A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumor

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Histologically and/or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumor;

Sufficient archived or fresh tumor tissue samples must be provided for HER3 testing, among others;

Medical documentation must be provided before the first dose to clarify the following molecular typing information: HER2, HR receptor (including estrogen receptor (ER) and progesterone receptor (PR) ) expression for breast cancer participants, and Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) fusion, ROS Proto-Oncogene 1, receptor tyrosine kinase (ROS1) fusion, B-Raf Proto-Oncogene, serine/threonine kinase (BRAF) V600 mutation, Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, Neurotrophic Tyrosine Receptor Kinase (RET) rearrangement, HER2 mutation, MET Proto-Oncogene（Met）exon14 skipping mutation, Met amplification, KRAS Proto-Oncogene, GTPase G12C（KRAS G12c） mutation status for non-small cell lung cancer (NSCLC) participants;

Disqualifiers

Severe cardiac arrhythmia or conduction abnormality requiring clinical intervention, such as ventricular arrhythmia, grade II-III atrioventricular block, etc.;

Average QT interval corrected by Fridericia's formula (QTcF) > 450 ms on three resting 12-lead Electrocardiogram;

Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months before the first dose;

New York Heart Association (NYHA) classification ≥ Class II;

Trial design

Design model

Single group

Treatments tested in this trial

SYS6023
Drug
SYS6023 is a novel antibody-drug conjugate (ADC) targeting HER3, administered via intravenous infusion.

Treatment groups

400 Participants

are divided into 7 treatment groups

Treatment groups

See each treatment group below.

Group A: Dose-escalation groupExperimental treatment 1 intervention

Group B: Cohort-expansion A groupExperimental treatment 1 intervention

Group C: Cohort-expansion B groupExperimental treatment 1 intervention

Group D: Cohort-expansion C groupExperimental treatment 1 intervention

Group E: Cohort-expansion D groupExperimental treatment 1 intervention

Group F: Cohort-expansion E groupExperimental treatment 1 intervention

Group G: Cohort-expansion F groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The incidence of dose-limiting toxicity (DLT)

DLTs are quantified using Common Terminology Criteria for Adverse Events（CTCAE）5.0

Time frame

At the end of Cyecle 1 (each cycle is 21 days).

Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) (according to NCI-CTCAE 5.0)

AEs and SAEs are quantified using Common Terminology Criteria for Adverse Events（CTCAE） 5.0

Time frame

Baseline up to 28 days post last dose,. Up to approximately 2 years.

Recommended Phase 2 Dose（RP2D）

The "Recommended Phase 2 Dose" (RP2D) refers to the optimal dosage of the drug identified during Phase 1 clinical trials, which is then suggested for use in Phase 2 trials. This dosage is chosen based on a balance of factors including safety, tolerability, pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted in the body), and preliminary efficacy data.

Time frame

Up to approximately 2 years