Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

New Cancer Therapy Trial for Pancreatic, Lung, Breast, and Colorectal Cancers

NCT: NCT06562192 · Status: RECRUITING · Phase: Phase 1 · Sponsor: Novartis Pharmaceuticals · Started: 2024-10-15 · Est. Completion: 2031-01-16

Plain English Summary

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers is a Phase 1 clinical trial sponsored by Novartis Pharmaceuticals studying Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer. This trial tests a new drug called [177Lu]Lu-NNS309, delivered via a radioactive tracer, to see if it's safe and effective in treating advanced or widespread pancreatic, lung, breast, and colorectal cancers. It is for adults (18+) with specific types of these cancers that have not responded to or cannot tolerate standard treatments. Participation involves receiving the study drug, undergoing imaging scans, and regular check-ups to monitor for side effects and treatment response. Alternative treatments may include chemotherapy, immunotherapy, or targeted therapies, depending on the cancer type and previous treatments. The trial aims to enroll 162 participants.

Official Summary

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced or metastatic pancreatic, lung, breast (HR+/HER2- or triple-negative), or colorectal cancer. Patients must have cancer that has progressed after or is intolerant to standard treatments, and their tumors must show uptake of a specific imaging agent ([68Ga]Ga-NNS309). Individuals with very low white blood cell counts, low hemoglobin, low platelet counts, certain heart rhythm abnormalities (QTc interval), or poor kidney function may not be eligible. People who have had radiation therapy recently or have unmanageable urinary issues are also excluded. This trial is studying Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the new drug is by tracking side effects and determining the highest tolerable dose, which is crucial for understanding its potential benefits and risks. The specific primary outcome measures are: Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 (From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule); Incidence and severity of adverse events and serious adverse events of [177Lu]Lu-NNS309 (From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months); Dose modifications for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks); Dose intensity for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial addresses a critical need for new treatments for advanced cancers that have stopped responding to existing therapies, potentially offering a new option for patients with limited alternative This research targets Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer, where improved treatment options are needed.

Investor Insight

This Phase I trial by Novartis is exploring a novel radioligand therapy for a range of common and difficult-to-treat cancers, indicating a significant investment in a potentially innovative treatment Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific type of cancer being studied, the potential benefits and risks of [177Lu]Lu-NNS309, and how it differs from your current treatment. Be prepared for regular visits for drug administration, imaging, blood tests, and physical exams to monitor your health and the cancer's response. Understand that this is an early-phase trial, meaning its main goal is to assess safety and find the right dose, not necessarily to prove effectiveness yet. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Age ≥ 18 years old
* Patients with one of the following indications:
* Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy
* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy
* Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
* Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
* (Dose escalation part only) Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
* Patients must have lesions showing 68Ga-NNS309 uptake

Exclusion Criteria:

* Absolute neutrophil count (ANC) \< 1.5 x 109/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 109/L
* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
* Creatinine clearance \< 60 mL/min
* Unmanageable urinary tract obstruction or urinary incontinence
* Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-NNS309

Other protocol-defined inclusion/exclusion criteria may apply.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06562192?

NCT06562192 is a Phase 1 INTERVENTIONAL study titled "Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers." It is currently recruiting and is sponsored by Novartis Pharmaceuticals. The trial targets enrollment of 162 participants.

What conditions does NCT06562192 study?

This trial investigates treatments for Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer. The primary condition under study is Pancreatic Ductal Adenocarcinoma.

What treatments are being tested in NCT06562192?

The interventions being studied include: [68Ga]Ga-NNS309 (DRUG), [177Lu]Lu-NNS309 (DRUG). Radioligand imaging agent

What does Phase 1 mean for NCT06562192?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT06562192?

This trial is currently "Recruiting." It started on 2024-10-15. The estimated completion date is 2031-01-16.

Who is sponsoring NCT06562192?

NCT06562192 is sponsored by Novartis Pharmaceuticals. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06562192?

The trial aims to enroll 162 participants. The trial is currently recruiting and accepting new participants.

How is NCT06562192 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06562192?

The primary outcome measures are: Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 (From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule); Incidence and severity of adverse events and serious adverse events of [177Lu]Lu-NNS309 (From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months); Dose modifications for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks); Dose intensity for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06562192 being conducted?

This trial is being conducted at 20 sites, including Birmingham, Alabama; Los Angeles, California; Palo Alto, California; Jacksonville, Florida and 16 more sites (United States, Belgium, Canada).

Where can I find official information about NCT06562192?

The official record for NCT06562192 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06562192. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06562192 testing in simple terms?

This trial tests a new drug called [177Lu]Lu-NNS309, delivered via a radioactive tracer, to see if it's safe and effective in treating advanced or widespread pancreatic, lung, breast, and colorectal cancers. It is for adults (18+) with specific types of these cancers that have not responded to or cannot tolerate standard treatments.

Why is this trial significant?

This trial addresses a critical need for new treatments for advanced cancers that have stopped responding to existing therapies, potentially offering a new option for patients with limited alternative

What are the potential risks of participating in NCT06562192?

Common side effects may include nausea, fatigue, and changes in blood counts, which will be closely monitored. More serious risks could involve damage to healthy organs from radiation, or severe allergic reactions, though these are carefully managed. The treatment involves radiation, so specific precautions may be needed to minimize exposure to others after receiving the drug. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06562192?

Ask your doctor about the specific type of cancer being studied, the potential benefits and risks of [177Lu]Lu-NNS309, and how it differs from your current treatment. Be prepared for regular visits for drug administration, imaging, blood tests, and physical exams to monitor your health and the cancer's response. Understand that this is an early-phase trial, meaning its main goal is to assess safety and find the right dose, not necessarily to prove effectiveness yet. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06562192 signal from an investment perspective?

This Phase I trial by Novartis is exploring a novel radioligand therapy for a range of common and difficult-to-treat cancers, indicating a significant investment in a potentially innovative treatment This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves receiving the study drug, undergoing imaging scans, and regular check-ups to monitor for side effects and treatment response. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Pancreatic Ductal Adenocarcinoma Trials

View all Pancreatic Ductal Adenocarcinoma clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.