NCT03526835 · Merus N.V.
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
What this study is about
This is a Phase 1/2 where both patients and doctors know the treatment given, multi-center, multi-national study with an initial gradually increasing doses part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The gradually increasing doses part has been completed and the RP2D will be further evaluated in an expansion part of the study.
View original scientific description
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.
Interventions
DRUG
MCLA-158
full-length IgG1 bispecific antibody targeting EGFR and LGR5
COMBINATION_PRODUCT
MCLA-158 + Pembrolizumab
MCLA-158 in combination with pembrolizumab will be explored first in HNSCC patients eligible to receive pembrolizumab as first-line monotherapy.
COMBINATION_PRODUCT
MCLA-158 + FOLFIRI
MCLA-158 in combination with FOLFIRI will be explored in mCRC patients with up to 1 line of prior regimen.
COMBINATION_PRODUCT
MCLA-158 + FOLFOX
MCLA-158 in combination with FOLFOX will be explored in mCRC patients with up to 1 line of prior regimen.
Primary outcome measures
Escalation: Number of patients with Dose Limiting Toxicities (DLTs) during Cycle 1
Time frame: 4 weeks
Evaluation of the number and severity of participants with treatment related toxicities observed during the dose escalation.
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer, and combination cohorts): Safety and tolerability: AEs and SAEs
Time frame: 6-12 months
Incidence, severity, and relationship of AEs and SAEs
Expansion (Single agent - randomized expansion in 2/3L Head and Neck cancer): Treatment discontinuations and dose modifications due to AEs
Time frame: 6-12 months
Treatment discontinuations due to AEs and dose modifications due to AEs
Expansion (single agent - randomized expansion in 2/3L Head and Neck cancer): Best overall response (BOR)
Time frame: 36 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining Best overall response (BOR)
Expansion (Single agent - non-randomized, and combination cohorts): Objective response rate (ORR)
Time frame: 36 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective response rate (ORR)
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
Time frame: 8 weeks
Incidence of TEAEs at Week 8
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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 com
Where
- La Jolla, California
- Los Angeles, California
- San Diego, California
- Lone Tree, Colorado
- Fort Myers, Florida
- Orlando, Florida
- Boston, Massachusetts
- St Louis, Missouri
- Ithaca, New York
- Syracuse, New York
- Cleveland, Ohio
- Maumee, Ohio
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2025 · Source of record for eligibility and locations