Brief Summary
This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HMBD-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dosethe amount of medication taken escalation phase (Phase 1) and a dose expansion phase (Phase 2).
The primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of increasing doses of HMBD-501 in patients with advanced-stage solid tumors and identify the recommended Phase 2 dose (RP2D) of ENV-501. During Phase 1, successive cohorts of patients will receive escalating doses of HMBD-501. The results of the dose escalation will determine the RP2D and dosing schedule of HMBD-501 to be administered in the Phase 2 part of the study. The primary objective of Phase 2 is to evaluate the preliminary clinical efficacy of HMBD-501 in dose expansion cohorts.
Intervention / Treatment
- Biological: ENV-501
Inclusion Criteria
- Body weight ≥ 40 kg.
- Willing and able to provide signed written 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. before any study-related screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening procedures are performed.
- Patients with histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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:
- Unresectable or metastatic cutaneous melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) (HER3+)
- Locally advancedat a late stage, far along or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)
- Unresectable, locally advanced or metastatic breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs
- Relapsed or refractory solid tumors, with documented HER3+ expression such as Pancreatic Ductal Adenocarcinomacancer arising from mucus-producing glands in organs (PDAC) and gastric cancers, may be allowed in the protocol following sponsor approval on a case-by -case basis.
- If molecular pathologythe study of disease report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsyremoval of a section of tissue to analyse for cancer cells for retrospective assessment of HER3+ status following enrollment..
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (PS) 0-2.
- Contraceptive requirements:
- 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.
- 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:
- 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.
- 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:
- 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.
- 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.