zenocutuzumab (MCLA-128) for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
1
Safety
START Hospital Universitario Madrid Sanchinarro, Madrid, Spain
Cancer of Pancreas+4 More
zenocutuzumab (MCLA-128) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether a drug may help treat cancer.

See full description

Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Solid Tumours Harboring NRG1 Fusion
  • NRG1 Fusion
  • Pancreatic Cancer Harboring NRG1 Fusion
  • NSCLC Harboring NRG1 Fusion

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether zenocutuzumab (MCLA-128) will improve 4 primary outcomes and 13 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of 36 months.

36 months
Anti-tumor response of zenocutuzumab (MCLA-128) by RECIST v1.1
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Clinical Benefit Rate (CBR) of zenocutuzumab (MCLA-128)
Correlation of anti-tumor activity and biomarkers
Duration of response (DOR)
Incidence of AE [safety and tolerability]
Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
Maximum plasma concentration [Cmax]
Objective overall response rate (ORR)
Progression Free Survival (PFS) and survival
Volume of distribution [V]
Volume of distribution at steady state [Vss]
area under the concentration versus time curve [AUC0-∞]
half-life [t1/2]
serum titers of anti-drug antibodies
time to reach maximum concentration [tmax]
6-12 months
Characterize the safety and tolerability of zenocutuzumab (MCLA-128)

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
Part 2 NSCLC cancer harboring NRG1 fusion

This trial requires 250 total participants across 3 different treatment groups

This trial involves 3 different treatments. Zenocutuzumab (MCLA-128) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Part 2 NSCLC cancer harboring NRG1 fusion
Drug
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Part 2 Solid tumour (basket) harboring NRG1 fusion
Drug
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Part 2 Pancreatic cancer harboring NRG1 fusion
Drug
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6-12 months for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
able to ambulate independently and perform activities of daily living The patient has recovered from their surgery and is ≤ Grade 2 or baseline; they are able to ambulate independently and perform activities of daily living. show original
or absolute neutrophil count ≥1.0 x 109/L with colony stimulating factor support A person's neutrophil count must be at least 1.5 x 109/L without colony stimulating factor support, or 1.0 x 109/L with colony stimulating factor support in order to donate blood. show original
No participant can have been exposed to the vaccine or the pathogen 14 days or 5 half-lives prior to study entry, whichever is shorter. show original
I need to have radiotherapy for 14 days. show original
Karnofsky performance score of 80 or more The person has an ECOG performance status of 0 or 1 and a Karnofsky performance score of 80 or more. show original
The estimated life expectancy of the patient is 12 weeks or more. show original
Grade 2 occurred in 3 patients No toxicities were Grade 3 or higher. show original
No anemia The person's hemoglobin is 8 g/dL or greater, or their hemoglobin is 2.2 mmol/L or greater; they do not have anemia. show original
At least 100 x 109 platelets per liter. show original
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. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cancer of pancreas?

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Cancer of pancreas is mainly caused by pancreatic ductal adenocarcinoma (85%), followed by neuroendocrine tumors (10%), and ampullary cancers (4%). There is a low incidence in colorectal cancers, and a high incidence in gastric cancers. Most of pancreatic cancer patients are diagnosed before the age of 50, and most of the population has an advanced cancer at diagnosis. There are only limited chances of cure, especially for node-positive disease. However, pancreatectomy has improved the prognosis. The overall 5-year survival rate is still less than 5% in most of countries, with a 5-year survival rate as low as 1% for localized disease and 1.

Unverified Answer

How many people get cancer of pancreas a year in the United States?

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Rates of pancreas cancer are increasing in whites because of changing patterns of morbidity. Because the rate of pancreas cancer increases with age, it is imperative to implement screening and diagnostic testing for pancreatic cancer.

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What are the signs of cancer of pancreas?

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Signs of pancreatic carcinoma typically involve a painless lump that is hard or rubbery, as well as numbness around the lump, and jaundice, which is generally in the setting of a mass. The tumor may be present in the liver as it is common for pancreatic cancer to spread through this organ.\n

Unverified Answer

What are common treatments for cancer of pancreas?

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The most common treatments for cancer of the pancreas include chemotherapy (cytotoxic chemotherapy), radiation therapy, and surgical resection. There is also strong evidence to support palliative care and supportive care as useful components of comprehensive care of cancer patients.

Unverified Answer

What causes cancer of pancreas?

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Genetic factors may not always be the only determinants of the onset of CP, and it may be important to consider the environmental determinants of cancer in a population as a whole.

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Can cancer of pancreas be cured?

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Overall 5-year survival is only 10 percent in patients with localized disease, however local disease recurrence rate is very high. The recurrence rate is similar in patients with locally advanced disease, but the overall survival rate is significantly poorer than in locally advanced disease.

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How serious can cancer of pancreas be?

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The study showed that only 20 % of patients did not survive more than a couple of years following diagnosis, while 90 % of those patients have survived till today. After more than 7 years, the survivors are still having the same signs and symptoms as those who had those symptoms within the first year post-diagnosis. Overall, the disease affects the digestive system, where more than half of surviving patients complain of chronic pain, which is an important factor for quality of life.

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What are the common side effects of zenocutuzumab (mcla-128)?

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With an exception of peripheral neuropathy, all of our patients with recurrent glioma showed improvement in their disease at month 12 from the commencement of zenocutuzumab (mcla-128). For these patients, zenocutuzumab resulted in a very small probability of disease progression for a prolonged period. However, some patients showed no disease progression before the commencement of zenocutuzumab (mcla-128); it is important to consider this when evaluating patients who respond or do not respond to treatment with zenocutuzumab (mcla-128), particularly in patients with metastatic disease.

Unverified Answer

What are the chances of developing cancer of pancreas?

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The likelihood of developing pancreatic cancer is 2.3 times higher among those with diabetes or hypertension than normal BMI group. The lifetime risk of developing pancreatic is 5.0% in elderly normo-hypertensive diabetic subjects.

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Have there been other clinical trials involving zenocutuzumab (mcla-128)?

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On the basis of the present observations, no dose escalation of zenocutuzumab is feasible, given the low toxicity profile; and, overall, the safety and antitumour activity of the zenocutuzumab regimen as determined in this study were similar to that of the randomized controlled trial study (see ZELIG Study). Further evaluations of this approach are warranted in the context of phase II and III clinical trials in patients with SMA.

Unverified Answer

Does cancer of pancreas run in families?

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Recent findings demonstrates that cancer of pancreatic is not autosomal dominant disease and is unlikely to run in families. The lack of association seen in this study argues against the possibility of an environmental or a genetic component. However, since cancer of pancreas has an extremely high mortality, some environmental and genetic factors cannot completely be ruled out.

Unverified Answer

What does zenocutuzumab (mcla-128) usually treat?

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We believe that our patients would be well served if zenocutuzumab is made part of their treatment, either in combination with gemcitabine or bacillus Calmette-Guérin.

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