Actively Recruiting
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Led by Merus B.V. · Updated on 2025-01-29
523
Participants Needed
45
Research Sites
495 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.
CONDITIONS
Official Title
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic solid tumors not suitable for curative standard therapy
- Availability of a baseline fresh tumor sample (if safe and feasible)
- Amenable for biopsy if safe and feasible
- Measurable disease by RECIST version 1.1 radiologic methods
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiogram or MUGA scan
- Adequate organ function
- Expansion cohorts include patients with locally advanced unresectable or metastatic disease in selected indications
- For single agent cohorts: second-/third-line head and neck squamous cell carcinoma patients who progressed on or are intolerant to anti-PD-(L)1 and platinum therapies, no prior EGFR inhibitors, and no more than two prior treatments for recurrent or metastatic disease
- HPV status reported when available for oropharyngeal tumors
- Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx
- For 3L+ metastatic colorectal cancer: no oncogenic mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, no HER2 amplification, microsatellite stable tumor
- For combination cohorts: first-line head and neck squamous cell carcinoma patients eligible for pembrolizumab monotherapy with PD-L1 CPS ≥1, no prior systemic therapy in recurrent/metastatic setting except multimodal therapy ended 6 months prior
- Metastatic colorectal cancer patients must be RAS/RAF wild type, microsatellite stable, and naive to prior anti-EGFR therapy
- Chemotherapy regimens allowed prior to combination cohorts as specified
You will not qualify if you...
- Untreated, symptomatic, or uncontrolled central nervous system metastases or leptomeningeal involvement
- Participation in another clinical study or investigational drug treatment within 4 weeks prior to study entry
- Recent systemic anticancer therapy within 4 weeks or 5 half-lives before first dose; longer washout for certain agents
- Requirement for immunosuppressive medications
- Major surgery or radiotherapy within 3 weeks of first dose; prior radiotherapy to 25% or more of bone marrow
- Persistent clinically significant toxicities from prior therapies (except alopecia); stable sensory neuropathy grade ≤2 allowed
- Hypersensitivity to study drug components or human proteins
- Uncontrolled hypertension or unstable angina
- History of congestive heart failure (NYHA class II-IV) or serious arrhythmias needing treatment
- Myocardial infarction within 6 months of study entry
- Prior malignancies except certain low-risk cancers treated with no recurrence for 3 years
- Current dyspnea at rest or diseases requiring continuous oxygen therapy
- History or evidence of interstitial lung disease
- Serious uncontrolled illnesses including infections or psychiatric disorders
- Active untreated hepatitis B or positive hepatitis C RNA
- Pregnant or breastfeeding; must use effective contraception during and 6 months after study participation
AI-Screening
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Trial Site Locations
Total: 45 locations
1
UCSD
La Jolla, California, United States, 92093
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Sharp Healthcare
San Diego, California, United States, 92123
Actively Recruiting
4
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
Actively Recruiting
5
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Actively Recruiting
6
Sarah Cannon Research Institute (Lake Nona)
Orlando, Florida, United States, 32827
Actively Recruiting
7
Massachusetts General Hospital - Dana Farber
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Washington University School of Medicine at St Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Cayuga Medical Center
Ithaca, New York, United States, 14850
Actively Recruiting
11
Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
14
SSM OKC Hightower Clinical
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
15
The University Of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103
Actively Recruiting
16
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Completed
17
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
18
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
19
Texas Oncology
Tyler, Texas, United States, 75702
Actively Recruiting
20
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Actively Recruiting
21
University of Utah Health Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Actively Recruiting
22
Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, United States, 24014
Actively Recruiting
23
Cancer Care Northwest
Spokane, Washington, United States, 99202
Actively Recruiting
24
Cliniques universitaires Saint-Luc
Brussels, Belgium
Actively Recruiting
25
Institut Jules Bordet
Brussels, Belgium
Actively Recruiting
26
UZ Gent
Ghent, Belgium
Actively Recruiting
27
Chu Ucl Namur Site De Sainte-Elisabeth
Namur, Belgium
Actively Recruiting
28
Hopital Saint Andre, CHU Bordeaux
Bordeaux, France
Actively Recruiting
29
Centre Leon Berard
Lyon, France
Actively Recruiting
30
Hopital La Timone
Marseille, France
Actively Recruiting
31
Institut Régional du Cancer de Montpellier
Montpellier, France
Actively Recruiting
32
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
33
Institut Curie
Paris, France
Actively Recruiting
34
Institut Gustave Roussy
Paris, France
Actively Recruiting
35
Centre Henri Becquerel
Rouen, France
Actively Recruiting
36
NKI - Antoni van Leeuwenhoek
Amsterdam, Netherlands
Actively Recruiting
37
UMC Radboud
Nijmegen, Netherlands
Actively Recruiting
38
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
39
Vall d'Hebron
Barcelona, Spain
Actively Recruiting
40
Hospital 12 de Octubre
Madrid, Spain
Actively Recruiting
41
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
42
Hospital Universitario de Navarra
Pamplona, Spain
Actively Recruiting
43
Instituto Valenciano de Oncologia
Valencia, Spain
Actively Recruiting
44
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Completed
45
Sarah Cannon Research Institute
London, United Kingdom
Actively Recruiting
Research Team
G
Gianluca Laus, MD
CONTACT
E
Ernesto Wasserman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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