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A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers

ConditionsAdvanced or Metastatic Squamous Non-Small Cell Lung CancerAdvanced Head and Neck Squamous Cell CarcinomaAdvanced Esophageal Squamous Cell CarcinomaCervical Squamous Cell CarcinomaAdvanced Cutaneous Squamous Cell CarcinomaNasopharyngeal Cancinoma (NPC)Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHummingbird Bioscience

About this trial

This is a Phase Ib/II multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 of 0 to 1

Arm B only: 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

Disqualifiers

Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

398 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 3 interventions
Group C: Arm CExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and Nature of Adverse Events (AEs)

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

Time frame
From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment
2

Number of participants with dose-limiting toxicities (DLTs) - applicable to part A

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

Time frame
From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days)
3

Six months progression-free survival (PFS) - applicable to part B

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

Time frame
From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months

Secondary outcomes

1

Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1

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

Time frame
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
2

HMBD-001 serum concentration-time profile and derived PK parameters

Time frame
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
3

HMBD-001 Immunogenicity Profile

Number and percentage of participants who develop detectable ADAs

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hummingbird Bioscience

Lead sponsor

Merck KGaA, Darmstadt, Germany

Collaborator

Source ClinicalTrials.gov
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