A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

March 1, 2024 updated by: Merus N.V.

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 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.

The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. Enrollment in the dose escalation part has been completed.

Dose expansion (single-agent cohorts) In an expansion 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. Eligible solid tumor indications may include locally advanced unresectable or metastatic HNSCC, gastric/gastroesophageal junction adenocarcinoma (GEA) with EGFR amplification and/or high EGFR expression, esophageal carcinoma and pancreatic adenocarcinoma. Additionally, safety will be characterized at two dose levels in this setting.

Dose expansion (in combination with pembrolizumab cohort)

MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy. Other expansion cohorts may be considered for combination treatment in the future.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Institut Jules Bordet
        • Principal Investigator:
          • Christiane Jungels, MD
        • Contact:
          • Christiane Jungels, MD
          • Phone Number: + 32 2 541 31 11
      • Brussels, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Jean-Pascal Machiels, MD, PhD
        • Contact:
          • Phone Number: +32 2 764 36 51
        • Principal Investigator:
          • Jean-Pascal Machiels, MD, PhD
      • Gent, Belgium
        • Recruiting
        • UZ Gent
        • Contact:
          • Michael Saerens, MD
          • Phone Number: +32 9 332 07 83
        • Principal Investigator:
          • Michael Saerens, MD
      • Namur, Belgium
        • Recruiting
        • CHU UCL Namur Site de Sainte-Elisabeth
        • Principal Investigator:
          • Stephanie Henry, MD
        • Contact:
          • Stephanie Henry, MD
          • Phone Number: +32 (0)81 72 04 56
  • France
      • Bordeaux, France
        • Recruiting
        • Hopital Saint Andre, CHU Bordeaux
        • Principal Investigator:
          • Amaury Daste, MD
        • Contact:
      • Lyon, France
      • Marseille, France
        • Recruiting
        • Hôpital La Timone
        • Principal Investigator:
          • Sebastien Salas, MD
        • Contact:
      • Montpellier, France
        • Recruiting
        • Institut Regional du Cancer de Montpellier
        • Principal Investigator:
          • Thibault Mazard, MD
        • Contact:
      • Nice, France
      • Paris, France
        • Recruiting
        • Institut Curie
        • Contact:
        • Principal Investigator:
          • Christophe LE TOURNEAU, MD
      • Paris, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
        • Principal Investigator:
          • Antoine Hollebecque, MD
      • Rouen, France
        • Recruiting
        • Centre Henri Becquerel
        • Principal Investigator:
          • Florian Clatot, MD
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • NKI - Antoni van Leeuwenhoek
        • Contact:
          • Jan Paul de Boer, MD
          • Phone Number: +31 20 512 49 19
        • Principal Investigator:
          • Jan Paul de Boer, MD
      • Nijmegen, Netherlands
        • Recruiting
        • UMC Radboud
        • Contact:
          • Carla van Herpen
          • Phone Number: +3124-3614038
        • Principal Investigator:
          • Carla van Herpen, MD
      • Utrecht, Netherlands
        • Recruiting
        • UMC Utrecht
        • Contact:
          • Lot Devriese, MD
          • Phone Number: +31 88 75 562 30
        • Principal Investigator:
          • Lot Devriese, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Irene Brana, MD
      • Madrid, Spain
        • Recruiting
        • Hospital 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Lara Iglesias, MD
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
        • Principal Investigator:
          • Jose jlpicazo@unav.es, MD
      • Pamplona, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Principal Investigator:
          • Virginia Arrazubi, MD
        • Contact:
          • Patricia Ochoa
          • Phone Number: +(34) 848 42 25 76
      • Valencia, Spain
        • Recruiting
        • Instituto Valenciano de Oncologia
        • Contact:
          • Hector Aguilar, MD
          • Phone Number: +34 96 111 4229
        • Principal Investigator:
          • Hector Aguilar
  • United Kingdom
      • Cambridge, United Kingdom
        • Completed
        • Cambridge University Hospitals NHS Foundation Trust
      • London, United Kingdom
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UCSD
        • Principal Investigator:
          • Shumei Kato, MD
        • Contact:
          • Petrea Monson
          • Phone Number: 858-246-5674
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Jacob Thomas, MD
        • Contact:
          • Sandy Tran
          • Phone Number: 323-865-3935
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Principal Investigator:
          • Robert M Jotte, MD
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Sufficient Bien
          • Phone Number: 941-907-4737
        • Principal Investigator:
          • Amir Harandi, MD
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Sarah Cannon Research Institute (Lake Nona)
        • Principal Investigator:
          • Cesar Perez Batista, MD
        • Contact:
          • Ingrid Acker
          • Phone Number: 689-216-8500
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • SSM Health Saint Louis University Hospital
        • Principal Investigator:
          • Maurice Willis, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Emrulla Yilmaz, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • SSM OKC Hightower Clinical
        • Contact:
          • Caitlin Merrick
          • Phone Number: 405-464-7300
        • Principal Investigator:
          • David Lam, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • The University of Tennessee Health Science Center
        • Contact:
        • Principal Investigator:
          • Neil Hayes, MD
      • Nashville, Tennessee, United States, 37203
        • Completed
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants
        • Contact:
          • Carlos Cortez
          • Phone Number: 713-600-0978
        • Principal Investigator:
          • Mahran Shoukier, MD
      • Tyler, Texas, United States, 75702
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • Utah Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Stephan DiSean Kendall, MD
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah Health Huntsman Cancer Hospital
        • Contact:
          • Devin Baxter
          • Phone Number: 801-587-4767
        • Principal Investigator:
          • Jeffery Russell, MD, PhD, MBA
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia
        • Contact:
        • Principal Investigator:
          • Mark D Kochenderfer, MD
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Cancer Care Northwest
        • Contact:
          • Krystal Swenson
          • Phone Number: 509-228-1682
        • Principal Investigator:
          • Jessica Hellyer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.

  • Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:

    • COMBINATION FIRST-LINE HNSCC: 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.

    • SINGLE AGENT SECOND-/THIRD-LINE HNSCC PATIENTS: patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy as monotherapy or in combination with other agents, and have progressed to a platinum-based chemotherapy less than 6 months from the last platinum dose, with no previous exposure to EGFR inhibitors. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease not amenable to standard therapy with curative intent.

      • 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.
    • GEA with histologically confirmed EGFR amplification (fluorescence in situ hybridization [FISH] score EGFR/CEP7 ratio ≥2.0, or next generation sequencing [NGS] EGFR copy ≥8, or cfDNA ≥2.5, or EGFR IHC H-score ≥200)
    • Esophageal carcinoma
    • Pancreatic adenocarcinoma
    • Patients with other indications must have been previously treated with at least 2 lines of the standard approved therapy (when applicable) in the locally advanced/unresectable or metastatic setting. Patients with malignant salivary gland tumors and squamous esophageal cancer may be enrolled after progression on 1 line of systemic standard treatment.
  • A baseline fresh tumor sample (FFPE) from a metastatic or primary site.
  • Amenable for biopsy.
  • 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.
  • Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
  • Adequate organ function

Exclusion Criteria:

  • 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 trial 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 longer 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.
  • 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 or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents.
  • Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 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 at least 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 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 the following infectious diseases:

    • Active hepatitis B infection (HBsAg positive) without receiving antiviral treatment. Note: Patients with active hepatitis B (HBsAg positive) must receive antiviral treatment with lamivudine, tenofovir, entecavir, or other antiviral agents, starting at least ≥7 days before the initiation of the study treatment. Patients with antecedents of hepatitis B (anti-HBc positive, HBsAg and HBV-DNA negative) are eligible.
    • Positive test for hepatitis C ribonucleic acid (HCV RNA). Note: Patients in whom HCV infection resolved spontaneously (positive HCV antibodies without detectable HCV-RNA) or who achieved a sustained response after antiviral treatment and show absence of detectable HCV RNA ≥6 months (with the use of IFN-free regimens) or ≥ 12 months (with t the use of IFN-based regimens) after cessation of antiviral treatment are eligible.
  • Patients with current cirrhotic status of Child-Pugh class B or C; known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Pregnant or lactating women; 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCLA-158

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 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 the expansion phase, 2 doses (1100 mg and 1500 mg) of MCLA-158 will be evaluated in a cohort of head and neck squamous cell carcinoma patients
Drug: MCLA-158
full-length IgG1 bispecific antibody targeting EGFR and LGR5
Other Names:
  • petosemtamab
Experimental: MCLA-158 + Pembrolizumab
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.
Combination product: MCLA-158 +Pembrolizumab
MCLA-158 in combination with pembrolizumab (non-IMP) will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy.
Other Names:
  • petosemtamab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Escalation: Number of patients with Dose Limiting Toxicities (DLTs)
Time Frame: 6-12 months
Evaluation of number of participants with treatment related toxicities observed during the dose escalation.
6-12 months
Escalation: Severity of Dose Limiting Toxicities (DLT)
Time Frame: 6-12 months
Evaluation of the severity of treatment related toxicities observed during the dose escalation.
6-12 months
Escalation and Expansion: Safety and tolerability: laboratory values
Time Frame: 6-12 months
Number of participants with abnormal laboratory tests results
6-12 months
Dose Expansion (Combination): Safety and tolerability: AEs and SAEs
Time Frame: 6-12 months
Incidence, severity, and relationship of AEs and SAEs, in combination with pembrolizumab in HNSCC
6-12 months
Escalation and Expansion: Safety and tolerability: (ECG)
Time Frame: 6-12 months
Number of participants with abnormal ECG readings
6-12 months
Escalation and Expansion: Safety and tolerability: vital signs
Time Frame: 6-12 months
Number of participants with abnormal vital signs
6-12 months
Escalation and Expansion: Safety and tolerability
Time Frame: 6-12 months
Treatment discontinuations due to AEs and dose modifications due to AEs
6-12 months
Expansion (single agent - non-randomized): Objective overall response rate (ORR)
Time Frame: 36 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR)
36 months
Escalation: RP2D
Time Frame: 36 months
To determine the preliminary RP2D of single agent petosemtamab in mCRC patients who have progressed on chemotherapy, with or without an anti-vascular endothelial growth factor (VEGF) therapy, and with an anti-EGFR therapy (if RASwt)
36 months
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer- Incidence and severity and relationship of AEs and SAEs
Time Frame: 12 months
To descriptively characterize all relevant clinical safety and efficacy data within the study
12 months
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer- Treatment discontinuations due to AEs and dose modifications due to AEs
Time Frame: 12 months
To descriptively characterize all relevant clinical safety and efficacy data within the study
12 months
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer- Best overall response
Time Frame: 12 months
To descriptively characterize all relevant clinical safety and efficacy data within the study
12 months
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer- Incidence of AEs and SAEs
Time Frame: 12 months
To characterize the exposure-safety relationship of petosemtamab administered at 1100 mg and 1500 mg Q2W in terms of TEAEs
12 months
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer- Incidence of TEAEs
Time Frame: 8 weeks
To characterize the incidence of TEAEs at Week 8
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expansion: Frequency of Treatment-Related Adverse Events (AE)
Time Frame: up to 30 days post-last dose
Evaluation of the number of participants with AEs or SAEs that are related to treatment as assessed by CTCAE version 4.03
up to 30 days post-last dose
Expansion: Frequency of dose interruptions and reductions
Time Frame: up to 30 days post-last dose
Evaluation of the number of dose interruptions and reductions
up to 30 days post-last dose
Escalation & Expansion: Incidence of anti-drug antibodies against MCLA-158
Time Frame: 36 months
Number of participants with anti-drug antibodies against MCLA-158
36 months
Escalation & Expansion: Serum titers of anti-drug antibodies
Time Frame: 36 months
Serum titers of anti-drug antibodies against MCLA-158
36 months
Escalation & Expansion: Biomarkers for EGFR activation and signaling
Time Frame: 36 months
Evaluation of biomarker results for EGFR activation and signaling
36 months
Escalation & Expansion: EGFR expression
Time Frame: 36 months
Biomarkers in tumor samples relevant to EGFR expression in relation to early tumor response profile of MCLA-158
36 months
Escalation & Expansion: LGR5 expression
Time Frame: 36 months
Biomarkers in tumor samples relevant to LGR5 expression in relation to early tumor response profile of MCLA-158
36 months
Escalation & Expansion: Duration of response (DOR)
Time Frame: 36 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining duration of response (DOR)
36 months
Escalation & Expansion: Progression Free Survival (PFS) and survival
Time Frame: 36 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective progression free survival (PFS) and/or survival
36 months
Escalation & Expansion: End of infusion (EOI) plasma concentration [Ceoi]
Time Frame: 36 months
End of infusion (EOI) plasma concentration [Ceoi] as measured from all individual plasma concentrations
36 months
Escalation & Expansion: Maximum plasma concentration [Cmax]
Time Frame: 36 months
Maximum plasma concentration as measured from all individual plasma concentrations
36 months
Escalation & Expansion: Plasma concentration at 0 hours [C0h]
Time Frame: 36 months
Plasma concentration at 0 hours [C0h] as measured from all individual plasma concentrations
36 months
Escalation & Expansion: Area under the concentration versus time curve from time zero to time t [AUC0-t]
Time Frame: 36 months
Area under the concentration versus time curve from time zero to time t [AUC0-t]
36 months
Escalation & Expansion: Area under the concentration versus time curve [AUC0-∞]
Time Frame: 36 months
Area under the concentration versus time curve [AUC0-∞]
36 months
Escalation & Expansion: Clearance of plasma [CL]
Time Frame: 36 months
Clearance of plasma [CL]
36 months
Escalation & Expansion: Volume of distribution at steady state [Vss]
Time Frame: 36 months
Volume of distribution at steady state [Vss]
36 months
Escalation & Expansion: Time to reach maximum concentration [tmax]
Time Frame: 36 months
Time to reach maximum concentration [tmax]
36 months
Escalation & Expansion: Half-life [t1/2]
Time Frame: 36 months
Half-life [t1/2]
36 months
Expansion: Severity of Treatment-Related Adverse Events (AE)
Time Frame: up to 30 days post-last dose
Evaluation of the severity of AEs that are related to treatment as assessed by CTCAE version 4.03
up to 30 days post-last dose
Escalation & Expansion: Overall survival (OS)
Time Frame: 36 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining overall survival (OS)
36 months
Escalation & Expansion (non-randomized cohort): Cytokine Panel Expression Profile
Time Frame: 36 months
Evaluation of the cytokine expression profile
36 months
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
Time Frame: 8 weeks
Percentage change from baseline in sum of the diameters of target lesions at Week 8
8 weeks
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer): exposure-efficacy relationship of petosemtamab administered at 1100 mg and 1500 mg: TEAEs
Time Frame: 8 weeks
Incidence of Grade 3-4 TEAEs at Week 8
8 weeks
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer): exposure-efficacy relationship of petosemtamab administered at 1100 mg and 1500 mg: IRR TEAEs
Time Frame: 8 weeks
Incidence of IRR TEAEs at Week 8
8 weeks
Expansion (single agent, randomized expansion in 2/3L Head and Neck cancer): exposure-efficacy relationship of petosemtamab administered at 1100 mg and 1500 mg : non-IRR TEAEs
Time Frame: 8 weeks
Incidence of non-IRR TEAEs at Week 8
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Escalation & Expansion: Biomarkers for Wnt signaling proteins
Time Frame: 36 months
Evaluation of biomarker results for Wnt signaling proteins
36 months
Escalation & Expansion: Biomarkers for genetic aberrations in ctDNA
Time Frame: 36 months
Evaluation of biomarker results in genetic aberrations in ctDNA
36 months
Escalation & Expansion: Biomarkers for differential expression of miRNA
Time Frame: 36 months
Evaluation of biomarker results for differential expression of miRNA
36 months
Escalation & Expansion: Biomarkers for differential expression of mRNA
Time Frame: 36 months
Evaluation of biomarker results for differential expression of mRNA
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merus N.V.

Collaborators

Chiltern International Inc.
Q2 Solutions
Oncology Therapeutic Development (OTD)
4Clinics

Investigators

  • Study Director: Eduardo Pennella, MD, Merus N.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCLA-158-CL01
  • 2017-004745-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are made available only to the individual patient upon specific request of that individual patient or its treating physician.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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