Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing to take part and sign a consent form agreeing to participate
• People aged 18 or older, of any gender
• People who have been diagnosed with a solid tumour cancer that has spread to nearby tissue or to other parts of the body, confirmed through laboratory testing of tissue or cell samples
• People who have at least one tumour that can be tracked and measured using standard imaging criteria (the specific requirements differ slightly between the two parts of the trial — confirm with the trial site which part would apply)
• People whose cancer has continued to grow or spread during or after at least one previous standard cancer treatment, and for whom no suitable standard treatment remains available (Part 2 of the trial is specifically for people with non-small cell lung cancer, liver cancer, head and neck squamous cell carcinoma, or colorectal cancer)
• People who are generally able to carry out basic daily activities with no or minimal limitations, based on a standard medical performance scale (ECOG score of 0 or 1)
• People whose life expectancy is at least 12 weeks
• People whose liver, kidneys, bone marrow, and other organs are functioning well enough to meet the trial's safety requirements
• People who can provide either a stored tumour tissue sample taken within the last 5 years, or a fresh tissue sample taken by biopsy before starting the trial

Who may not be able to join:

• People who have been diagnosed with a second, separate cancer that was active within the past 2 years (some exceptions may apply for certain low-risk cancers that are considered fully treated — the trial doctors would assess this)
• People who have had cancer spread to the brain or spinal cord that is currently causing symptoms, or that requires radiation, surgery, or steroid medications to manage, within 2 weeks before starting the trial
• People with a history of non-infectious lung inflammation that required steroid treatment, or who currently have or are suspected to have lung inflammation
• People who have fluid build-up around the lungs, heart, or abdomen that is not under control, or that has needed draining or medical treatment within the 4 weeks before starting the trial
• People who have not yet recovered from side effects caused by previous cancer treatments (recovery is generally defined as returning to a mild or baseline level)
• People currently taking part in another clinical trial involving an experimental drug or medical device, or who have done so within 4 weeks before starting this trial
• People who have received certain recent cancer treatments before starting the trial, including: chemotherapy within 3 weeks; targeted small-molecule cancer drugs within 2 weeks; cancer immunotherapy antibodies, antibody-drug conjugates, or other biological cancer treatments within 4 weeks or 5 half-lives of the drug (whichever is shorter); herbal or traditional Chinese medicines used for cancer treatment within 2 weeks; or radiotherapy within 4 weeks
• People who have previously been treated with a specific type of antibody-drug conjugate (one containing a topoisomerase I inhibitor), or with an antibody-drug conjugate that targets certain proteins called EGFR or cMET
• People who have received a live vaccine within 4 weeks before starting the trial
• People who have taken certain medications within 14 days before starting the trial, including drugs that strongly affect how the body processes other medicines (CYP3A4 inducers or inhibitors), or drugs known to affect heart rhythm in a potentially dangerous way
• People who have HIV infection or AIDS
• People who have had a significant heart or cardiovascular health event within the 6 months before starting the trial, including heart attack, severe chest pain, stroke, certain types of heart failure, or a heart condition requiring ongoing medication
• People who have had an organ transplant from another person, or who have experienced graft-versus-host disease
• People with a known allergy or sensitivity to the trial drug (SIM0610) or to similar types of drugs
• Women who are pregnant or breastfeeding; women who could become pregnant are also excluded unless a pregnancy test taken within 72 hours before starting the trial is negative and they use highly effective contraception from the time of signing the consent form until 180 days after the last dose
• Men whose partners could become pregnant, unless they use highly effective contraception from the time of signing the consent form until 180 days after the last dose
• People who have any other medical condition or circumstance that the trial doctors believe could increase health risks or affect the reliability of the trial results

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