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

Status
Active
Cancer Type
Lung Cancer
Pancreatic Cancer
Trial Phase
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 N.V.

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 (eNRGy)

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 adenocarcinoma 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 24 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.

Eligibility

  1. At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 15) in Group H;
  2. Performance status of ECOG 0 - 2;
  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 for at least 7 days prior to screening;
  10. Platelets =75 x 109/L without transfusion support for at least 7 days prior to screening;
  11. Hemoglobin =8 g/dL or =5 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 or no satisfactory alternative treatment options are available;
  18. Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other similarly-certified laboratories.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.