HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHighField Biopharmaceuticals Corporation
About this trial
This is an open-label, single-arm, non-randomized, single-center, dose-escalation study designed to evaluate the safety and tolerability of HF50 in patients with HER-2 positive and HER-2 low-expression advanced solid tumors. The primary objectives are to assess the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HF50. Secondary objectives include evaluating the pharmacokinetic (PK) profile and preliminary antitumor activity of HF50.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must voluntarily provide written informed consent (ICF) prior to any study-related procedures, and be capable of complying with all protocol requirements.
Adult participants aged between 18 and 75 years (inclusive) at the time of ICF signing.
Histologically or cytologically confirmed advanced HER-2 positive or HER-2 low-expression solid tumors that are unresectable, metastatic, or have relapsed after standard therapies, are intolerant to standard therapies (e.g., chemotherapy, targeted therapy), or lack effective treatment options.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
History of active autoimmune disease or autoimmune disease considered unsuitable for study participation, with exceptions for localized skin conditions (e.g., eczema involving <10% of body surface area, vitiligo, psoriasis, alopecia) or childhood asthma resolved without treatment in adulthood.
Current use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 4 weeks prior to the first dose, except for local steroid use.
Receipt of systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy less than 2 weeks (or 4 weeks for nitrosourea or mitomycin C) or within 5 half-lives of the prior therapy before the first dose.
Symptomatic brain metastases or leptomeningeal disease unless adequately treated (e.g., surgery or radiotherapy) with no evidence of progression for ≥28 days and off systemic steroids for ≥14 days prior to the first dose.
Trial design
Design model
Single group
Treatments tested in this trial
HF50
DrugHF50 is a liposomal T-cell engager with an unique design based on the lipid bilayer. It was also named a T cell Redirecting Antibody Fragment-anchored Liposomes (TRAFsome). The liposomal surface carries anti-CD3ε and anti-HER2 antibody-conjugated lipid molecules, enabling T-cell redirection and activation at HER2-positive or HER2-low tumor sites. In addition, the liposome internal space contains a TLR7/8 agonist Resiquimod (R848), which has been shown to help modulate the myeloid cells in the tumor micro-environement to complement the immune activation effects.
Treatment groups
10 Participants
are divided into 4 treatment groupsGroup A: Dose Level 1 - 1 mgExperimental treatment 1 intervention
Group B: Dose Level 2 - 10 mgExperimental treatment 1 intervention
Group C: Dose Level 3 - 60 mgExperimental treatment 1 intervention
Group D: Dose Level 4 - 240 mgExperimental 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
Incidence of Serious Adverse Events (SAEs)
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.4
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
Pharmacokinetic Parameter - Cmax
Maximum plasma concentration (Cmax) of HF50 will be assessed following single and multiple dosing.
Time frame
Up to 9 weeks2
Pharmacokinetic Parameter - Tmax
Time to maximum plasma concentration (Tmax) of HF50 will be assessed following single and multiple dosing.
Time frame
Up to 9 weeks3
Pharmacokinetic Parameter - AUC (Area Under the Curve)
AUC0-t and AUC0-inf will be evaluated to determine systemic exposure to HF50.
Time frame
Up to 9 weeks4
Pharmacokinetic Parameter - Half-life (t1/2)
The terminal elimination half-life (t1/2) of HF50 will be calculated.
Time frame
Up to 9 weeksSponsors and contacts
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Source ClinicalTrials.gov