A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors

NCT07744763 | Recruiting Phase 1

• 1 other identifier: SYS6041-001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  Incidence of DLT (Applicable only to the Phase I dose-escalation stage)

  21 days

• ORR

  ORR assessed by investigators per RECIST 1.1

  Through study completion，up to 2 years.

Secondary Outcomes (6)

• Number of participants with Adverse events (AEs)

  Up to 2 years

• DCR

  Up to 2 years

• Progression-free survival（PFS）

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• PK parameters

  Up to 2 years

Study Arms (1)

SYS6041

EXPERIMENTAL

intravenous injection

Drug: SYS6041

Interventions

SYS6041 DRUG

Farletuzumab-exatecan antibody-drug conjugate targeting human FRα

SYS6041

Eligibility Criteria

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

You may qualify if:

• Aged \>= 18 years.
• The expected survival time is \>=3 months.
• Eastern Cooperative Oncology Group (ECOG) 0\~1.
• Willing to provide recent tumor tissue specimens for FRα testing.
• At least one measurable lesion as defined by RECIST Version 1.1.
• The organ function level and related laboratory indicators must meet requirement.
• Agree to use reliable and effective methods of contraception during the study treatment period and for at least 5 months (for male subjects) or 8 months (for female subjects) after the last study treatment.

You may not qualify if:

• Known severe allergic reaction to the study drug or any other components/excipients in the formulation.
• Untreated (including those identified at baseline screening) or unstable parenchymal brain metastases, spinal metastases or spinal cord compression, carcinomatous meningitis.
• History of other malignant tumors within 3 years, or concurrent active malignant tumors.
• Prior treatment with ADCs carrying topoisomerase I inhibitor payloads.
• Adverse reactions from prior anti-tumor therapies have not recovered to Grade ≤1 per CTCAE v5.0.
• Received immunotherapy, macromolecular targeted therapy or other anti-tumor biotherapy within 4 weeks prior to the first dose; or received endocrine therapy, cytotoxic chemotherapy, small-molecule targeted therapy within 2 weeks prior to the first dose; or received traditional Chinese medicinal preparations with anti-tumor indications within 2 weeks prior to the first dose.
• Patients who have undergone major organ surgery within 28 days prior to the first dose, or have planned systemic or local tumor resection during the study period.
• Patients who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers systemically within 14 days prior to the first dose, or require continuous systemic administration of such agents during study treatment.
• Severe chronic or active infections requiring intravenous antibacterial, antifungal or antiviral therapy within 14 days prior to the first dose (including tuberculous infection, etc.).
• Subjects receiving long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy.
• Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 7 days prior to the first dose.
• Presence of risk factors for intestinal obstruction or intestinal perforation.
• Grade ≥2 severe diarrhea per CTCAE within 7 days prior to the first dose.
• History of non-infectious lung disease/pneumonitis requiring steroid therapy, or current interstitial lung disease/pneumonitis, or suspected such diseases identified by imaging examinations during screening.
• History of severe cardiovascular diseases.

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Study Sites (1)

Xiaohua

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

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

Model Details: This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors. The trial consists of four stages: Phase I dose-escalation stage, as well as Phase IIa dose-reassignment stage, dose-expansion stage and cohort-expansion stage.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: March 28, 2025
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

CN (1)