A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

New trial for advanced lung cancer with specific genetic marker

NCT: NCT06333951 · Status: RECRUITING · Phase: Phase 1 · Sponsor: Amgen · Started: 2024-09-17 · Est. Completion: 2031-10-27

Plain English Summary

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). is a Phase 1 clinical trial sponsored by Amgen studying Thoracic Tumors, Non-small Cell Lung Cancer. This trial tests a new drug called Anvumetostat, alone or with other cancer treatments, for advanced thoracic tumors. It is for adults with specific types of lung cancer (thoracic tumors) that have a particular genetic change called homozygous MTAP-deletion. Participation involves taking study drugs, having regular medical check-ups, and providing tumor tissue samples. Alternative treatments may include standard chemotherapy, radiation, or immunotherapy, depending on the specific cancer type and previous treatments. The trial aims to enroll 500 participants.

Official Summary

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 or older with advanced thoracic tumors (including non-small cell lung cancer) and a confirmed homozygous MTAP-deletion. Patients must have measurable disease and be able to swallow pills. Individuals with certain heart or lung conditions, a history of organ transplant, or recent major surgery or radiation may not be eligible. Those who have previously received treatment with similar drugs (MAT2A or PRMT5 inhibitors) are excluded. This trial is studying Thoracic Tumors, Non-small Cell Lung 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 and what the highest tolerable dose is, meaning doctors will closely monitor for side effects to ensure patient safety. The specific primary outcome measures are: Number of Participants Experiencing Dose Limiting Toxicities (DLT) (Up to approximately 21 days); Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) (Up to approximately 3 years); Number of Participants Experiencing Serious Adverse Events (SAE) (Up to approximately 3 years). 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 gap in treatment for thoracic tumors with a specific genetic deletion (MTAP-deletion), offering a potential new therapy for patients with limited options. This research targets Thoracic Tumors, Non-small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a specific genetic mutation in lung cancer, a large market, and represents an investment in novel targeted therapies with potential for significant patient benefit if successful. 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 subprotocol you might qualify for and the potential benefits and risks. Be prepared for regular clinic visits for drug administration, blood tests, and imaging scans to monitor your condition. Understand that participation requires providing tumor tissue, either from a past biopsy or a new one. 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

Subprotocol A, B, and C

* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
* Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing.
* Homozygous MTAP-deletion
* Able to swallow and retain PO administered study treatment.
* Disease measurable as defined by RECIST v1.1.

Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.

Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab):

\- Predominantly squamous histology.

Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab):

\- Predominantly non-squamous histology.

Arm C (Anvumetostat + pembrolizumab):

\- PD-L1 positive.

Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.

Subprotocol C

* Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
* Brain lesion meeting RANO-BM criteria for measurable disease.

Exclusion Criteria

Subprotocol A, B, and C

* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
* Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
* History of solid organ transplant.
* Major surgery within 28 days of first dose of Anvumetostat.
* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
* Radiation therapy within 28 days of first dose.

Subprotocol A

\- Autoimmune disease or immunodeficiency disease as defined in the protocol'

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06333951?

NCT06333951 is a Phase 1 INTERVENTIONAL study titled "Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).." It is currently recruiting and is sponsored by Amgen. The trial targets enrollment of 500 participants.

What conditions does NCT06333951 study?

This trial investigates treatments for Thoracic Tumors, Non-small Cell Lung Cancer. The primary condition under study is Thoracic Tumors.

What treatments are being tested in NCT06333951?

The interventions being studied include: Anvumetostat (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG), Pembrolizumab (DRUG), Pemetrexed (DRUG). Administered PO

What does Phase 1 mean for NCT06333951?

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 NCT06333951?

This trial is currently "Recruiting." It started on 2024-09-17. The estimated completion date is 2031-10-27.

Who is sponsoring NCT06333951?

NCT06333951 is sponsored by Amgen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06333951?

The trial aims to enroll 500 participants. The trial is currently recruiting and accepting new participants.

How is NCT06333951 designed?

This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06333951?

The primary outcome measures are: Number of Participants Experiencing Dose Limiting Toxicities (DLT) (Up to approximately 21 days); Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) (Up to approximately 3 years); Number of Participants Experiencing Serious Adverse Events (SAE) (Up to approximately 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06333951 being conducted?

This trial is being conducted at 20 sites, including Bakersfield, California; Duarte, California; Los Angeles, California; Orange, California and 16 more sites (United States).

Where can I find official information about NCT06333951?

The official record for NCT06333951 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06333951. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06333951 testing in simple terms?

This trial tests a new drug called Anvumetostat, alone or with other cancer treatments, for advanced thoracic tumors. It is for adults with specific types of lung cancer (thoracic tumors) that have a particular genetic change called homozygous MTAP-deletion.

Why is this trial significant?

This trial addresses a gap in treatment for thoracic tumors with a specific genetic deletion (MTAP-deletion), offering a potential new therapy for patients with limited options.

What are the potential risks of participating in NCT06333951?

Common side effects may include fatigue, nausea, and changes in blood counts. More serious risks can involve severe allergic reactions, heart problems, or lung inflammation. The study will closely monitor for and manage any adverse events that occur. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06333951?

Ask your doctor about the specific subprotocol you might qualify for and the potential benefits and risks. Be prepared for regular clinic visits for drug administration, blood tests, and imaging scans to monitor your condition. Understand that participation requires providing tumor tissue, either from a past biopsy or a new one. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06333951 signal from an investment perspective?

This trial targets a specific genetic mutation in lung cancer, a large market, and represents an investment in novel targeted therapies with potential for significant patient benefit if successful. 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 taking study drugs, having regular medical check-ups, and providing tumor tissue samples. 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.

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