Safety and Activity of HF50 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHighField Biopharmaceuticals Corporation
About this trial
A study to assess the safety, tolerability, and pharmacokinetics of HF50 in participants with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation: Capable of giving signed informed consent and able to comply with all study-related procedures.
Age: Adults >= 18 years of age at the time of signing informed consent; male or female.
Disease Status: Participants with histologically or cytologically confirmed advanced solid tumors that are unresectable or metastatic, who have failed or are intolerant to standard therapies, or for whom no effective therapy currently exists. Examples include HER2-expressing gynecological tumors and recurrent ovarian clear cell carcinoma after failure of platinum-based chemotherapy.
Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Disqualifiers
Autoimmune Disease: Any active autoimmune disease or history of autoimmune disease deemed unsuitable by the investigator. Exceptions include skin conditions not requiring systemic treatment (e.g., eczema < 10% of body surface area, vitiligo, psoriasis, alopecia) and resolved childhood asthma.
Corticosteroids/Immunosuppressants: Current use of immunosuppressants or systemic corticosteroids (> 10 mg/day prednisone or equivalent) within 4 weeks prior to the first dose. Topical steroid use is permitted.
Prior Anti-tumor Therapy: Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 2 weeks prior to dosing (4 weeks for nitrosoureas or mitomycin C); or other therapies (endocrine therapy, TCM, localized palliative radiotherapy) within 2 weeks.
CNS Metastasis: Clinically symptomatic brain or meningeal metastases. Participants with treated brain metastases are eligible if radiographic stability is maintained for >= 28 days, systemic steroids have been discontinued for > 14 days, and the participant is asymptomatic.
Trial design
Design model
Single group
Treatments tested in this trial
HF50
DrugHF50 is an innovative liposome-encapsulated bifunctional therapeutic designed to redirect T-cells to HER2-expressing tumor cells while simultaneously activating innate immunity through TLR7/8 agonism.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: HF50Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Dose Limiting Toxicities (DLT)
The number of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period to determine the maximum tolerated dose (MTD).
Time frame
28 days after the first dose (C1D1) for each dose cohort.2
Incidence of Adverse Events (AEs)
The number and percentage of participants experiencing adverse events (AEs), graded according to NCI-CTCAE v5.0
Time frame
From first dose to 28 days after the last dose.3
Recommended Phase II Dose (RP2D) of HF50
RP2D will be determined based on safety, tolerability, and pharmacokinetics data collected during the dose escalation phase.
Time frame
At the end of dose escalation (assessed up to 1 year)Secondary outcomes
1
Objective Response Rate (ORR)
Proportion of participants achieving a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria.
Time frame
Up to 2 years2
Duration of Response (DOR)
Time from the first documented response (CR or PR) to disease progression or death.
Time frame
Up to 2 years3
Disease Control Rate (DCR)
Proportion of participants achieving CR, PR, or stable disease (SD) based on RECIST v1.1.
Time frame
Up to 2 years4
Progression-Free Survival (PFS)
Time from the first dose to disease progression or death.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov