Clinical Trials

Several Phase 1 clinical trials sponsored by Hoffmann-La Roche have evaluated the safety, pharmacokinetics, and clinical activity of the BET inhibitor TEN-010 (RO6870810) across diverse oncological indications. These early-phase studies investigated solid tumors—such as advanced ovarian cancer and triple-negative breast cancer—and hematological malignancies, including diffuse large B-cell lymphoma, acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma. Incorporating both completed and terminated study protocols, these trials aimed to characterize the therapeutic potential of targeted BET inhibition in patients with advanced neoplasms.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03292172 Terminated
Advanced Ovarian Cancer|Triple Negative Breast Cancer
Hoffmann-La Roche
 2017-11-08 Phase 1
NCT03255096 Completed
Diffuse Large B-cell Lymphoma|High-Grade B-cell Lymphoma
Hoffmann-La Roche
 2017-08-28 Phase 1
NCT03068351 Completed
Multiple Myeloma
Hoffmann-La Roche
 2017-06-26 Phase 1
NCT02308761 Completed
Acute Myeloid Leukemia|Myelodysplastic Syndromes
Hoffmann-La Roche
 2014-11-06 Phase 1
NCT01987362 Completed
Solid Tumors Advanced Solid Tumors
Hoffmann-La Roche
 2013-10-16 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the TEN-010 ((S)-JQ-35) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TEN-010 selectively binds to the acetyl-lysine binding pockets of Bromodomain and Extra-Terminal (BET) family proteins, thereby disrupting the recruitment of transcriptional machinery to acetylated chromatin and suppressing the expression of key oncogenic driver genes. This transcriptional inhibition halts cell cycle progression and triggers apoptosis, providing a mechanistic rationale for its investigation in clinical trials targeting advanced hematological malignancies and solid tumors.

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>).

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Note: Technical data last updated: Sep 1, 2026.