A Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors

Inclusion Criteria

• •Body weight ≥ 40 kg.
• •Willing and able to provide signed written informed consent before any study-related screening procedures are performed.
• •Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractory to or ineligible for standard therapy, or for whom no standard therapy is available; or the patient has documented their refusal of standard of care therapies. These include the following:
• •1. Unresectable or metastatic cutaneous melanoma (HER3+)
• •2. Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
• •3. Unresectable, locally advanced or metastatic breast cancer
• •4. Relapsed or refractory solid tumors, with documented HER3+ expression such as Pancreatic Ductal Adenocarcinoma (PDAC) and gastric cancers, may be allowed in the protocol following sponsor approval on a case-by -case basis.
• •If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for retrospective assessment of HER3+ status following enrollment..
• •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
• •Contraceptive requirements:
• •1. Women of childbearing potential (WOCBP) must use contraception from at least 28 days prior to study start, during the study, and for at least 6 months after the last dose of study drug.
• •2. Males who are sexually active with partner(s) who are WOCBP must agree to use a male condom with spermicide beginning at study start, during the study and for at least 6 months after the last dose of study drug.
• •Females must:
• •1. Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug.
• •2. Agree to not breastfeed and do not plan to become pregnant during the study and for at least 6 months after the last dose of study drug.
• •Males must:
• •1. Agree to not donate sperm beginning at study start, during the study, and for at least 6 months after the last dose of study drug.
• •2. Agree to not plan to father a child beginning at study start, during the study, and for at least 6 months after last dose of study drug.
• •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.