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A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion

Status
Active
Cancer Type
Lung Cancer
Pancreatic Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02912949
Protocol IDs
MCLA-128-CL01 (primary)
NCI-2019-06025
2014-003277-42
Study Sponsor
Merus NV

Summary

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent
study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of
zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion.

Objectives

Study Design :

This open label (all participants know the identity of the study drug), multicenter (more
than one study site), first-in-human study consisting of 2 parts. Part 1 is a dose escalation
and Part 2 is a dose expansion cohort. Part 1 has been completed.

Part 2 new patient populations examined:

- Group F: Patients with NSCLC with documented NRG1 fusion

- Group G: Patients with pancreatic cancer with documented NRG1 fusion

- Group H: Patients with any other solid tumor with documented NRG1 fusion

For these new patient populations, Part 2 will further characterize the safety and
tolerability of the selected dose level of zenocutuzumab (MCLA-128), as well as assessment of
CBR, defined as the proportion of patients with a CR, PR or durable SD (SD for at least 12
weeks in duration). For the new patient populations, overall response rate (ORR) and duration
of response (DOR) will be described.

The study consists of 3 periods: Screening period (up to 28 days prior to the first dose of
study drug); Treatment period (treatment cycles of 28 days); and Follow Up period (through 30
days after the last dose and quarterly checks for survival data for up to 2 years).
Participants' safety will be monitored throughout the study.

Number of Sites:

Up to 40 sites are estimated to be involved during Parts 1 and 2 of the study. Additional
sites may be added to ensure there is an acceptable enrollment rate or to replace
non-enrolling/withdrawn sites.

Eligibility

  1. At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 10) in Group H;
  2. Performance status of ECOG 0 or 1;
  3. Estimated life expectancy of at least 12 weeks;
  4. Toxicities incurred as a result of previous anti-cancer therapy resolved to =Grade 1;
  5. Treatment with anti-cancer medication or investigational drugs within the following intervals before the first dose of MCLA-128:
  6. >14 days or >5 half-lives prior to study entry, whichever is shorter.
  7. >14 days for radiotherapy.
  8. Recovery from major surgery or other complication to = Grade 2 or baseline ;
  9. Absolute neutrophil count =1.5 x 109/L without colony stimulating factor support;
  10. Platelets =100 x 109/L;
  11. Hemoglobin =8 g/dL or =2.2 mmol/L;
  12. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =3 x upper limit of normal (ULN) and total bilirubin =1.5 x ULN; in cases of metastatic liver involvement, ALT/AST =5 x ULN and total bilirubin =2 x ULN will be allowed; in cases of antecedents of Gilbert's syndrome when total bilirubin =3.0 x ULN or direct bilirubin =1.5 x ULN will be allowed;
  13. Estimated glomerular filtration rate (GFR) of >30 mL/min
  14. Able to provide a tumor biopsy sample (fresh strongly preferred or else archival);
  15. Not pregnant or nursing
  16. Fertile patients must use effective contraception during and for 6 month after completion of study therapy;
  17. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy;
  18. Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as PCR, next generation sequencing-based assays [DNA or RNA], or FISH as routinely performed at CLIA or other similarly-certified laboratories.
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