CLINICAL TRIAL

M1069 for Cancer

Recruiting · 18+ · All Sexes · Toronto, Canada

First in Human Study of M1069 in Advanced Solid Tumors

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About the trial for Cancer

Eligible Conditions
Neoplasms · Metastatic or Locally Advanced Unresectable Solid Tumors

Treatment Groups

This trial involves 2 different treatments. M1069 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
M1069
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at Screening
Fresh tumor biopsies mandatory for participants at Dose level 2 (DL2) and 6 participants upon potential determination of Recommended Dose for Expansion (RDE). Providing consent to fresh tumor biopsies taken during the Screening period and an on-treatment biopsy is mandatory
Life expectancy of at least 12 weeks according to Investigator judgement
Measurable disease according to RECISTv1.1
Other protocol defined inclusion criteria could apply
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Time from first dose of study drug up to planned assessment at 18.2 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Time from first dose of study drug up to planned assessment at 18.2 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether M1069 will improve 1 primary outcome and 7 secondary outcomes in patients with Cancer. Measurement will happen over the course of Baseline, Cycle 2 Day 15 (each cycle is of 21 days).

Change from Baseline in Tumor Microenvironment (TME) in Available Paired Tumor Biopsies at Cycle 2 Day 15
BASELINE, CYCLE 2 DAY 15 (EACH CYCLE IS OF 21 DAYS)
Change from Baseline in Corrected QT (QTc) Interval Over Time
PRE-DOSE (BASELINE) UP TO 8 HOURS POST-DOSE ON CYCLE 1 DAY 1 AND CYCLE 1 DAY 8 (EACH CYCLE IS OF 21 DAYS)
Pharmacokinetic (PK) Plasma Concentrations of M1069
PRE-DOSE UP TO 24 HOURS POST-DOSE ON CYCLE 1 DAY 1 AND CYCLE 1 DAY 8 (EACH CYCLE IS OF 21 DAYS)
Pharmacodynamic Assessment by Phosphorylated cAMP Response Element-binding Protein (pCREB) Level in ex-vivo Stimulated Blood
PRE-DOSE UP TO 8 HOURS POST-DOSE ON CYCLE 1 DAY 1 AND CYCLE 1 DAY 8; PRE-DOSE ON CYCLE 2 DAY 1 (EACH CYCLE IS OF 21 DAYS)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as Assessed by Investigator
TIME FROM FIRST DOSE OF STUDY DRUG UP TO PLANNED ASSESSMENT AT 18.2 MONTHS
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as Assessed by Investigator
TIME FROM FIRST DOSE OF STUDY DRUG UP TO PLANNED ASSESSMENT AT 18.2 MONTHS
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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 metastatic or locally advanced unresectable solid tumors?

The term 'advanced' refers to tumors with metastatic or locally advanced characteristics, such as distant spread, infiltration of extra- and/or subcutaneous tissue, involvement of bone or regional lymph nodes, or involvement of the CNS or the peritoneum.

Anonymous Patient Answer

Can metastatic or locally advanced unresectable solid tumors be cured?

A subset of metastatic/local recurrences can be surgically removed. In patients with unresectable metastases or locally advanced recurrences, more aggressive treatments are often needed, but even in such extreme cases, the long-term disease-free survival rate with such treatments exceeds 50% and is similar to the long-term disease-free survival rate with non-surgical therapy.

Anonymous Patient Answer

What are common treatments for metastatic or locally advanced unresectable solid tumors?

Patient survival is poor for most patients with metastatic tumor types. Survival for patients with melanoma and [small cell lung cancer](https://www.withpower.com/clinical-trials/small-cell-lung-cancer) is better than expected. Patient survival is poor for almost all patients with locally advanced tumors. Very poorly differentiated (histologically) aggressive tumors with rapid tumor growth are associated with poor outcome, whereas well differentiated tumors with a more indolent growth pattern may result in longer survival. A more aggressive approach may be recommended for these patients.

Anonymous Patient Answer

What are the signs of metastatic or locally advanced unresectable solid tumors?

Findings from a recent study shows that the presence of cancer-related symptoms often has an impact on the patient's willingness to receive more aggressive treatment, which might be unnecessary. In addition, patients without signs of cancer often have a poor prognosis.

Anonymous Patient Answer

What causes metastatic or locally advanced unresectable solid tumors?

Most patients with multiple solid malignancies are affected by a systemic disease at diagnosis. In a significant percentage of patients, metastatic or locally advanced unresectable solid tumors cause the diagnosis of multiple solid malignancies and/or the death of the patient. Patients with multiple solid malignancies present with an increased probability of dying of metastatic or locally advanced unresectable solid tumors. The present study suggests the need to discuss the issue of multiple solid malignancy or multiple solid tumors with metastatic or locally advanced unresectable solid tumors as an integrated and comprehensive management strategy.

Anonymous Patient Answer

How many people get metastatic or locally advanced unresectable solid tumors a year in the United States?

The most common secondary site for secondary disease in metastatic tumors in patients with unresectable, localized disease is liver. The most common site of metastatic disease in patients with locally advanced unresectable tumors is bone. A minority of patients have secondary disease in other sites. Patients diagnosed with metastatic or locally unresectable tumors may have secondary disease in up to three organs.

Anonymous Patient Answer

Is m1069 typically used in combination with any other treatments?

The use of the m1069 as a treatment modality in the absence of other treatments in patients who have locally advanced or metastatic pancreatic cancer, can produce an active and durable remission in about half of the patients.

Anonymous Patient Answer

Does metastatic or locally advanced unresectable solid tumors run in families?

We conclude that the incidence of metastasis or locally advanced unresectable solid tumors in cancer-prone families is higher than expected; this may have arisen from familial aggregation of metastatic or locally advanced solid tumors. This familial aggregation will be most pronounced in cancer-prone families with multiple family members affected by metastatic or locally advanced non-small-cell lung cancer.

Anonymous Patient Answer

Have there been other clinical trials involving m1069?

We hypothesize that this promising drug, being non-toxic and inexpensive, has a good safety profile if injected systematically. Its role as a salvage therapy may be discussed further in specific centers where m1069 has recently been granted marketing authorization, such as the Netherlands.

Anonymous Patient Answer

What is the latest research for metastatic or locally advanced unresectable solid tumors?

The overall outlook and prognosis of this group of patients is very poor. A multi-institution, multi-center, multi-faceted program may be necessary to conduct clinical investigations and new treatments, as well as to better understand the biological nature of this devastating disease.

Anonymous Patient Answer

How does m1069 work?

Data from a recent study has shown a strong correlation between overexpression of VLA-IV and increased lymphatic vessel density and metastatic dissemination or recurrence in metastatic melanoma patients. It has also indicated a correlation between the expression levels of VLA-IV and the size of tumor transplants transplanted into the foot pads of mice. These in vivo data suggest that VLA-IV, similarly to M1069 (also known as VLA-4), might mediate the extravasation of melanoma cells into the lymphatic vessels. Therefore, we conclude that VLA-IV may facilitate melanoma metastasis and may serve as an attractive target for novel treatment modalities and diagnostics.

Anonymous Patient Answer

What is m1069?

In a recent study, findings indicate that the m1069 protein is highly enriched in the nuclear fraction of carcinoma cells compared with normal tissue and is almost exclusively expressed in neoplasia. Therefore, the m1069 protein may facilitate the differentiation of malignant from benign tumors and the identification of tumor cells.

Anonymous Patient Answer
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