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A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.
This includes patients with Peripheral T-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCS1477 dose escalation NHL/MM | Experimental | CCS1477 monotherapy |
|
| CCS1477 dose escalation AML/Higher risk MDS | Experimental | CCS1477 monotherapy |
|
| CCS1477 monotherapy expansion and combination dose finding and expansion NHL | Experimental | CCS1477 monotherapy, CCS1477 combination with lenalidomide |
|
| CCS1477 monotherapy expansion and combination dose finding and expansion - MM | Experimental | CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab |
|
| CCS1477 monotherapy expansion and combination dose finding and expansion - AML | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCS1477 | Drug | Oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events | Treatment-related adverse events and serious adverse events | Up to 12 months |
| Incidence of laboratory abnormalities | Laboratory abnormalities characterised by type, frequency, severity and timing | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Defined as number of patients who have a response according to
| Up to 12 months |
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Knurowski, PhD | Contact | 07882871299 | Tomasz.Knurowski@cellcentric.com | |
| Karen Clegg, MD, MFPM | Contact | Karen.Clegg@cellcentric.com |
| Name | Affiliation | Role |
|---|---|---|
| Tim Somervaille | The Christie NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
At this stage, is not currently planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisations involved in the conduct of this study.
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The RP2D/MTD dose will be determined in Parts A and B. Parts C, D, E and F of the study may recruit patients concurrently.
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CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax |
|
| CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS | Experimental | CCS1477 monotherapy, CCS1477 combination with azacitidine |
|
| Pomalidomide | Drug | oral capsule |
|
| Dexamethasone | Drug | oral tablet |
|
| Azacitidine | Drug | Powder suspension for Injection |
|
| Venetoclax | Drug | Oral tablet |
|
| Bortezomib | Drug | Powder for solution for injection |
|
| Ixazomib | Drug | Oral capsule |
|
| Elranatamab | Drug | Solution for injection |
|
|
| Teclistamab | Drug | Solution for injection |
|
|
| Lenalidomide | Drug | Oral capsule |
|
| Daratumumab | Drug | Solution for injection, concentrate for solution for infusion |
|
Defined as the time from start of treatment until disease progression
| Up to 12 months |
| AUC of CCS1477 | Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477 | 35 days |
| Cmax of CCS1477 | Maximum observed plasma concentration (Cmax) of CCS1477 | 35 days |
| Community Health Network | Recruiting | Indianapolis | Indiana | 46227 | United States |
|
| The Center for Cancer and Blood Disorders (CCBD) | Recruiting | Bethesda | Maryland | 20817 | United States |
|
| Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68130 | United States |
|
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198-6846 | United States |
|
| Penn Medicine - Abramson Cancer Center Perelman | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Institute Bergonie | Completed | Bordeaux | 33076 | France |
| Gustave Roussy | Completed | Villejuif | 94805 | France |
| Hospital Germans Trias i Pujol/ ICO Badalona | Recruiting | Badalona | 08916 | Spain |
|
| University Hospital Vall D'Hebron | Completed | Barcelona | 08035 | Spain |
| Hospital ClÃnic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
|
| ICO L'Hospitalet (Instituto Catalán de OncologÃa) | Recruiting | Barcelona | 08908 | Spain |
|
| Hospital Universitario de La Princesa | Recruiting | Madrid | 28006 | Spain |
|
| Hospital Universitario Gregorio Marañón | Recruiting | Madrid | 28009 | Spain |
|
| Hospital Infanta Leonor | Recruiting | Madrid | 28031 | Spain |
|
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
|
| CIOCC Hospital Universitario HM Sanchinarro | Completed | Madrid | 28050 | Spain |
| Universidad de Navarra | Recruiting | Pamplona | 31008 | Spain |
|
| Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana | Recruiting | Valencia | 46026 | Spain |
|
| Karolinska Comprehensive Cancer Center | Completed | Stockholm | Sweden |
| The Royal Marsden | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
|
| The Clatterbridge Cancer Centre NHS Foundation Trust, | Recruiting | Bebington | CH63 4JY | United Kingdom |
|
| University Hospitals Bristol | Recruiting | Bristol | United Kingdom |
|
| University Hospital of Wales | Recruiting | Cardiff | United Kingdom |
|
| Royal Derby Hospital | Recruiting | Derby | DE22 3NE | United Kingdom |
|
| Western General Hospital | Recruiting | Edinburgh | EH4 2XU | United Kingdom |
|
| Gartnavel General Hospital | Recruiting | Glasgow | G12 0YN | United Kingdom |
|
| Leicester Royal Infirmary | Recruiting | Leicester | United Kingdom |
|
| St Bartholomew's Hospital | Recruiting | London | EC1A 7BE | United Kingdom |
|
| Sarah Cannon Research Institute UK | Recruiting | London | W1G 6AD | United Kingdom |
|
| NIHR University College London Clinical Research Facility | Recruiting | London | W1T 7HA | United Kingdom |
|
| Imperial College | Recruiting | London | United Kingdom |
|
| The Christie Hospital | Recruiting | Manchester | United Kingdom |
|
| Newcastle upon Tyne Hospitals | Recruiting | Newcastle upon Tyne | United Kingdom |
|
| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | NG5 1PB | United Kingdom |
|
| Cancer and Haematology Centre | Recruiting | Oxford | OX3 7LE | United Kingdom |
|
| University Hospital of Southampton | Recruiting | Southampton | SO16 6YD | United Kingdom |
|
| Royal Stoke University Hospital | Recruiting | Stoke-on-Trent | ST4 6QG | United Kingdom |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D016399 | Lymphoma, T-Cell |
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| ID | Term |
|---|---|
| C000721532 | CCS1477 |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| D001374 | Azacitidine |
| C579720 | venetoclax |
| D000069286 | Bortezomib |
| C548400 | ixazomib |
| D000077269 | Lenalidomide |
| C556306 | daratumumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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