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RecruitingLast updated: 5 April 2024

Hummingbird: This study is evaluating the effectiveness of a new targeted therapy (called HMBD-001) in combination with chemotherapy, with or without additional targeted therapy, in people with advanced squamous non-small cell lung cancersA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two experimental treatment arms.

In Arm A, participants will receive the study drug (called HMBD-001) plus chemotherapy (called docetaxel). HMBD-001 will be administered intravenously weekly. Docetaxel will be administered intravenously at a dose of 75mg/m^2 once every 3 weeks.

In Arm B, participants will receive the study drug (HMBD-001) plus chemotherapy (docetaxel) and targeted therpapy (called cetuximab). HMDB-001 will be administered intravenously weekly. Docetaxel will be administered intravenously at a dose of 75mg/m^2 once every 3 weeks. Cetuximab will be administered intravenously, first at a loading dose of 400mg/m^2, followed by 250mg/m^2 weekly.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I/II

Trial Acronym

Hummingbird

More information

Trial Identifiers

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Trial sponsor

Hummingbird Bioscience

Scientific 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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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