Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Gilead Sciences

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 dose date up to 12 weeks post treatment (up to approximately 2 years after the last dose or until disease progression)

Awards & highlights

No Placebo-Only Group

Summary

The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.

Eligible Conditions

Colon Cancer
Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose date up to 12 weeks post treatment (up to approximately 2 years after the last dose or until disease progression)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose date up to 12 weeks post treatment (up to approximately 2 years after the last dose or until disease progression)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose date up to 12 weeks post treatment (up to approximately 2 years after the last dose or until disease progression) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Duration of Response

Overall Survival

Progression-free Survival

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase1: Dose-escalation Phase: Labetuzumab Govitecan (LG) Once Weekly DosingExperimental Treatment1 Intervention

Participants will receive 8, 12 and 16 mg/dose of LG once weekly dosing until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles, with a contingency to examine intermediate dose levels of 10 or 14 mg/kg, or if necessary to a lower dose level of 6 mg/kg.

Group II: Phase1: Dose-escalation Phase: LG Twice Weekly DosingExperimental Treatment1 Intervention

Participants will receive 6 and 9 mg/kg per dose twice weekly dose of LG until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles. A lower dose level of 4 mg/kg may be added if \> 1 out of 3 or 2 out of 6 participants are unable to tolerate all 4 doses without dose delay or reduction.

Group III: Phase 2: Dose-expansion Phase: LG Once or Twice Weekly DosingExperimental Treatment1 Intervention

Participants will receive selected doses of LG once or twice weekly until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to 8 cycles.

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