Development Therapeutics Branch Clinical Trials

Division Of Basic Sciences - Nci

Investigators

Linked publications & trials

Abstract

We focus on drugs targeting the genome, especially novel topoisomerase inhibitors as single agents and in combination with DNA repair and immune checkpoint inhibitors. One of our topoisomerase I (TOP1) inhibitors, LMP400 (Indotecan) finished Phase 1 clinical trials. Another (LMP776, Indimitecan) is finishing phase 1 and LMP744 is in phase 1. We have clinical trials with tumor-targeted TOP1 inhibitors (Onivyde, CRLX101, PLX-038 and PEN-866), and clinical trials with combination of TOP1 inhibitors with ataxia-telangiectasia and rad3-related (ATR), poly(ADPribose)polymerase (PARP1/2) and immune checkpoint inhibitors. Our ongoing clinical trials include: Actively recruiting: 13C0131: A Pilot Study of Inpatient Hospice with Procurement of Tissue on Expiration in Thoracic Malignancies; 15C0150: A Phase I/II Trial of Topotecan with VX-970 (M6620), an ATR Kinase Inhibitor in Small Cell Cancers; 16C0107: A Phase I/II Trial of CRLX101, a Nanoparticle Camptothecin with Olaparib in Patients with Relapsed/Refractory Small Cell Lung, Bladder and Prostate Cancers; 17C0117: A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of PEN-866 in Advanced Solid Malignancies; 18C0110: Safety Run-In and Phase II Trial of M7824 and Topotecan or Temozolomide in Relapsed Small Cell Cancers; 20C0009: Randomized Phase II Trial of Topotecan Plus M6620 (VX-970) vs. Topotecan Alone in Patients with Relapsed Small-Cell Lung Cancer; 20C0013: Phase I/II trial of PLX038 (PEGylated SN38) and Rucaparib in Solid tumors and Small Cell Cancers;17C0012: Ph I MM-398 plus Veliparib.