A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours (NCT05057013) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours
United Kingdom81 participantsStarted 2021-11-10
Plain-language summary
This clinical trial is evaluating a drug called HMBD-001 (an anti-HER3 monoclonal antibody) in participants with advanced HER3 positive solid tumours. The main aims are to find out the best dose of HMBD-001 that can be given to participants alone and in combination with other anti-cancer agents, more about the potential side effects of HMBD-001 and how they can be treated, and what happens to HMBD-001 inside the body and how it affects cancer cells.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Written (signed and dated) informed consent and be capable of co-operating with HMBD-001 administration and follow-up.
✓. Part A: Monotherapy Dose Escalation
✓. Life expectancy of at least 12 weeks.
✓. Eastern Cooperative Oncology Group performance status of 0 or 1.
✓. Haematological and biochemical indices within the protocol specified ranges.
✓. Participants with advanced prostate cancer must have castrate levels of testosterone and have received a next generation hormonal agent (at least one of abiraterone, enzalutamide, apalutamide or darolutamide).
✓. Part A: Aged 16 years or over at the time consent is given.
✓. Part B Arm 1: Aged 18 years or over at the time consent is given.
Exclusion criteria
✕. Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy (with the exception of life-long hormone suppression such as luteinising hormone-releasing hormone agents in prostate cancer), immunotherapy or investigational medicinal products during the previous 4 weeks before first dose of HMBD-001 or enzalutamide, as applicable.
✕. Participants with ongoing toxic manifestations of previous treatments greater than NCI CTCAE Grade 1. Exceptions apply.
✕. Participants with symptomatic brain or leptomeningeal metastases should be excluded. Exceptions apply.
What they're measuring
1
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs); Part A
Timeframe: From first dose onwards until completion of Cycle 1 (28 days)
2
Number of Participants Who Experienced DLTs; Part B Arm 1
Timeframe: From first dose of combination therapy onwards until completion of Cycle 1 (28 days)
3
Number of adverse events (AEs) by arm considered to be at least possibly related to HMBD-001 (Part A and Part B Arm 1)
Timeframe: From the date of written informed consent until the end of the safety follow-up period (maximum [max] 42 weeks per participant)
4
Number of Grade 3, 4 and 5 AEs by arm considered to be at least possibly related to HMBD-001 (Part A and Part B Arm 1)
Timeframe: From the date of written informed consent until the end of the safety follow-up period (max 42 weeks per participant)
5
Overall response rate (ORR) within 6 cycles of HMBD-001 (Part B Arm 1)
Timeframe: From baseline radiological disease assessment until 28 days after last dose of HMBD-001 (max 36 weeks per participant)
✕. Women of child-bearing potential (or are already pregnant or lactating). Exceptions apply.
✕. Male participants with partners of child-bearing potential. Exceptions apply.
✕. Major surgery from which the participant has not yet recovered.
✕. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
✕. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus infection. Participants with previous hepatitis C exposure but no current infection are eligible to participate.