Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers

Hummingbird Bioscience (Industry)
Overall Status
Not yet recruiting ID
Merck KGaA, Darmstadt, Germany (Industry)

Study Details

Study Description

Brief Summary

This is a phase 1b multi-center, open-label study of HMBD-001 in combination with docetaxel with or without cetuximab in participants with locally advanced or metastatic squamous Non-Small Cell Lung Cancers

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Anticipated Enrollment :
62 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Phase 1b Study to Evaluate HMBD-001 in Combination With Docetaxel With or Without Cetuximab in Participants With Advanced Squamous Non-small Cell Lung Cancers
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

All participants receive HMBD-001 with docetaxel

Drug: HMBD-001
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

Drug: Docetaxel
Docetaxel 75 mg/m^2 IV once every 3 weeks

Experimental: Arm B

All participants receive HMBD-001 with docetaxel plus cetuximab

Drug: HMBD-001
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

Drug: Docetaxel
Docetaxel 75 mg/m^2 IV once every 3 weeks

Drug: Cetuximab
Cetuximab 400 mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly

Outcome Measures

Primary Outcome Measures

  1. 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]

    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

  2. Number of participants with dose-limiting toxicities (DLTs) [During the first three weeks of study treatment]

    DLTs will be assessed during the safety run-in phase 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

  3. Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 [Up to 24 months]

    The ORR is defined as the proportion of subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), based on RECIST Version 1.1

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Ability to understand and be willing to sign an informed consent form

  • Males and females aged over 18 years

  • Eastern Cooperative Oncology Group (ECOG) status of 0 to 1

  • Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable

  • Tumor has known wild type status for selected genes

  • Have an estimated life expectancy of at least 3 months

  • Participants must be willing to provide a fresh tumor biopsy sample

  • Have adequate organ function

  • Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal

  • Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion

Exclusion Criteria:
  • Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors

  • Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation

  • Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade >2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the study results e.g., alopecia

  • Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment

  • Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline

  • Evidence of abnormal cardiac function

  • History of uncontrolled allergic reactions and/or known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into

  • Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer

  • Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment

  • Known Human Immunodeficiency Virus (HIV) infection

  • Active hepatitis B or hepatitis C infection

  • Pregnant or breast feeding

  • COVID 19 infection within 3 months prior to the first dose of the study drug

  • COVID 19 vaccination within 14 days prior to the first dose of the study drug

  • Treatment with strong inhibitors or inducers of CYP3A4

Contacts and Locations


Site City State Country Postal Code
1 GenesisCare North Shore Sydney New South Wales Australia 2065

Sponsors and Collaborators

  • Hummingbird Bioscience
  • Merck KGaA, Darmstadt, Germany


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Hummingbird Bioscience Identifier:
Other Study ID Numbers:
  • HMBD-001-103
First Posted:
Jun 20, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Hummingbird Bioscience
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023