Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05919537
Other study ID # HMBD-001-102
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 6, 2023
Est. completion date March 1, 2031

Study information

Verified date January 2024
Source Hummingbird Bioscience
Contact Kon Yew Kwek, BMBCh, DPhil
Phone +6569795574
Email k.y.kwek@hummingbirdbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 1b multi-center, open-label study of HMBD-001 with or without chemotherapy in participants with advanced solid tumors harboring NRG1 gene fusions or selected HER3 mutations.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date March 1, 2031
Est. primary completion date March 1, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ability to understand and be willing to sign an informed consent form - Males and females aged over 18 years - Eastern Cooperative Oncology Group (ECOG) status of 0 to 1 - Histologic or cytologic evidence of an advanced malignant 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: Cancer harboring an NRG1 gene fusion with EGF-like domain; Arm A: Participants with locally advanced or metastatic pancreatic adenocarcinoma 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 tumour sample available or have a site of disease amenable to biopsy 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 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 Exclusion Criteria: - Prior treatment with HMBD-001, pertuzumab, or an agent that specifically targets HER3, including pan-HER tyrosine kinase inhibitors - Persistent clinically significant toxicities (Grade =2) from previous anti-cancer therapy except for Grade >2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the study results e.g., alopecia - Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment - Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline - Evidence of abnormal cardiac function - History of uncontrolled allergic reactions and/or known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into - Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer - Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment - Known Human Immunodeficiency Virus (HIV) infection - Active hepatitis B or hepatitis C infection - Pregnant or breast feeding - COVID 19 infection within 3 months prior to the first dose of the study drug - COVID 19 vaccination within 14 days prior to the first dose of the study drug

Study Design


Intervention

Drug:
HMBD-001
HMBD-001 is a humanized IgG1 anti-HER3 monoclonal antibody (mAb). It is administered IV weekly
Docetaxel
Docetaxel 75 mg/m^2 IV once every 3 weeks
Nab-paclitaxel
Nab-paclitaxel 125 mg/m^2 IV on days 1, 8, 15, every 4 weeks
Gemcitabine
Gemcitabine 1000 mg/m^2 IV on days 1, 8, 15, every 4 weeks

Locations

Country Name City State
Australia Southern Oncology Clinical Research Unit Adelaide South Australia
Australia ICON Cancer Centre South Brisbane Brisbane Queensland
Australia Cabrini Health Malvern Victoria
Australia Linear Clinical Research Perth Western Australia
Australia GenesisCare North Shore Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Hummingbird Bioscience

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and Nature of Adverse Events (AEs) An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered to be related to the study treatment. From the time the ICF is signed until 30 days after last dose of study treatment
Primary Arm A and B only: Incidence and nature of dose-limiting toxicities (DLTs) during the first cycle of treatment DLTs will be assessed during the safety run-in phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (4 weeks for Arm A, 3 weeks for Arm B) of treatment Arm A: During the first four weeks of study treatment Arm B: During the first three weeks of study treatment
Primary Objective Response Rate (ORR) by RECIST V1.1 The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1 Up to 24 months
See also
  Status Clinical Trial Phase
Terminated NCT03087448 - Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT05042375 - A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 3
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT05009836 - Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03219970 - Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Recruiting NCT05949619 - A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT04054531 - Study of KN046 With Chemotherapy in First Line Advanced NSCLC Phase 2
Withdrawn NCT03519958 - Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Terminated NCT02580708 - Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer Phase 1/Phase 2
Completed NCT01871805 - A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Terminated NCT04042480 - A Study of SGN-CD228A in Advanced Solid Tumors Phase 1
Recruiting NCT05919641 - LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
Completed NCT03656705 - CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma Phase 1
Completed NCT02777567 - KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)