HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by Conjupro Biotherapeutics, Inc. · Updated on 2026-04-07
386
Participants Needed
5
Research Sites
17 weeks
Total Duration
Researchers are evaluating an investigational drug called SYS6043 in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. This open-label, multicenter Phase I study aims to assess the safety, tolerability, pharmacokinetics, and early anti-tumor effects of SYS6043, which targets the B7-H3 protein. The study also explores how the drug moves through the body and whether the immune system responds to it, with a focus on determining the dose that can be safely given to patients. The study has three parts dose escalation, pharmacokinetic expansion, and cohort expansion. Initially, doses are increased carefully to find the maximum tolerated dose or recommended Phase II dose. Next, selected doses are further studied for safety, drug behavior, and tumor response. The final part involves expanding participant groups to assess safety and effectiveness at the chosen dose. SYS6043 is given by intravenous infusion every three weeks, and dosing continues until the doctor decides to stop based on treatment response. Participants will provide consent, undergo screening tests, and attend all study visits. Researchers will monitor safety through adverse event tracking and follow participants until their disease progresses. Various assessments include tumor measurements, heart function tests, and immune response checks. Safety follow-up and long-term monitoring are included, with an average study duration of about one year for key outcomes such as adverse events, drug levels, tumor response, and protein expression related to treatment effects.
CONDITIONS
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
D
Director, Clinical Operations
R
Regulatory Operations Manager
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Conjupro Biotherapeutics, Inc.
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | SYS6043 (investigational ADC) | Current standard care |
|---|---|---|
| What it is | An investigational antibody‑drug conjugate targeting B7‑H3 (SYS6043), tested in a dose‑escalation and expansion design in patients with advanced or metastatic solid tumors. | Standard systemic therapies such as chemotherapy, targeted therapy, or immunotherapy, depending on tumor type and prior treatment history. |
| Role in the trial | Single investigational arm undergoing sequential dose escalation, PK expansion, and cohort expansion phases. | Not evaluated in this study; serves as external context. |
| Primary use | To determine safety, tolerability, pharmacokinetics, maximum tolerated dose and recommended Phase II dose, and preliminary antitumor activity of SYS6043. | To manage advanced or metastatic solid tumors using therapies backed by clinical guidelines and prior evidence. |
| How it is given or performed | SYS6043 is given by intravenous injection following a dose‑escalation and expansion design. | Administration depends on the specific therapy, such as IV chemotherapy or oral targeted agents. |
| Evidence status | Preliminary evidence from early‑phase trial suggesting manageable safety and antitumor activity in refractory solid tumors. | Established evidence from clinical guidelines and trials supports use of chemotherapy, targeted therapy, or immunotherapy based on tumor type. |
| Important risks | Risks under evaluation include treatment‑emergent adverse events and dose‑limiting toxicities as defined in the trial. | Safety risks vary by therapy and include known toxicities of systemic treatments such as myelosuppression, organ toxicity, or immune‑related effects. |
| Important limitations | Findings are based on a non‑randomized, early‑phase single‑arm study in heterogeneous tumor types; efficacy and safety must be confirmed in later‑phase trials. | Effectiveness depends on tumor type, prior therapies, and biomarker status; not all patients respond to standard treatments. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo dose escalation to determine the maximum tolerated dose and recommended Phase II dose of SYS6043.
Multiple visits during dose escalation
Duration - Up to 1 year
Participants receive SYS6043 at selected dose levels to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity.
Regular visits for treatment and assessments
Duration - Up to 1 year
Participants are monitored for ongoing safety and treatment effects after completing SYS6043 treatment.
Periodic visits for follow-up assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Have more questions? Get in touch with our team for quick support
Chinese Society Of Clinical Oncology Csco Diagnosis And Treatment Guidelines For Colorectal Cancer Working Group
https://pubmed.ncbi.nlm.nih.gov/30996570/Apar Kishor P Ganti, Billy W Loo, Michael Bassetti...
https://pubmed.ncbi.nlm.nih.gov/34902832/Conjupro Biotherapeutics, Inc.
Lead Sponsor
