265 Participants NeededMy employer runs this trial

BLU-924 for Cancer

Recruiting at 2 trial locations
BM
Overseen ByBlueprint Medicines
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Blueprint Medicines Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BLU-924, an experimental therapy for certain advanced cancers, specifically pancreatic, non-small cell lung, and colorectal cancers with a specific KRAS gene mutation. Researchers aim to assess the safety and effectiveness of this treatment and its impact on tumors. Individuals with these advanced cancers and KRAS mutations, who have exhausted all standard treatments, might be suitable candidates for this study. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BLU-924 is likely to be safe for humans?

Research has shown that BLU-924, a drug targeting KRAS mutations, has a promising safety record. In studies involving patients with lung and pancreatic cancer, only 10% experienced serious side effects related to the treatment, suggesting that most patients tolerate it well.

Researchers are testing BLU-924 to determine its safety and effectiveness for people with certain cancers that have KRAS mutations. These mutations can make cancer more aggressive and difficult to treat. The treatment specifically targets these mutations.

Although any new treatment carries risks, the low rate of serious side effects in earlier studies is encouraging. This information may assist those considering joining a trial in deciding if it feels right for them.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about BLU-924 because it targets specific cancer cells with KRAS mutations, which are commonly found in cancers like pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). Unlike traditional chemotherapy that attacks both healthy and cancerous cells, BLU-924 is designed to be more selective, potentially reducing side effects and enhancing effectiveness. Additionally, BLU-924 is taken as an oral tablet, offering a convenient alternative to infusions or injections that are typical with many cancer treatments. This innovative approach could offer new hope for patients with these challenging cancers.

What evidence suggests that BLU-924 might be an effective treatment for advanced cancer with KRAS mutations?

Studies have shown that cancers with KRAS mutations, such as pancreatic, lung, and colorectal cancer, often result in worse outcomes. KRAS mutations cause cancer cells to grow uncontrollably. In this trial, participants will receive BLU-924, designed to target these mutations and potentially stop or slow the cancer's growth. Although limited information exists from human studies, this treatment aims to block the signals that allow cancer to spread. Early research suggests that targeting KRAS mutations may improve patient outcomes.12367

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic, non-small cell lung, or colorectal cancer that have a KRAS gene mutation. Participants should have already tried standard treatments and still have cancer that has grown or spread.

Inclusion Criteria

I have metastatic cancer with a KRAS mutation confirmed by testing.
I am fully active or restricted in physically strenuous activity only.
I have received all standard treatments for my cancer unless I couldn't for medical reasons.
See 1 more

Exclusion Criteria

I have had another cancer within the past 2 years.
I have active brain metastases, but I may be eligible if they do not cause symptoms.
I do not have any active or uncontrolled serious infections like TB, Hepatitis, or HIV.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BLU-924 oral tablet once daily to evaluate dose limiting toxicities and determine the maximum tolerated dose

Duration not specified

Dose Enrichment

Participants receive BLU-924 at selected dose levels to further characterize safety, pharmacokinetics, and preliminary clinical activity

Duration not specified

Dose Expansion

Participants receive the recommended dose for expansion to assess safety, antitumor activity, pharmacokinetics, and pharmacodynamics

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • BLU-924 (SAR449336)

Trial Overview

The study is testing BLU-924 (SAR449336), a new drug designed to target cancers with KRAS mutations. It aims to find the safest dose and see how well the drug works in people whose tumors carry these mutations.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Monotherapy Part: BLU-924 Dose Escalation, Dose Enrichment, and Dose ExpansionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Blueprint Medicines Corporation

Lead Sponsor

Trials
31
Recruited
6,000+

Sanofi

Industry Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

A First-in-Human Trial of BLU-924 (SAR449336) ...

A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 / SAR449336, a pan-KRAS ...

A First-in-Human Trial of BLU-924 (SAR449336) in Advanced ...

A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 / SAR449336, a pan-KRAS ...

KRAS Mutation Status and Treatment Outcomes in Patients ...

In this cohort study of 2433 patients, those with KRAS G12D or G12V mutations had a significantly higher risk of disease progression.

A First-in-Human Trial of BLU-924 (SAR449336) ...

A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 / SAR449336, a pan-KRAS inhibitor, ...

News - KRAS G12S

The uncommon KRAS mutation group had numerically inferior progression-free survival (PFS) and overall survival (OS); however, this difference ...

Evaluation of KRAS inhibitor-directed therapies for pancreatic ...

Of the clinically evaluable PDAC patients, only 10% of lung and pancreas cancer patients experienced grade 3-4 TRAEs. This impressive safety profile is ...

RMC-9805 Triggers Tumor Regressions in KRAS G12D– ...

RMC-9805 was proven safe and active in patients with previously treated, KRAS G12D–mutant pancreatic ductal adenocarcinoma.