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

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

About this trial

This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the preliminary efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with ability to understand and voluntarily agree to participate by giving written informed consent for the study.

Patients with unresectable recurrent or metastatic solid tumors.

There is at least one lesion that could be measured.

An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

Disqualifiers

Patients with known active central nervous system (CNS) metastases.

Subjects who had other malignancy in five years before the first dose.

Patients with tumor-related pain that can not be controlled as determined.

Patients with serious cardiovascular and cerebrovascular diseases.

Trial design

Design model

Single group

Treatments tested in this trial

  • FH-006 for Injection

    Drug

    FH-006 for injection.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: FH-006 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR is the efficacy endpoint of FH-006 for injection monotherapy in treatment of patients with advanced solid tumors.

Time frame
Assessed up to 6 months.

Secondary outcomes

1

Time to maximum concentration (Tmax)

Time frame
Up to 2 years.
2

Maximum concentration (Cmax)

Time frame
Up to 2 years.
3

Terminal half-life (t1/2)

Time frame
Up to 2 years.
4

Area Under the Concentration Versus Time Curve From Time Zero to T (AUC0-t)

Time frame
Up to 2 years.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: