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. 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.

 

Targeted Therapy

Rucaparib (PARPi)

ATHENA-MONO

1st line maintenance OC

  • phase i

  • phase ii

  • phase iii

  • Study 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)

  • Summary

    ATHENA is an international, randomized, double-blind, Phase III trial consisting of 2 separate and independently powered comparisons, ATHENA-MONO and ATHENA-COMBO, in patients with newly diagnosed platinum-sensitive ovarian cancer. ATHENA-MONO will evaluate the efficacy of rucaparib monotherapy versus placebo in frontline maintenance of ovarian cancer.

  • Study Status

    Enrollment Complete

  • Study Identifier

    NCT03522246

ATHENA-COMBO

1st line maintenance OC w/ nivolumab

  • phase i

  • phase ii

  • phase iii

  • Study 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)

  • Summary

    ATHENA is an international, randomized, double-blind, Phase III trial consisting of 2 separate and independently powered comparisons, ATHENA-MONO and ATHENA-COMBO, in patients with newly diagnosed platinum-sensitive ovarian cancer. ATHENA-COMBO will evaluate whether adding nivolumab to rucaparib increases clinical benefit as compared with rucaparib alone in this setting.

  • Study Status

    Enrollment Complete

  • Study Identifier

    NCT03522246

TRITON3

2nd line mCRPC w/ BRCA or ATM mutations

  • phase i

  • phase ii

  • phase iii

  • Study Name

    A Study of Rucaparib Versus Physician’s Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3)

  • Summary

    The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

  • Study Status

    Enrollment Complete

  • Study Identifier

    NCT02975934

CASPAR

1st line mCRPC w/ enzalutamide

Sponsored by the Alliance for Clinical Trials in Oncology, part of the NCI

  • phase i

  • phase ii

  • phase iii

  • Study Name

    A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation therapy (CASPAR)

  • Summary

    This randomized, placebo-controlled phase III 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). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.

  • Study Status

    Enrolling

  • Study Identifier

    NCT04455750

Targeted Radionuclide Therapy

FAP-2286 (Fibroblast activation protein)

LuMIERE

Advanced solid tumors

  • discovery

  • preclinical

  • phase i

ISOTOPE(S)

  • Study Name

    Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)

  • Summary

    Phase 1 of this study will evaluate the safety and tolerability of 177Lu-FAP-2286 and determine the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors. Phase 2 of this study is designed to evaluate objective response rate (ORR) in patients with specific solid tumors.

  • Study Status

    Enrolling

  • Study Identifier

    NCT04939610

Imaging Using 68Ga FAP-2286

Solid tumors

Sponsored by UCSF

  • discovery

  • preclinical

  • phase i

ISOTOPE(S)

  • Study Name

    Imaging of Solid Tumors Using 68Ga-FAP-2286

  • Summary

    This is a single arm prospective trial that evaluates the ability of a novel imaging agent gallium-68 labelled (68Ga-) FAP-2286 (68Ga-FAP-2286) to detect metastatic cancer in participants with solid tumors using 68Ga-FAP-2286 tracer.

  • Study Status

    Enrolling

  • Study Identifier

    NCT04621435

2nd Generation Alpha-emitter

TBD

  • discovery

  • preclinical

ISOTOPE(S)

  • Study Name

    TBD

  • Summary

    TBD

  • Study Status

    Planned

Combination Program

TBD

  • discovery

  • preclinical

  • Study Name

    TBD

  • Summary

    TBD

  • Study Status

    Planned

Targeted Radionuclide Therapy Candidate A

TBD

  • discovery

  • preclinical

  • Study Name

    TBD

  • Target

    Target Undisclosed

  • Summary

    TBD

  • Study Status

    Planned

Targeted Radionuclide Therapy Candidate B

TBD

  • discovery

  • Study Name

    TBD

  • Target

    Target Undisclosed

  • Summary

    TBD

  • Study Status

    Planned

Targeted Radionuclide Therapy Candidate C

TBD

  • discovery

  • Target

    Target Undisclosed

  • Summary

    TBD

  • Study Status

    Planned

* Partnering with 3B Pharmaceuticals.

These trials are investigational, and these indications are not approved by any health authority.