluated its safety, tolerability, and antitumor activity in patients advanced/unresectable or metastatic breast cancer gastric cancer. This multicenter, open-label, first-in-human, phase 1 study (NCT03284723) comprised dose escalation (P1) expansion (P2). In P1, adults HER2+ received PF-06804103 0.15–5.0 mg/kg intravenously once/21 days (Q3W); P2, HER2-low (immunohistochemistry [IHC]...
<p>Supplementary Figure S1 shows the study design.</p>
<p>Supplementary Figure S3 shows the time to and duration of response in patients with confirmed CR or PR (the mITT population)</p>
<p>Supplementary Figure S2 shows the duration of treatment including response and tumor type (the safety analysis set)</p>