M8891 First in Human in Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors, Metastatic Renal Cell Carcinoma

In brief

The purpose of this study was to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic (PK), pharmacodynamic and clinical activity of M8891 as single agent in participants with advanced solid tumors in Part 1.

Key facts

Study ID

NCT03138538

Run by

EMD Serono Research & Development Institute, Inc.

People needed

27

Starts

2017-08-08

Expected to finish

2020-09-16

Last updated by the study team

2022-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be refractory to or intolerant of existing cancer therapy(ies) known to provide clinical benefit.
• Histologically confirmed advanced solid tumors with no clear curative treatment options available after at least 1 prior systemic anticancer therapy.
• Tumor accessible for biopsies and agreement to conduct pre-dose and post-dose fresh tumor biopsies.
• Male or female subjects at least 18 years of age
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at Screening
• Histologic or cytologic evidence/proven of metastatic renal cell carcinoma (mRCC) with clear cell component
• Part 2A: Participants should have progressed to 1 or more previous lines of systemic anticancer therapy, excluding treatment with cabozantinib
• Part 2B: Participants should have progressed to 1 or 2 previous lines of systemic anticancer therapy, excluding treatment with cabozantinib. Participants should have failed to only 1 previous TKI for metastatic disease. Adjuvant therapy with sunitinib will be considered as 1 line of therapy for metastatic disease in the case that disease progression occurs during or within 3 months of the completion of the treatment.
• Other protocol defined inclusion criteria could apply

You may not qualify if…

• ECOG PS >= 2
• Extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation within 5 years of study start.
• Severe bone marrow, renal or liver impairment.
• Tumor in contact with, invading or encasing major blood vessels or radiographic evidence of significant cavitary pulmonary lesions
• Uncontrolled hypertension defined as sustained Blood Pressure (BP) > 150 millimeters of mercury (mm Hg) systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment
• Participant is pregnant or breastfeeding
• Part 2A and 2B: Previous use of cabozantinib or a MetAP2 inhibitor, tumor in contact with invading or encasing major blood vessels or radiographic evidence of significant cavitary pulmonary lesions
• Other protocol defined exclusion criteria could apply

Where it is running

• Smilow Cancer Hospital - Yale — New Haven, Connecticut, United States
• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Sidney Kimmel Cancer Center - Johns Hopkins — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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