Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tum… (NCT05919537) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
Australia68 participantsStarted 2023-09-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 o…
What they're measuring
1
Incidence and Nature of Adverse Events (AEs)
Timeframe: From the time the ICF is signed until 30 days after last dose of study treatment
2
Arm A and B only: Incidence and nature of dose-limiting toxicities (DLTs) during the first cycle of treatment
Timeframe: Arm A: During the first four weeks of study treatment Arm B: During the first three weeks of study treatment