Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMBD-001 · 1 trial · 7 indications
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, vital signs and ECG results per NCI CTCAE V5.0 Incidence of dose interruptions and modifications An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered to be related to the study treatment
DLTs will be assessed in the dose escalation cohorts and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3 weeks) of treatment
Number of participants achieving progression-free survival (PFS) at 6 months
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Participants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment. |
| Arm B | EXPERIMENTAL | Participants receive HMBD-001 with docetaxel plus cetuximab. This treatment arm is closed to recruitment. |
| Arm C | EXPERIMENTAL | Participants receive HMBD-001 with cetuximab |
| Name | Type | Description |
|---|---|---|
| HMBD-001 | DRUG | HMBD-001 is a humanized Immunoglobulin G1 (IgG1) anti-Human Epidermal Growth Factor Receptor 3(HER3) monoclonal antibody (mAb). It is administered intravenously (IV) weekly |
| Docetaxel | DRUG | Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks |
| Cetuximab | DRUG | Cetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1 |
Inclusion Criteria: * Ability to understand and be willing to sign an informed consent form * Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is \> 18 years of age) * Eastern Cooperative Oncology Group (ECOG) status ...
HMBD-001 is an investigational small molecule being studied for the treatment of advanced or metastatic squamous non-small cell lung cancer. It is currently in Phase 1 clinical development, and its safety and efficacy have not yet been established. The drug is not approved by regulatory authorities.
HMBD-001 is an anti-HER3 antibody, meaning it targets the HER3 receptor. It is being evaluated in combination with cetuximab, with or without docetaxel, in patients with advanced squamous cell cancers, including squamous non-small cell lung cancer. The drug is designed to interfere with HER3 signaling in tumor cells.
HMBD-001 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials and is not yet approved for commercial use.
HMBD-001 is in Phase 1 clinical development. It is being studied in an ongoing Phase Ib/II trial, but the drug is still investigational and has not received FDA approval. The trial is currently recruiting participants.
HMBD-001 is being evaluated in clinical trial NCT05910827, a Phase Ib/II study of HMBD-001 with cetuximab, with or without docetaxel, in advanced squamous cell cancers. The trial is recruiting and aims to enroll 398 participants across Australia, Moldova, Singapore, South Korea, and Taiwan.
Yes, HMBD-001 is an anti-HER3 antibody. It is being studied in combination with other therapies for the treatment of advanced squamous cell cancers, including squamous non-small cell lung cancer. The drug is in Phase 1 clinical development and is not yet approved.