RecruitingPhase 1

HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors

United States, China84 participantsStarted 2023-12-12

Plain-language summary

HF158K1 is an investigational liposome form of doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, encapsulated by lipid membranes containing TL01, a HER2-directed Trastuzumab Fab fragment conjugated lipid.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntary to participate and sign ICF.
. Age ≥ 18 and ≤ 75 years.
. Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+).
. ECOG score 0-1.
. Expected survival ≥ 6 months.
. At least one measurable lesion per RECIST v1.1.
. Adequate organ function: ANC ≥ 1.5×10⁹/L, LYM ≥ 1.0×10⁹/L, PLT ≥ 90×10⁹/L, HGB ≥ 8.0 g/dL; APTT ≤ 1.5×ULN, INR ≤ 1.5; TBIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN (≤ 5×ULN if liver metastases); CrCl ≥ 30 mL/min; LVEF ≥ 50%.
. Agreement to use effective contraception.

Exclusion criteria

. Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity.
. Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone).
. Prior anti-tumor therapy \< 2 weeks (4 weeks for nitrosourea/mitomycin C).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Events

Timeframe: The period of AE collection starts after the participant receives the investigational drug, until 28±3 days after the EOT/early withdrawal or before the participant starts another anti-tumor treatment (whichever occurs first).

Incidence of dose-limiting toxicities(DLT)

Timeframe: The DLT evaluation period is from the first administration of the investigational drug to the end of the first treatment cycle, lasting for 21 days.（only Ia）

Red blood cell count in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)

White blood cell in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)

Hematocrit in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)

Neutrophil count in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)

Trial details

NCT IDNCT05861895

SponsorHighField Biopharmaceuticals Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-23

View on ClinicalTrials.gov More Solid Tumors, Adult trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntary to participate and sign ICF.
. Age ≥ 18 and ≤ 75 years.
. Unresectable or metastatic advanced solid tumors with HER-2 expression (IHC 3+, 2+, or 1+).
. ECOG score 0-1.
. Expected survival ≥ 6 months.
. At least one measurable lesion per RECIST v1.1.
. Adequate organ function: ANC ≥ 1.5×10⁹/L, LYM ≥ 1.0×10⁹/L, PLT ≥ 90×10⁹/L, HGB ≥ 8.0 g/dL; APTT ≤ 1.5×ULN, INR ≤ 1.5; TBIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN (≤ 5×ULN if liver metastases); CrCl ≥ 30 mL/min; LVEF ≥ 50%.
. Agreement to use effective contraception.

Exclusion criteria

. Cumulative doxorubicin dose ≥ 350 mg/m² or prior anthracycline-induced cardiotoxicity.
. Current use of immunosuppressants or systemic corticosteroids (\> 10 mg/day prednisone).
. Prior anti-tumor therapy \< 2 weeks (4 weeks for nitrosourea/mitomycin C).

What they're measuring

Incidence of Adverse Events

Incidence of dose-limiting toxicities(DLT)

Timeframe: The DLT evaluation period is from the first administration of the investigational drug to the end of the first treatment cycle, lasting for 21 days.（only Ia）

Red blood cell count in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)

White blood cell in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)

Hematocrit in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)

Neutrophil count in whole blood sample

Timeframe: Baseline, Day 1 of each 21-day cycle, and at the End of Treatment (EOT) visit (up to 1 year)