A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

NCT07110883 | Recruiting Phase 1

• 1 other identifier: SYS6023-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• The incidence of dose-limiting toxicity (DLT)

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

  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

  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.

  Up to approximately 2 years

Secondary Outcomes (10)

• Area Under the Serum Concentration Time Curve ( AUC)

  Up to approximately 4 years

• Maximum Plasma Concentration( Cmax)

  The serum concentrations were quantified using the IC-LC/MS assay.

• Minimum Plasma Concentration ( Cmin)

  Up to approximately 4 years

• Time to Maximum Plasma Concentration (Tmax)

  Up to approximately 4 years

• Anti-Drug Antibody（ADA）

  Up to approximately 4 years.

Study Arms (7)

Dose-escalation group

EXPERIMENTAL

Patients with advanced solid tumors receiving SYS6023 treatment at doses ranging from 0.5 mg/kg to 6.5 mg/kg.

Drug: SYS6023

Cohort-expansion A group

EXPERIMENTAL

Patients with Human Epidermal Growth Factor Receptor 3-positive(HER3+) / Hormone (estrogen and/or progesterone) receptor (HR)-positive (HR+)/ Human Epidermal Growth Factor Receptor 3-negative (HER2-) breast cancer receiving the recommended dose of SYS6023 treatment.

Drug: SYS6023

Cohort-expansion B group

EXPERIMENTAL

Patients with EGFR-positive non-small cell lung cancer receiving the recommended dose of SYS6023 treatment.

Drug: SYS6023

Cohort-expansion C group

EXPERIMENTAL

Patients with HER3+/HER2+ breast cancer receiving the recommended dose of SYS6023 treatment.

Drug: SYS6023

Cohort-expansion D group

EXPERIMENTAL

Patients with HER3+ platinum-resistant and recurrent ovarian cancer receiving the recommended dose of SYS6023 treatment.

Drug: SYS6023

Cohort-expansion E group

EXPERIMENTAL

Patients with locally advanced or metastatic non-small cell lung cancer positive for driver genes other than EGFR receiving the recommended dose of SYS6023 treatment.

Drug: SYS6023

Cohort-expansion F group

EXPERIMENTAL

Patients with other types of HER3+ advanced solid tumors receiving the recommended dose of SYS6023 treatment.

Drug: SYS6023

Interventions

SYS6023 DRUG

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

Cohort-expansion A group; Cohort-expansion B group; Cohort-expansion C group; Cohort-expansion D group; Cohort-expansion E group; Cohort-expansion F group; Dose-escalation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Depending on the trial phase, the following requirements must be met:
• \*\*Cohort Expansion Phase:\*\*
• \*\*Cohort A:\*\* HER3+ (by central lab), HR+/HER2- (HR+ defined as expressing estrogen receptor (ER), with or without progesterone receptor (PR) co-expression), locally advanced or metastatic breast cancer, previously treated with at least one line of systemic therapy including endocrine and CDK4/6 inhibitor treatment.
• \*\*Cohort B:\*\* EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer, previously treated with at least one line of systemic therapy, including EGFR Tyrosine Kinase Inhibitor (TKI) and platinum-based chemotherapy.
• \*\*Cohort C:\*\* HER3+ (by central lab), HER2+, locally advanced or metastatic breast cancer, previously treated with at least two lines of anti-HER2 systemic therapy including trastuzumab, taxane, and T-DM1 or TKI.
• \*\*Cohort D:\*\* HER3+ (by central lab), platinum-resistant recurrent ovarian cancer (defined as disease progression within \>3 months and ≤6 months after last platinum-based chemotherapy for first-line, or within 6 months for second-line or higher lines of platinum-based chemotherapy), and non-platinum refractory (defined as disease progression within 4 weeks after last platinum-based chemotherapy).
• \*\*Cohort E:\*\* Other driver gene-positive (e.g., ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, RET rearrangement, HER2 mutation, Met exon 14 skipping mutation, Met amplification, KRAS G12c mutation, etc.), locally advanced or metastatic non-small cell lung cancer, previously treated with corresponding targeted TKI therapy.
• \*\*Cohort F:\*\* other HER3+ (by central lab) tumor types (including but not limited to triple negative breast cancer (TNBC), driver gene mutation-negative NSCLC, prostate cancer, etc.) which may potentially benefit from this treatment, or known NRG1 fusion tumors, both of which have previously treated with at least one line of systemic therapy.
• At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST)1.1 criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival of at least 3 months;

You may not qualify if:

• 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;
• Any factors increasing the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relatives under 40 years old, concomitant use of drugs known to prolong QT interval;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Study Sites (2)

Affiliated Tumor Hospital of Harbin

Harbin, Heilongjiang, 150000, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• Shun Lu, M.D.

  Shanghai Chest Hospital

  STUDY CHAIR

• Qingyuan Zhang, M.D.

  Affiliated Tumor Hospital of Harbin

  STUDY CHAIR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants receive the same treatment, and there is no comparison group.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 8, 2025
• Study Start: August 15, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-07

Locations

CN (2)