SYS6043 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, SYS6043, to determine its effectiveness for adults with advanced or hard-to-treat solid tumors. The main goals are to assess the drug's safety, identify potential side effects, and establish the optimal dose. Researchers also aim to evaluate whether SYS6043 can slow down or shrink tumors and if a specific protein in tumors influences the treatment's effectiveness. Individuals with solid tumors that have spread or cannot be treated with existing options, and who have at least one measurable tumor, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot take medications that prolong the QT interval (a heart rhythm measure). It's best to discuss your current medications with the study doctor.
Is there any evidence suggesting that SYS6043 is likely to be safe for humans?
Research has shown that SYS6043, a new drug under testing, has been studied for safety in patients with various advanced cancers. Early results suggest that SYS6043 is generally safe. In one study involving patients with advanced nasopharyngeal carcinoma, the drug demonstrated a manageable safety profile. Some side effects occurred, but they were mostly mild to moderate.
In another study with patients who had previously treated ovarian cancer, SYS6043 showed promising results in reducing tumor size. About 45.7% of patients experienced a noticeable decrease in their tumors. While side effects were monitored, they were typical for this kind of treatment.
SYS6043 remains in the early stages of testing, primarily to assess its safety and determine the correct dosage. Although some evidence suggests SYS6043 is safe, further research is necessary. Prospective trial participants should discuss potential side effects and personal risks with their doctor.12345Why do researchers think this study treatment might be promising?
Researchers are excited about SYS6043 because it offers a new approach to treating various advanced cancers, including small cell lung cancer, breast cancer, prostate cancer, and ovarian cancer. Unlike traditional chemotherapy, which targets rapidly dividing cells indiscriminately, SYS6043 is designed to target specific pathways involved in cancer cell survival and growth, potentially leading to more effective and less toxic treatments. This targeted action could mean fewer side effects and improved outcomes for patients who have not responded to standard treatments. The early phases of the trial are exploring optimal dosing to maximize these benefits, which could pave the way for a significant shift in cancer treatment strategies.
What evidence suggests that SYS6043 might be an effective treatment for cancer?
Research has shown that SYS6043, a new drug tested in this trial, holds potential for treating some advanced cancers. In previous studies with patients who had previously treated ovarian cancer, SYS6043 helped nearly half by shrinking their tumors or stopping their growth for a significant time. On average, this effect lasted about 8.3 months. SYS6043 targets a protein called B7-H3, often found in large amounts in some tumors. This protein helps cancer cells evade the immune system. By targeting B7-H3, SYS6043 may enable the immune system to attack the cancer more effectively. Early results suggest that SYS6043 could be a promising option for people with advanced cancers that are difficult to treat with standard therapies. This trial will further evaluate SYS6043 across different phases, including dose escalation and cohort expansion, to assess its safety and efficacy in various cancer types.12456
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced or metastatic solid tumors, including ovarian, prostate, lung, and breast cancers, whose cancer has come back or spread after standard treatments. Participants must be in good physical condition and have at least one tumor that can be measured.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
Trial Overview
The study tests SYS6043, an experimental drug given by IV every three weeks to see what dose is safe and how the body reacts. Researchers will also look for early signs of effectiveness against various advanced cancers.
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
Citations
1.
onclive.com
onclive.com/view/sys6043-shows-initial-antitumor-activity-in-pretreated-ovarian-endometrial-and-cervical-cancerSYS6043 Shows Initial Antitumor Activity in Pretreated ...
Among patients with pretreated ovarian cancer, SYS6043 achieved an objective response rate of 45.7% and median PFS of 8.3 months, including ...
Safety and efficacy of SYS6043, a novel B7-H3 targeting ...
Safety and efficacy of SYS6043, a novel B7-H3 targeting antibody-drug conjugates, in patients with advanced nasopharyngeal carcinoma.
SYS6043: Uses, Side Effects, Dosing & 3 Clinical Trials
SYS6043 is currently being investigated in clinical trials as a potential treatment for various types of cancer. These studies aim to determine ...
NCT07424547 | Phase I Study of SYS6043 in Patients With ...
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 ...
SYS6043 Safety, Tolerability, and Efficacy in Advanced/ ...
This study focuses on evaluating the safety, tolerability, and effectiveness of a new drug called SYS6043. This drug is an antibody-drug conjugate that targets ...
Safety and efficacy of SYS6043, a novel B7-H3 targeting ...
574 - Safety and efficacy of SYS6043, a novel B7-H3 targeting antibody-drug conjugates, in patients with advanced nasopharyngeal carcinoma.
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