Product Candidates

Rucaparib

Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds global rights for rucaparib.

FAP-2286 and Clovis' Targeted Radionuclide Therapy Development Program

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. The Phase 1/2 LuMIERE study of FAP-2286 is enrolling. FAP is highly expressed in cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, at varying levels, potentially making it a suitable target across a wide range of tumors. High FAP expression has been shown in multiple tumor types including pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous NSCLC, and head and neck cancers as well as in cancers of unknown primary. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade.[i] Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

Clovis also has global rights to three additional discovery-stage compounds in its Targeted Radionuclide Development Program.

For more information about FAP-2286, Targeted Radionuclide Therapy (TRT), or Clovis’ TRT development program CLICK HERE.

Lucitanib

Lucitanib, an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). The LIO-1 Phase 2 study, evaluating lucitanib and nivolumab in gynecologic cancers is underway. Clovis holds global rights for lucitanib excluding China.

 

 

[i] Kwan T et al. Pan-Cancer Analysis of Fibroblast Activation Protein Alpha (FAP) Expression to Guide Tumor Selection for the Peptide-Targeted Radionuclide Therapy FAP-2286. Virtual Presentation 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, 2021.

 

Clovis-Sponsored Studies

ATHENA

Monotherapy in Ovarian Cancer

  • Trial Name

    ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

  • Overview

    Phase 3 study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating rucaparib plus nivolumab (PD-1 inhibitor), rucaparib, nivolumab and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. The primary endpoint of this study is PFS. This study is part of a broad clinical collaboration with Bristol Myers Squibb. 

  • Status

    Enrollment Complete

  • Study Identifier

    NCT03522246

ATHENA

Combination with Nivolumab in Ovarian Cancer

  • Trial Name

    ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

  • Overview

    Phase 3 study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating rucaparib plus nivolumab (PD-1 inhibitor), rucaparib, nivolumab and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. The primary endpoint of this study is PFS. This study is part of a broad clinical collaboration with Bristol Myers Squibb.

  • Status

    Enrollment Complete

  • Study Identifier

    NCT03522246

TRITON3

Prostate Cancer

  • Trial Name

    TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency

  • Overview

    Randomized open-label Phase 3 study evaluating the effects of rucaparib compared to physician’s choice of therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) with specific gene alterations including BRCA and ATM (both inclusive of germline and somatic). Not all patients will receive rucaparib. As part of this study, genetic testing results will be provided. Eligible patients must have progressed on one prior androgen-receptor targeted therapy and must not have received prior chemotherapy for castration-resistant prostate cancer. The primary endpoint of the study is progression-free survival. For more information, please visit www.tritontrials.com.

  • Status

    Enrolling

  • Study Identifier

    NCT02975934

LODESTAR

Solid Tumors with Mutations in HRR Genes

  • Trial Name

    Rucaparib in Patients with Solid Tumors and with Deleterious Mutations in Homologous Recombination Repair (HRR) Genes (LODESTAR)

  • Overview

    A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in patients with various solid tumors and with deleterious mutations in homologous recombination repair (HRR) genes

  • Status

    Enrolling

  • Study Identifier

    NCT04171700

LuMIERE

Solid Tumors

  • Trial Name

    LuMIERE

  • Overview

    A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177LuFAP-2286 in Patients with an Advanced Solid Tumor

  • Status

    Enrolling

  • Study Identifier

    NCT04939610

LIO-1

with Nivolumab in Gynecologic Cancers

  • Trial Name

    A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

  • Overview

    Phase 1b/2, open-label study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2). This study is part of a broad clinical collaboration with Bristol Myers Squibb.

     

     

  • Status

    Enrolling

  • Study Identifier

    NCT04042116

PARTNER AND RESEARCH INSTITUTION-SPONSORED STUDIES

CASPAR

with Enzalutamide in Prostate Cancer

  • Trial Name

    A Phase 3 Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy

  • Overview

    This randomized, placebo-controlled phase 3 trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). This study is sponsored by the Alliance for Clinical Trials in Oncology which is part of the National Cancer Institute.

  • Status

    Enrolling

  • Study Identifier

    NCT04455750

CheckMate 9KD

with Nivolumab in Prostate Cancer

  • Trial Name

    A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

  • Overview

    A Phase 2 Investigational immunotherapy study of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in metastatic castration-resistance prostate cancer (mCRPC). The nivolumab + rucaparib combination in mCRPC is being conducted as an arm of a larger Bristol Myers Squibb-sponsored study. This study is sponsored by Bristol Myers Squibb.

  • Status

    Enrollment Complete

  • Study Identifier

    NCT03338790

FRACTION-GC

with Nivolumab and Ipilimumab in Gastric Cancer

  • Trial Name

    A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer (FRACTION-GC)

  • Overview

    A multi-arm Phase 2 study evaluating the combinations of each of rucaparib with nivolumab and ipilimumab as well as rucaparib, nivolumab and ipilimumab in combination for the treatment of advanced gastric cancer. This study is sponsored by Bristol Myers Squibb.  

     

  • Status

    Enrollment Complete

  • Study Identifier

    NCT02935634