Actively Recruiting
Phase 1/2 Dose Escalation and Expansion Study of MCLA-158 Alone or with Other Treatments in Advanced Solid Tumors
Led by Merus B.V. ยท Updated on 2025-01-29
523
Participants Needed
45
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the bispecific antibody MCLA-158 in patients with advanced solid tumors, including metastatic colorectal cancer (mCRC) and head and neck squamous cell carcinoma (HNSCC). This Phase 1/2 open-label study aims to determine the recommended dose for further testing and assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor activity of MCLA-158 alone or combined with other treatments. The study includes patients with tumors showing dependence on EGFR signaling. The study has two parts: a completed dose escalation phase to find the recommended Phase II dose (RP2D) of MCLA-158, and a dose expansion phase to evaluate safety and activity at the RP2D of 1500 mg every two weeks. Patients receive MCLA-158 by intravenous infusion every 14 days in 28-day cycles. The expansion phase includes single-agent cohorts for various tumor types and combination cohorts where MCLA-158 is tested with pembrolizumab or chemotherapy regimens FOLFIRI or FOLFOX in specific colorectal cancer settings. Participants undergo regular assessments including monitoring for side effects, response to treatment, and laboratory tests such as blood work and heart function scans. Researchers measure outcomes like dose-limiting toxicities, overall response rates, treatment modifications due to adverse events, and survival over periods ranging from weeks up to 36 months. The study also evaluates drug levels in the body and immune responses during treatment. Total participation duration varies with each patient's treatment course and follow-up.
CONDITIONS
Brief 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 solid tumors with metastatic or locally advanced disease not suitable for curative treatment
- Availability of a baseline fresh tumor sample and amenability for biopsy if safe
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Left ventricular ejection fraction of 50% or higher
- Adequate organ function
- For expansion cohorts: specific tumor types and treatment histories as detailed (e.g., second/third-line HNSCC, certain mCRC patients without specific mutations and microsatellite stable tumors)
- No prior exposure to EGFR inhibitors for certain cohorts
- Patients must be 18 years or older
You will not qualify if you...
- Untreated or symptomatic central nervous system metastases or leptomeningeal involvement
- Participation in another clinical trial or investigational drug use within 4 weeks
- Recent systemic anticancer therapy within 4 weeks or 6 weeks for certain agents
- Need for immunosuppressive medication
- Major surgery or radiotherapy within 3 weeks before study treatment
- Persistent significant toxicities from prior treatments
- History of allergic reactions to study drug components
- Uncontrolled high blood pressure or serious heart conditions
- Recent myocardial infarction within 6 months
- Other active malignancies unless low risk and disease-free for 3 years
- Current serious illnesses including uncontrolled infections or pulmonary, metabolic, or psychiatric disorders
- Active hepatitis B or C infection without treatment
- Pregnancy or breastfeeding; must use effective contraception during and 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies; repeated 28-day cycles until disease progression or discontinuation
Participants receive intravenous infusions of MCLA-158 alone or in combination with other therapies every 2 weeks in cycles of 28 days. Treatment continues until disease progression or unacceptable toxicity.
Visits every 2 weeks for infusions
Duration - Up to 36 months
After treatment ends, participants are monitored for safety, treatment response, and long-term outcomes.
Periodic visits over up to 36 months
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 Rรฉgional 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
E
Ernesto Wasserman, MD
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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