CellCentric Ltd. sponsors multiple clinical trials evaluating inobrodib (CCS-1477) across Phase 1, Phase 2, and Phase 3 studies, encompassing both completed and actively recruiting statuses. Early-to-mid phase trials assess inobrodib as monotherapy or combination therapy for advanced solid tumors—including metastatic castration-resistant prostate cancer, metastatic breast cancer, and non-small cell lung cancer—and hematological malignancies such as acute myeloid leukemia, non-Hodgkin lymphoma, and peripheral T-cell lymphoma. Additionally, ongoing late-phase clinical trials focus on recruiting patients with relapsed or refractory multiple myeloma to evaluate therapeutic combination regimens.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07096778 | RECRUITING | Multiple Myeloma Refractory; Multiple Myeloma in Relapse |
CellCentric Ltd. |
2026-01-22 | PHASE2 |
| NCT07772024 | RECRUITING | Multiple Myeloma Refractory; Multiple Myeloma in Relapse |
CellCentric Ltd. |
2026-08 | PHASE3 |
| NCT04068597 | RECRUITING | Haematological Malignancy; Acute Myeloid Leukemia; Non Hodgkin Lymphoma; Multiple Myeloma; Higher-risk Myelodysplastic Syndrome; Peripheral T Cell Lymphoma |
CellCentric Ltd. |
2019-08-09 | PHASE1; PHASE2 |
| NCT03568656 | COMPLETED | Metastatic Castration-Resistant Prostate Cancer; Metastatic Breast Cancer; Non-small Cell Lung Cancer; Advanced Solid Tumors |
CellCentric Ltd. |
2018-07-23 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-30)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Inobrodib (CCS-1477) Mechanism of Action: p300/CBP Inhibition in Plasma Cell Research
- Inobrodib (CCS-1477): Selectivity & Specificity
- Inobrodib (CCS-1477) Working Concentration | Cell Culture | Treatment
- Inobrodib (CCS-1477) Solubility in DMSO
- Inobrodib (CCS-1477) Stock Solution
- Inobrodib (CCS-1477) Storage
- Inobrodib (CCS-1477) Stability
- Inobrodib (CCS-1477) Combination Database
- Inobrodib (CCS-1477) Molecular Weight
- Inobrodib (CCS-1477) SMILES
- Inobrodib (CCS-1477) CAS Number
- Inobrodib (CCS-1477) Chemical Structure (2D and 3D)
- Inobrodib (CCS-1477) IC50 for Cell-based and Cell-free Assays
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- Inobrodib (CCS-1477) SDS｜MSDS