SYS6043 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Phase Ia dose escalation to evaluate the MTD/maximum administered dose (MAD) and the RP2D using BOIN design
PK Expansion
Phase Ia PK expansion to further evaluate safety, tolerability, PK characteristics, and preliminary anti-tumor activity at 2-3 dose levels
Cohort Expansion
Phase Ib cohort expansion to evaluate safety and efficacy at the selected RP2D dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SYS6043
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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
The dose escalation is carried out using BOIN design, to evaluate the MTD/maximum administered dose (MAD) and the RP2D (Recommended phase II dose).
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Conjupro Biotherapeutics, Inc.
Lead Sponsor
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