Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works. Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment. * Have safety follow-up (SFU), and long-term follow-up. * Be followed until progression.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Major:
• Aged ≥18 years old (on the date of signing the ICF).
• Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy.
• Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled.
• Expected life expectancy of ≥ 3 months.
• ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment.
• LVEF ≥ 50% as shown by ECHO or MUGA within 28 days prior to enrollment.
Locations
United States
Florida
BRCR Global
RECRUITING
Plantation
Florida Clinical Trials Group
RECRUITING
Plantation
Texas
NEXT Oncology Austin
RECRUITING
Austin
NEXT Oncology San Antonio
RECRUITING
San Antonio
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Contact Information
Primary
Director, Clinical Operations
clinicaltrials.gov@cspcus.com
609-356-0210
Backup
Regulatory Operations Manager
clinicaltrials.gov@cspcus.com
609-356-0210
Time Frame
Start Date:2026-03-03
Estimated Completion Date:2030-04
Participants
Target number of participants:386
Treatments
Experimental: Phase Ia dose escalation is the first part (Part 1) of this study.
The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D (Recommended phase II dose).
Experimental: Phase Ia PK expansion (Part 2).
Phase Ia PK expansion (Part 2) will be conducted at 2-3 dose levels deemed acceptable (≤MTD) in terms of safety/tolerability as assessed by the SMC, to further evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of SYS6043.
Experimental: Phase Ib cohort expansion (Part 3).
Phase Ib cohort expansion (Part 3) will further evaluate the safety and efficacy of SYS6043 at the selected RP2D dose (1-2 dose levels).~Based on the obtained clinical study data and the participants' benefit/risk assessments, the SMC may consider initiating some or all of the following cohorts and may terminate enrollment for certain cohorts early based on clinical study data after initiation:~Cohort 1: Extensive-stage small cell lung cancer (ES-SCLC) after treatment failure of systemic standard of care; Cohort 2: Advanced/unresectable or metastatic HR+ HER2- breast carcinoma Cohort 3: Advanced/unresectable or metastatic castration-resistant prostate cancer (mCRPC) after treatment failure of systemic standard of care. Participants with prostate cancer whose disease is limited to metastases to bone will comprise no more than 20% of the enrolled population; Cohort 4: Advanced/unresectable or metastatic ovarian carcinoma