NCT05910827

Who might be able to join this trial:

• You must be able to understand and agree to sign a consent form to participate in the study
• You must be 18 years of age or older (or the age of majority in your country if that is higher than 18)
• You must be relatively active and able to care for yourself, with only mild limitations on daily activity (confirm with trial site what this means for you specifically)
• If joining Arm B: You must have locally advanced or spreading squamous non-small cell lung cancer where all standard treatment options have been tried or declined, and at least one measurable tumour
• If joining Arm C: You must have advanced or spreading squamous cancers of the lung, head and neck, food pipe, skin, cervix, nasopharynx, or other squamous cancers, and have had at least one previous systemic treatment
• Your doctors must estimate that you are likely to live for at least 3 more months
• You must be willing to provide a fresh tumour tissue sample (biopsy)
• Your liver, kidneys, and other organs must be working well enough (confirm with trial site)
• Women must not be pregnant or breastfeeding and must use highly effective contraception, or be surgically unable to have children, or be post-menopausal
• Men must use highly effective contraception or be surgically unable to father children, or abstain from sex with women who could become pregnant, throughout the study

Who may not be able to join:

• You have previously been treated with HMBD-001, docetaxel (except in Arm C), cetuximab, or any drug that targets EGFR or HER3 receptors, including combined HER-targeting drugs
• You have previously received targeted therapy for specific gene mutations or changes linked to lung or other cancers (confirm with trial site for the full list)
• You are still experiencing significant side effects (grade 2 or higher) from previous cancer treatments, unless those side effects are considered unlikely to affect your safety or the study results (such as hair loss)
• Your most recent cancer treatment, including radiotherapy, was less than 4 weeks ago (or less than 6 weeks ago for certain chemotherapy drugs, or less than 5 half-lives of the drug — whichever is shorter)
• You have cancer in your brain or spinal cord that is causing active symptoms, unless those symptoms have been stable for at least 28 days before starting the study drug
• You have abnormal heart function
• You have a history of serious uncontrolled allergic reactions, or are known to be allergic to the study drugs you would be given
• You have another active cancer, other than certain treated skin conditions or early-stage cervical cell changes
• You have any other serious uncontrolled illness or condition requiring ongoing treatment
• You have a known HIV infection
• You have an active hepatitis B or hepatitis C infection
• You are pregnant or breastfeeding
• You have had a COVID-19 infection within the past 3 months before starting the study drug
• You have received a COVID-19 vaccine within 14 days before starting the study drug
• You are taking certain medicines that strongly affect how a specific liver enzyme (CYP3A4) works (confirm with trial site which medicines this includes)

Important: Always verify eligibility with the trial site directly before applying.