Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma

Phase 1 & 2

Waitlist Available

Research Sponsored by NanoCarrier 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 through study completion, average 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see what the highest safe dose is, and how well it is tolerated.

Eligible Conditions

Soft Tissue Sarcoma
Sarcoma
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in quality of life as measured by EORTC QLQ-C30

Safety as measured by incidence and severity of TEAEs and laboratory anomalies

Other study objectives

AUC

Ceoi

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NC-6300Experimental Treatment1 Intervention

In Part 1, patients will receive an intravenous infusion of NC-6300 at escalating doses starting at a fixed dose on Day 1 of a 21-day cycle. After enrollment of the initial patient, the first patient in each cohort will not be enrolled until all patients at the immediately lower cohort have completed at least 1 full 21-day cycle. In Part 1, patients will continue to receive treatment until they experience disease progression, experience unacceptable toxicity, or withdraw voluntarily. Part 2 will begin after the RPII dose of NC-6300 is identified. All patients in Part 2 will receive NC-6300 at the RPII dose.

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