plozalizumab (TAK-202) / Takeda - LARVOL DELTA

Population-Based Modeling to Predict Human PK/PD of TAK-500, an Anti-CCR2 Antibody-Drug Conjugate for First-in-Human Study in Cancer Patients. (PubMed, Clin Transl Sci) - P1, P1/2 | "TAK-500 is a novel immune cell-directed antibody-drug conjugate (iADC) composed of TAK-202, an anti-CCR2 monoclonal antibody, conjugated to the STING agonist dazostinag (TAK-676), and is designed to stimulate antitumor immunity by reprogramming CCR2-positive monocytes. These findings demonstrate the feasibility of predicting TAK-500 PK and RO in humans by integrating preclinical and parental antibody clinical data, providing a quantitative framework for first-in-human dose selection of immune cell-directed ADCs. Trial Registration: Clinical trials: NCT04420884, NCT04879849."

First-in-human • Journal • P1 data • PK/PD data • Oncology • CCR2

Phase 1b Study of Tovorafenib, Plozalizumab or Vedolizumab Plus Standard-of-Care Immune Checkpoint Inhibitors in Patients with Advanced Melanoma. (PubMed, J Cancer) - "Background: Novel advanced melanoma therapy combinations may increase treatment efficacy and reduce treatment-related toxicities. Efficacy remains inconclusive for tovorafenib plus nivolumab and vedolizumab plus nivolumab plus ipilimumab in advanced melanoma. Trend review in this small population suggests a limited effect of investigated vedolizumab regimens as primary prophylaxis against nivolumab plus ipilimumab gastrointestinal toxicity."

Checkpoint inhibition • Journal • P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Melanoma • Oncology • Solid Tumor

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Millennium Pharmaceuticals, Inc. | Phase classification: P1b ➔ P1

Checkpoint inhibition • Combination therapy • Metastases • Phase classification • Melanoma • Oncology • Solid Tumor • BRAF • NRAS

A Systems Biology Approach for Investigating Significant Biomarkers and Drug Targets Common Among Patients with Gonorrhea, Chlamydia, and Prostate Cancer: A Pilot Study. (PubMed, Bioinform Biol Insights) - "Three potential therapeutic compounds namely INCB3284, CCX915, and MLN-1202 were found to interact with up-regulated protein C-C chemokine receptor type 2 (CCR2) in protein-drug interaction analysis. The proposed biomarkers and therapeutic potential molecules could be investigated for potential pharmacological targets and activity in the fight against in patients with gonorrhea, chlamydia, and prostate cancer."

Biomarker • Journal • Genito-urinary Cancer • Infectious Disease • Oncology • Prostate Cancer • Solid Tumor • APP • CCR2 • DERL1 • GATA6 • HIVEP1 • KMT2B • MARCKS • MIR7 • PRNP • PROS1 • PTGS1 • SH3BGRL • SLC40A1 • SLFN11

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma (clinicaltrials.gov) - P1b; N=22; Terminated; Sponsor: Millennium Pharmaceuticals, Inc.; N=156 ➔ 22; Trial completion date: Nov 2018 ➔ May 2018; Recruiting ➔ Terminated; Trial primary completion date: Nov 2018 ➔ May 2018; Business decision: Protocol efficacy futility met

Checkpoint inhibition • Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Immune Modulation • Inflammation • Melanoma • BRAF • NRAS

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma (clinicaltrials.gov) - P1; N=156; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Combination therapy • Enrollment open • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • BRAF • NRAS

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma (clinicaltrials.gov) - P1b; N=156; Recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Phase classification: P1 ➔ P1b

Checkpoint inhibition • Clinical • Combination therapy • Phase classification • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • BRAF • NRAS