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Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Salubris Biotherapeutics Inc
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 from first patient dosed to end of escalation, up to 14 months.
Awards & highlights
No Placebo-Only Group

Summary

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered JK06 in patients with unresectable locally, advanced or metastatic cancer.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first patient dosed to end of escalation, up to 14 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first patient dosed to end of escalation, up to 14 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-Finding
Dose-limiting Toxicity (DLT)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Disease Control Rate (DCR)
Immunogenicity of JK06 by blood level measurement
Objective Response Rate (ORR)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
The RP2D/OBD of JK06 determined by the Escalation arm. A cycle of treatment is defined as 21 days.
Group II: Dose EscalationExperimental Treatment1 Intervention
Escalating repeated doses of JK06 administered intravenously. A cycle of treatment is defined as 21 days.

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Who is running the clinical trial?

Salubris Biotherapeutics IncLead Sponsor
4 Previous Clinical Trials
559 Total Patients Enrolled
~103 spots leftby Apr 2028
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