Study of MT-5111 in HER2-positive Solid Tumors (MT-5111 Trial)

Phase 1

Waitlist Available

Research Sponsored by Molecular Templates, 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 day 1, day 8, and day 15 in each 21-day cycle

Awards & highlights

No Placebo-Only Group

Summary

This trial tests MT-5111, a lab-made protein, in people with certain types of cancer. It aims to find the best amount and check its safety. MT-5111 helps the immune system target and kill cancer cells by attaching to the HER2 protein.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 8, and day 15 in each 21-day cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 8, and day 15 in each 21-day cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 8, and day 15 in each 21-day cycle for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate safety and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

To evaluate tolerability and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

Secondary study objectives

PK as measured by concentrations of free MT-5111 (Area Under the Curve [AUC])

PK as measured by concentrations of free MT-5111 (Maximum Plasma Concentration [Cmax])

PK as measured by concentrations of free MT-5111 (Time to reach maximum concentration after drug administration [Tmax])

+2 more

Other study objectives

If warranted by the study results, to evaluate the exposure-response relationship for MT-5111

To correlate the pharmacodynamic markers of cancer under study (for breast cancer subjects using historic data, if available)

To correlate the pharmacodynamic markers of cancer under study relationship for MT-5111 using the PK, pharmacodynamics, safety, and tumor response variables.

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: Part B- Dose ExpansionExperimental Treatment1 Intervention

Part B - Dose Expansion in previously treated HER2-positive breast, GEA and other HER2-positive solid cancers Part B will include 3 expansion groups: Group B1 (Breast Cancer) will begin enrolling while Part A is being conducted following the completion of Cohort 7 and Subsequent cohort of subjects in group B1 may enroll into higher doses that are tolerated in Part A. Group B2 (GEA) and Group B3 (Other HER-2 positive solid cancer groups) will begin enrollment after the MTD or RP2D is determined in Part A. The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).

Group II: Part A- Dose EscalationExperimental Treatment1 Intervention

Part A- Dose Escalation in patients with previously treated advanced HER2-positive solid tumors. The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).

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