Menu
Recruiting NCT06735144

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

Phase I / Phase II Interventional Malignant Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FH-006, FH-006.
Who it may be relevant to
Registry conditions: Malignant Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open Label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of FH-006 for Injection in Patients With Malignant Solid Tumors

Overview

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.

Interventions

  • Drug FH-006
    Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days
  • Drug FH-006
    administered once every 3 weeks (Q3W), with a treatment period of 21 days

Primary outcome measures

  • DLT: 21or28 days after the first administration of each subject [Time frame: 21or28 days after the first administration of each subject]
  • AE: from Day1 to 30 days after last dose [Time frame: from Day1 to 30 days after last dose]
  • Incidence and severity of serious adverse events (SAE): from Day1 to 30 days after last dose [Time frame: from Day1 to 30 days after last dose]
  • MTD or MAD： 21 or 28 days after the first dose of medication for each subject on dose escalation stage [Time frame: 21 or 28 days after the first dose of medication for each subject on dose escalation stage]
  • RP2D：Obtain two treatment evaluation data for the last subject during the dose expansion phase [Time frame: Obtain two treatment evaluation data for the last subject during the dose expansion phase]
Secondary outcome measures (1)
  • Immunogenic indicators: anti-FH-006 antibody (ADA) [Time frame: through study completion, an average of 2 years]

Eligibility criteria

Inclusion criteria

  • 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
  • At least one target lesion according to RECIST v1.1 criteria
  • Has a good level of organ function
  • Patients voluntarily joined the study and signed informed consent

Exclusion criteria

  • 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
  • Has severe infection within 4 weeks before the first medication
  • Any active autoimmune disease or a history of autoimmune disease
  • A history of immune deficiency
  • Has serious cardiovascular and cerebrovascular diseases
  • Clinically significant history of lung disease
  • The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
  • Having undergone surgery on important organs within 4 weeks prior to the first use of medication
  • Used attenuated live vaccine within 28 days prior to the first use of the investigational drug
  • Presence of other serious physical or mental diseases or laboratory abnormalities

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT06735144 · FH-006-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗