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A Study of SYS6051 in Subjects With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand the clinical study and voluntarily sign the written ICF;

Age ≥ 18 years;

Have at least one measurable lesion according to RECIST 1.1;

ECOG performance status score of 0 to 1;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • SYS6051

    Drug

    SYS6051 is administered by intravenous infusion every 3 weeks (Q3W). The doses administered for the first and subsequent visits of SYS6051 will be calculated based on the weight at screening/baseline and prior to dosing at subsequent visits.

Treatment groups

114 Participants
are divided into 1 treatment group
Group A: SYS6051Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity (DLT)

Time frame
From Day 1 to Day 21
2

Frequency and severity of AE

Time frame
From Day 1 to 30 days after last dose.
3

Maximal tolerable dose (MTD)

Time frame
From Day 1 to 12 months.
4

Recommended phase 2 dose (RP2D)

Time frame
From Day 1 to 12 months.

Secondary outcomes

1

Cmax

Time frame
From Day 1 to 12 months.
2

AUCss,

Time frame
From Day 1 to 12 months.
3

ORR

Time frame
From Day 1 to 12 months.
4

PFS

Time frame
From Day 1 to 12 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

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