Safety and Activity of HF50 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- HF50
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov