Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation

Intervention / Treatment 

Inclusion Criteria:

• Ability to understand and be willing to sign an informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. form
  • Males and females aged over 18 years
  • Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) status of 0 to 1
  • Histologic or cytologic evidence of an advanced malignantcancerous, may grow and spread to other areas of the body solid that is resistant/refractory to standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the physician’s judgment likely to result in clinical benefit, or the participant has demonstrated to be intolerable to such therapy, or if such therapy has been refused by the participant
  • Arms A, B and C: Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs harboring an NRG1 gene fusion with EGF-like domain; Arm A: Participants with locally advanced or metastatic pancreatic adenocarcinomacancer arising from mucus-producing glands in organs that have not received prior treatment with gemcitabine or nab-paclitaxel and /or have not received more than 2 lines of systemic therapy for advanced disease; Arm B: Participants with locally advanced or metastatic non-small cell lung cancer that have not received prior treatment with docetaxel and /or have not received more than 2 lines of systemic therapy for advanced disease; Arm C: Participants must not be eligible to participate in Arm A or B
  • Arm D: Cancer harboring selected HER3 mutations limited to the extracellular domain.
  • Have an estimated life expectancy of at least 3 months
  • Have an archival tumoura tissue mass that forms from groups of unhealthy cells sample available or have a site of disease amenable to biopsyremoval of a section of tissue to analyse for cancer cells and be willing to undergo a biopsy prior to the receipt of the assigned study treatment
  • Have adequate organ function
  • Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.