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

ConditionMalignant Solid Tumor
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • FH-006

    Drug

    Intravenous injection once every two weeks (Q2W), with a treatment period of 28 days

  • FH-006

    Drug

    administered once every 3 weeks (Q3W), with a treatment period of 21 days

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Queue AExperimental treatment 1 intervention
Group B: Queue BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT: 21or28 days after the first administration of each subject

Time frame
21or28 days after the first administration of each subject
2

AE: from Day1 to 30 days after last dose

Time frame
from Day1 to 30 days after last dose
3

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
4

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

Secondary outcomes

1

Immunogenic indicators: anti-FH-006 antibody (ADA)

Time frame
through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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