Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Conditions

• Advanced Metastatic Cancer
• Breast Cancer
• Cancer
• Ovarian Cancer
• Prostate
• Small Cell Lung Cancer
• Solid Tumor Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SYS6043 — DRUG
  Administered by intravenous injection

Study Details

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.

Key Dates

Start date

Mar 3, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2029

Completion

Apr 30, 2030

Study Design

Enrollment

386 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a). [ Time Frame: An average of 1 year. ]

Central Contacts

• Director, Clinical Operations
  609-356-0210
  [email protected]
• Regulatory Operations Manager
  609-356-0210
  [email protected]

Locations (5)

Find similar trials in Plantation, FL

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