M8891 First in Human in Solid Tumors

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is 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 and to determine the safety, tolerability, PK and antitumor activity of M8891 combined with cabozantinib in participants with metastatic renal cell carcinoma (mRCC) in Part 2 (Part 2a and Part 2b) of the study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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