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A 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

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.

  • SHR-1316 Injection

    Drug

    SHR-1316 Injection.

  • Paclitaxel for Injection (Albumin-Bound)

    Drug

    Paclitaxel for Injection (Albumin-Bound).

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: FH-006 GroupExperimental treatment 3 interventions

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.
2

Recommended Phase II dose (RP2D)

Time frame
From the first dose of study medication up to 28 days.
3

Incidence and severity of adverse events (AEs) / serious adverse events (SAEs)

Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame
From signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks.

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

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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