Advanced/Metastatic Solid TumorsPhase 1/2NCT03526835
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing MCLA-158, MCLA-158 + Pembrolizumab and MCLA-158 + FOLFIRI in people with Advanced/Metastatic Solid Tumors and Colorectal Cancer, run by Merus B.V. at 54 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer
- What is being tested?
- MCLA-158, MCLA-158 + Pembrolizumab and MCLA-158 + FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 54 sitesin 7 countries
- Study dates
- 2 May 2018to Nov 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
- A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe/feasible).
- Amenable for biopsy (if safe/feasible).
- Measurable disease as defined by RECIST version 1.1 by radiologic methods.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks, as per investigator.
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- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
- Adequate organ function
- Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:
- SINGLE AGENT:
- SECOND-/THIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents and no previous exposure to EGFR inhibitors. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing therapy. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease. • Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.
- The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- 3L+ mCRC and 2L/3L HNSCC patients. (cohort open to enrolment) patients must have:
- No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, , as detected in plasma by ctDNA NGS central testing performed during screening.
- A microsatellite stable (MSS) tumor.
- Received ≥2 and no more than 4 lines of prior therapy in the metastatic setting including:
- Chemotherapy with oxaliplatin, irinotecan, and a fluoropyrimidine,
- Targeted therapy with an anti-VEGF therapy
- COMBINATION:
- FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries; patients should not have previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if ended ≥6 months prior to signing the ICF. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.
- mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS/ RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay, to be confirmed by the sponsor, and must have an MSS tumor. Patients must be naive to prior anti-EGFR therapy.
- Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab.
- Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab
Who cannot join
- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
- Known leptomeningeal involvement.
- Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
- Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or anticancer immunotherapies, a washout period of 6 weeks is required.
- Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)
- Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.
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- Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.
- History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.
- Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg and/or diastolic BP > 100 mmHg) with appropriate treatment or unstable angina. History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia). History of myocardial infarction within 6 months of study entry.
- History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3 years.
- Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.
- Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.
- Patients with known infectious diseases:
- Active hepatitis B infection (hepatitis B surface antigen [HBsAg] positive) without receiving antiviral treatment. ii. Positive test for hepatitis C ribonucleic acid (HCV) RNA).
- Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-158.
Trial locations and contacts
54 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 7 countries
United States31 sites, 25 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
Massachusetts General Hospital - Dana Farber
Boston, Massachusetts, 02114
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Ohio State University
Columbus, Ohio, 43221
- Recruiting
Texas Oncology
Dallas, Texas, 75246
- Completed
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Completed
Florida Cancer Specialists
Fort Myers, Florida, 33901
- Recruiting
University of Florida
Gainesville, Florida, 32610
- Recruiting
Georgetown University Medical Center
Georgetown, Washington, 20007
- Recruiting
Oncology Consultants
Houston, Texas, 77030
- Recruiting
Cayuga Medical Center
Ithaca, New York, 14850
Danielle Rao
- Recruiting
UCSD
La Jolla, California, 92093
- Recruiting
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
- Active, not recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
- Recruiting
The University Of Tennessee Health Science Center
Memphis, Tennessee, 38103
- Completed
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Mt. Sinai
New York, New York, 10029
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Completed
SSM OKC Hightower Clinical
Oklahoma City, Oklahoma, 73102
- Recruiting
Sarah Cannon Research Institute (Lake Nona)
Orlando, Florida, 32827
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24014
- Recruiting
Utah Cancer Specialists
Salt Lake City, Utah, 84106
- Recruiting
University of Utah Health Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
- Recruiting
Sharp Healthcare
San Diego, California, 92123
Danica Griffin
- Recruiting
Cancer Care Northwest
Spokane, Washington, 99202
- Completed
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110
- Recruiting
Washington University School of Medicine at St Louis
St Louis, Missouri, 63110
- Recruiting
Hematology-Oncology Associates of Central New York
Syracuse, New York, 13057
- Recruiting
Texas Oncology
Tyler, Texas, 75702
France8 sites, 7 recruiting
- Recruiting
Hopital Saint Andre, CHU Bordeaux
Bordeaux
Delphine Padenon
- Recruiting
Centre Leon Berard
Lyon
- Active, not recruiting
Hopital La Timone
Marseille
- Recruiting
Institut Régional du Cancer de Montpellier
Montpellier
Justine Rochet
- Recruiting
Centre Antoine Lacassagne
Nice
- Recruiting
Institut Curie
Paris
- Recruiting
Institut Gustave Roussy
Paris
- Recruiting
Centre Henri Becquerel
Rouen
Amelie Poullain
Spain5 sites, 5 recruiting
- Recruiting
Vall d'Hebron
Barcelona
- Recruiting
Hospital 12 de Octubre
Madrid
- Recruiting
Clinica Universidad de Navarra
Pamplona
Mercedes Egana
- Recruiting
Hospital Universitario de Navarra
Pamplona
- Recruiting
Instituto Valenciano de Oncologia
Valencia
Belgium4 sites, 3 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels
- Completed
Institut Jules Bordet
Brussels
- Recruiting
UZ Gent
Ghent
- Recruiting
Chu Ucl Namur Site De Sainte-Elisabeth
Namur
Netherlands3 sites, 3 recruiting
- Recruiting
NKI - Antoni van Leeuwenhoek
Amsterdam
- Recruiting
UMC Radboud
Nijmegen
- Recruiting
UMC Utrecht
Utrecht
United Kingdom2 sites, 1 recruiting
- Completed
Cambridge University Hospitals NHS Foundation Trust
Cambridge
- Recruiting
Sarah Cannon Research Institute
London
Italy1 site, 1 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
About this study
Official title: Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors
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.
Read the detailed description
Study Design:
This open label, multicenter, first-in-human study consists of 2 parts. Part 1 is a dose escalation to find the recommended Phase II dose (RP2D) of MCLA-158 studying patients with metastatic colorectal cancer (mCRC). Enrollment in the dose escalation part has been completed.
In the dose expansion (single-agent cohorts) part of the study, the activity, safety, and tolerability of MCLA-158 at 1500 mg every 2 weeks (Q2W) (preliminary RP2D) as a single agent will be evaluated in cohorts of selected solid tumor indications with dependency on EGFR signaling. The most recently enrolled cohorts were in patients with head and neck squamous cell carcinoma (HNSCC), gastric/ gastroesophageal junction adenocarcinoma (GEA) with EGFR amplification and/or high EGFR expression, esophageal carcinoma, and squamous cell carcinoma of the lung. In the dose expansion part of the study, safety was also characterized at two dose levels in (2L/3L) HNSCC. Enrollment is currently being explored in 2L/3L HNSCC and 3L/4L/5L mCRC (RAS/RAF wild type) patients. Additionally, in the dose expansion (combination cohorts) part of the study, the activity, safety, and tolerability of MCLA-158 at 1500 mg Q2W will be evaluated in combination with other therapies. Enrollment in the combination cohort of treatment of MCLA-158 with pembrolizumab for the treatment of patients with first line (1L) HNSCC is closed. Additionally, two combination cohorts of MCLA-158 with FOLFIRI or with FOLFOX chemotherapy (i.e., 5-fluorouracil [5-FU], leucovorin, and irinotecan (FOLFIRI) or oxaliplatin (FOLFOX)) will be explored in mCRC (RAS/RAF wild type) patients in the 1L/2L setting.
Other expansion cohorts may be considered for monotherapy or combination treatment in the future
- Conditions
- Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, NSCLC, HNSCC
- Being tested
- MCLA-158, MCLA-158 + Pembrolizumab, MCLA-158 + FOLFIRI, MCLA-158 + FOLFOX
- Keywords
- Bispecific antibody, First-in-human, MCLA-158, Antibodies, Bispecific, immunologic factors, Cytokines, EGFR, LGR5
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCLA-158Drug
Also called petosemtamab
full-length IgG1 bispecific antibody targeting EGFR and LGR5
MCLA-158 + PembrolizumabCombination product
Also called petosemtamab
MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy.
MCLA-158 + FOLFIRICombination product
Also called petosemtamab
MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen.
MCLA-158 + FOLFOXCombination product
Also called petosemtamab
MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen.
| Study group | Role | What they receive |
|---|---|---|
| MCLA-158 (Single-Agent) | Experimental | In Part 1, the dose escalation phase, patients with metastatic CRC will receive escalating doses of MCLA-158 (every 2 weeks) until MTD or RP2D is reached. Each Cycle is 28 days. Single agent treatment. In Part 2, the expansion phase, participants with metastatic CRC and certain other solid tumors will receive intravenous infusion (i.v.) of MCLA-158 at the recommended Phase II dose (RP2D) every 2 weeks, at Day 1 and Day 15. The duration of each treatment cycle is 28 days. In addition, in the expansion phase, one randomized cohort will evaluate 2 doses (1100 mg and 1500 mg) of MCLA-158 in head and neck squamous cell carcinoma patients. Also in the expansion phase, a subcutaneous formulation of MCLA-158 will be evaluated. Receives: Drug: MCLA-158 |
| MCLA-158 + Pembrolizumab | Experimental | MCLA-158 in combination with pembrolizumab will be explored first in head and neck squamous cell carcinoma patients eligible to receive pembrolizumab as first-line monotherapy. Receives: Combination Product: MCLA-158 + Pembrolizumab |
| MCLA-158 + FOLFIRI combination chemotherapy | Experimental | MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen. Receives: Combination Product: MCLA-158 + FOLFIRI |
| MCLA-158 + FOLFOX combination chemotherapy | Experimental | MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen. Receives: Combination Product: MCLA-158 + FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Escalation: Number of patients with Dose Limiting Toxicities (DLTs) during Cycle 1
Evaluation of the number and severity of participants with treatment related toxicities observed during the dose escalation.
Measured: 4 weeks
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer, and combination cohorts): Safety and tolerability: AEs and SAEs
Incidence, severity, and relationship of AEs and SAEs
Measured: 6-12 months
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): Treatment discontinuations and dose modifications due to AEs
Treatment discontinuations due to AEs and dose modifications due to AEs
Measured: 6-12 months
Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): Best overall response (BOR)
Evaluation of clinical benefit assessed by RECIST v1.1 determining Best overall response (BOR)
Measured: 36 months
Expansion (Single agent - non-randomized, and combination cohorts): Objective response rate (ORR)
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective response rate (ORR)
Measured: 36 months
Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg: TEAEs
Incidence of TEAEs at Week 8
Measured: 8 weeks
Expansion: (subcutaneous cohort): Bioavailability of subcutaneous vs intravenous administration
Bioavailability of subcutaneous vs intravenous administration
Measured: 6 weeks
Expansion: (subcutaneous cohort): Area under the concentration versus time curve from time zero to time t [AUC0-t]
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Measured: 6 weeks
Expansion: (subcutaneous cohort): Maximum plasma concentration [Cmax]
Maximum plasma concentration as measured from all individual plasma concentrations
Measured: 8 weeks
Expansion: (subcutaneous cohort): Minimum plasma drug concentration [Ctrough]
Minimum plasma concentration as measured from all individual plasma concentrations
Measured: 6 weeks
Secondary outcomes (25)
Escalation & Expansion: (subcutaneous cohort): Best Overall Response (BOR)
Evaluation of clinical benefit assessed by RECIST v1.1 determining Best overall response (BOR)
Measured: 36 months
Expansion: Duration of response (DOR)
Evaluation of clinical benefit assessed by RECIST v1.1 determining duration of response (DOR)
Measured: 36 months
Expansion: Progression Free Survival (PFS)
Evaluation of clinical benefit assessed by RECIST v1.1 determining progression free survival (PFS)
Measured: 36 months
Expansion (mCRC combination cohorts): Progression Free Survival (PFS) rate at 4 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining progression free survival (PFS) rate at 4 months
Measured: 4 months
Expansion (Single agent - non-randomized cohorts): Overall survival (OS)
Evaluation of clinical benefit determining overall survival (OS)
Measured: 36 months
Escalation & Expansion (single agent - non-randomized cohorts): Safety and tolerability: AEs and SAEs
Incidence, severity, and relationship of AEs and SAEs
Measured: up to 30 days post-last dose
Escalation & Expansion (Single agent - non-randomized and Combination cohorts): Treatment discontinuations and dose modifications due to AEs
Treatment discontinuations due to AEs and dose modifications due to AEs
Measured: up to 30 days post-last dose
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): exposure-efficacy relationship of petosemtamab administered at 1100 mg and 1500 mg: Target Lesions
Percentage change from baseline in sum of the diameters of target lesions at Week 8
Measured: 8 weeks
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg: Grade 3-4 TEAEs
Incidence of Grade 3-4 TEAEs at Week 8
Measured: 8 weeks
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg: IRR TEAEs
Incidence of IRR TEAEs at Week 8
Measured: 8 weeks
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg : non-IRR TEAEs
Incidence of non-IRR TEAEs at Week 8
Measured: 8 weeks
Escalation and Expansion: Safety and tolerability: laboratory values
Number of participants with abnormal laboratory tests results
Measured: 6-12 months
Escalation and Expansion: Safety and tolerability: (ECG)
Number of participants with abnormal ECG readings
Measured: 6-12 months
Escalation and Expansion: Safety and tolerability: vital signs
Number of participants with abnormal vital signs
Measured: 6-12 months
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): Objective response rate (ORR)
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective response rate (ORR)
Measured: 36 months
Escalation & Expansion: Incidence of anti-drug antibodies against MCLA-158
Number of participants with anti-drug antibodies against MCLA-158
Measured: 36 months
Escalation: Cytokine Panel Expression Profile
Evaluation of the cytokine expression profile
Measured: 36 months
Escalation & Expansion: End of infusion (EOI) plasma concentration [Ceoi]
End of infusion (EOI) plasma concentration [Ceoi] as measured from all individual plasma concentrations
Measured: 36 months
Escalation & Expansion: Maximum plasma concentration [Cmax]
Maximum plasma concentration as measured from all individual plasma concentrations
Measured: 36 months
Escalation & Expansion: Plasma concentration at 0 hours [C0h]
Plasma concentration at 0 hours [C0h] as measured from all individual plasma concentrations
Measured: 36 months
Escalation & Expansion: Area under the concentration versus time curve from time zero to time t [AUC0-t]
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Measured: 36 months
Escalation & Expansion: Area under the concentration versus time curve [AUC0-∞]
Area under the concentration versus time curve [AUC0-∞]
Measured: 36 months
Escalation & Expansion: Clearance of plasma [CL]
Clearance of plasma [CL]
Measured: 36 months
Escalation & Expansion: Volume of distribution at steady state [Vss]
Volume of distribution at steady state [Vss]
Measured: 36 months
Escalation & Expansion: Half-life [t1/2]
Half-life [t1/2]
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start2 May 2018
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merus B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silke Thiele, MD, Study director, Merus B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526835
- Sponsor's protocol ID
- MCLA-158-CL01
- Other IDs
- 2017-004745-24, 2024-513627-16-01, 2017
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2018
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No