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HMBD-001

Phase 1

Advanced or Metastatic Squamous Non-Small Cell Lung Cancer | Small molecule | Oncology |Merck KGaA|Trials Updated: May 27, 2026

HMBD-001 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment398

FDA Designations

No designations recorded

HMBD-001 clinical trials

HMBD-001 · 1 trial · 7 indications

Phase 1 1
NCT05910827A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell CancersAdvanced or Metastatic Squamous Non-Small Cell Lung Cancer
RECRUITING398 Analytics
PHASE1RECRUITING
A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
NCT05910827398
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Study Endpoints

Primary Endpoints

Incidence and Nature of Adverse Events (AEs)
From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment

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

Number of participants with dose-limiting toxicities (DLTs) - applicable to part A
From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days)

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

Six months progression-free survival (PFS) - applicable to part B
From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months

Number of participants achieving progression-free survival (PFS) at 6 months

Secondary Endpoints

Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1
From date of enrollment (first dosing) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
HMBD-001 serum concentration-time profile and derived PK parameters
From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months
HMBD-001 Immunogenicity Profile
From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALParticipants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment.
Arm BEXPERIMENTALParticipants receive HMBD-001 with docetaxel plus cetuximab. This treatment arm is closed to recruitment.
Arm CEXPERIMENTALParticipants receive HMBD-001 with cetuximab

Interventions

NameTypeDescription
HMBD-001DRUGHMBD-001 is a humanized Immunoglobulin G1 (IgG1) anti-Human Epidermal Growth Factor Receptor 3(HER3) monoclonal antibody (mAb). It is administered intravenously (IV) weekly
DocetaxelDRUGDocetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks
CetuximabDRUGCetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

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 ...

Countries:AustraliaMoldovaSingaporeSouth KoreaTaiwan
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