Clinical Trials List
Protocol NumberHMBD-001-103
NCT Number(ClinicalTrials.gov Identfier)NCT05910827
Active
2024-10-25 - 2026-12-31
Phase I
Recruiting4
A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/04/22
Investigators and Locations
Co-Principal Investigator
- 莊政皓 Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsu-ching Huang Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
- 廖映庭 Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
- Yung-Hung Luo Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chun-Hui Lee
Co-Principal Investigator
- 黃怡菁 Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Seu-Chun Yang Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- 黃怡璇 Division of Hematology & Oncology
- 鍾秉軒 Division of Hematology & Oncology
- Chien-Chung Lin Division of General Internal Medicine
- Yu-Min Yeh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Objectives
The aim of this study is to determine whether the combination of HMBD-001 and cetuximab is safe and effective in treating advanced squamous cell carcinoma (SCC). The study also aims to determine whether the combination of HMBD-001 with cetuximab and docetaxel chemotherapy is safe and effective in treating advanced squamous non-small cell lung cancer (sqNSCLC).
Test Drug
注射液劑
注射液劑
注射劑
注射液
注射液劑
注射劑
注射液
Active Ingredient
1013000900
HMBD-001
1013000200
1013000220
HMBD-001
1013000200
1013000220
Dosage Form
27D
27D
270
279
27D
270
279
Dosage
500mg/100mL
500mg/10mL
20mg/1ml及80mg/4ml
20mg / 1ml 及 80mg / 4ml
500mg/10mL
20mg/1ml及80mg/4ml
20mg / 1ml 及 80mg / 4ml
Endpoints
Group B: Evaluate the safety and tolerability of HMBD-001 in combination with docetaxel and cetuximab in participants with advanced sqNSCLC.
Assess the preliminary antitumor activity of HMBD-001 in combination with docetaxel and cetuximab based on the objective response rate (ORR) in participants with advanced sqNSCLC.
Group C: Evaluate the safety and tolerability of HMBD-001 in combination with cetuximab in participants with advanced squamous cell carcinoma.
Assess the preliminary antitumor activity of HMBD-001 in combination with docetaxel and cetuximab based on the objective response rate (ORR) in participants with advanced sqNSCLC.
Group C: Evaluate the safety and tolerability of HMBD-001 in combination with cetuximab in participants with advanced squamous cell carcinoma.
Inclution Criteria
Inclusion Criteria:
Ability to understand and be willing to sign an informed consent form
Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is > 18 years of age)
Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable
Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,
Have an estimated life expectancy of at least 3 months
Participants must be willing to provide a fresh tumor biopsy sample
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
Ability to understand and be willing to sign an informed consent form
Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is > 18 years of age)
Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable
Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,
Have an estimated life expectancy of at least 3 months
Participants must be willing to provide a fresh tumor biopsy sample
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
Exclusion Criteria:
Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C
Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation
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
Treatment with strong inhibitors or inducers of CYP3A4
Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C
Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation
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
Treatment with strong inhibitors or inducers of CYP3A4
The Estimated Number of Participants
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Taiwan
7 participants
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Global
98 participants
