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Part B for Skin Cancer

Phase 1
Waitlist Available
Led By Ding Wang, MD
Research Sponsored by Synermore Biologics Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 106
Awards & highlights

Study Summary

This trial is testing a new cancer drug, SYN125, to see if it is effective at treating solid tumors either alone or in combination with SYN004.

Eligible Conditions
  • Skin Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 106
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 106 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence of dose-limiting toxicities (DLTs)
Part B: Incidence of dose-limiting toxicities (DLTs)
Secondary outcome measures
Area under the serum concentration time-curve over the dosing interval
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Clearance
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment2 Interventions
Dose escalation of SYN125 administered with a fixed-dose of SYN004 (SYN004 will be administered immediately after SYN125 infusion is complete, if tolerated). Once cohorts with low and medium dose levels in Part A are completed and no DLTs are observed per cohort, Part B with the SYN125 low dose level + SYN004 will start and run in parallel with Part A. The high dose of SYN125 in a cohort in Part A will begin along with Part B.
Group II: Part AExperimental Treatment1 Intervention
Dose escalation of SYN125. Each dose level (low, medium, high) will be tested in a cohort of 3 patients. If no dose-limiting toxicity (DLT) is observed in the 3 patients, dose escalation will continue to the next SYN125 dose level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribaxamase
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Synermore Biologics USA LimitedUNKNOWN
1 Previous Clinical Trials
448 Total Patients Enrolled
Synermore Biologics Co., Ltd.Lead Sponsor
4 Previous Clinical Trials
716 Total Patients Enrolled
Ding Wang, MDPrincipal InvestigatorHenry Ford Hospital
1 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

SYN125 Clinical Trial Eligibility Overview. Trial Name: NCT04363242 — Phase 1
Skin Cancer Research Study Groups: Part B, Part A
Skin Cancer Clinical Trial 2023: SYN125 Highlights & Side Effects. Trial Name: NCT04363242 — Phase 1
SYN125 2023 Treatment Timeline for Medical Study. Trial Name: NCT04363242 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions
2020. "A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04363242.
~4 spots leftby Apr 2025
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