Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.

Eligibility criteria

Qualifiers

Women aged 18 to 75 (inclusive)

Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment.

ECOG score is 0 or 1

An expected survival of ≥3 months

Disqualifiers

Have other malignancies within the past 5 years

Active central nervous system metastasis without surgery or radiotherapy

Presence with uncontrollable third space effusion

Have undergone other anti-tumor treatment within 4 weeks before the first dose

Trial design

Treatments tested in this trial

  • FH-006
  • FH-006

Treatment groups

200 Participants
are divided into 2 treatment groups