BLU-451 for Antineoplastic Agents

Phase-Based Estimates
1
Effectiveness
1
Safety
New Experimental Therapeutics of Virginia (NEXT Oncology), Fairfax, VA
+19 More
BLU-451 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Antineoplastic Agents

Study Summary

Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Neoplasms by Histologic Type
  • Carcinoma, Bronchogenic
  • Respiratory Tract Neoplasms
  • Lung Cancer
  • Lung Diseases
  • Adenocarcinoma
  • Neoplasms by Site
  • Cancer
  • Bronchial Neoplasms
  • Neoplasms, Nerve Tissue
  • Respiratory Tract Diseases
  • Carcinoma
  • Antineoplastic Agents
  • Lung Neoplasm Malignant
  • EGFR Gene Mutation Exon 20
  • Lung Neoplasms
  • EGFR Activating Mutation
  • EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance
  • EGFR Exon 20 Insertion Mutation
  • Neoplasms
  • Metastatic Lung Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether BLU-451 will improve 4 primary outcomes and 17 secondary outcomes in patients with Antineoplastic Agents. Measurement will happen over the course of Up to 30 months.

12-15 Months
Phase I & II - The Clinical Benefit Rate (CBR) of BLU-451
Phase I & II - The Disease Control Rate (DCR) rate of BLU-451
Phase I & II - The Duration of Response (DOR) rate of BLU-451
Phase I & II - The Overall Survival (OS) rate of BLU-451
Phase I & II - The Progression Free Survival (PFS) rate of BLU-451
Phase I - Assess treatment-induced modulation of EGFR pathway biomarkers
Phase I - Determine the Recommended Phase 2 Dose (RP2D) of BLU-451
Phase I - Determine the maximum tolerated dose (MTD) of BLU-451
Phase I - Rate and severity of Adverse Events (AEs) of BLU-451
Up to 30 months
Phase I & II - To evaluate the Central Nervous System (CNS) Duration of Response (DOR) of BLU-451 in subjects with measurable baseline brain metastases
Phase I & II - To evaluate the Central Nervous System (CNS) Overall Response Rate (ORR) of BLU-451 in subjects with measurable baseline brain metastases
Phase I & II - To evaluate the Central Nervous System (CNS) Progression Free Survival (PFS) of BLU-451 in subjects with measurable baseline brain metastases
Phase I & II - To evaluate the area under the blood concentration-time curve (AUC0-t, AUC0-inf) of BLU-451
Phase I & II - To evaluate the clearance (CL/F) of BLU-451
Phase I & II - To evaluate the elimination half life (t1/2) of BLU-451
Phase I & II - To evaluate the maximum observed blood drug concentration (Cmax) of BLU-451
Phase I & II - To evaluate the time of maximum blood concentration (tmax) of BLU-451
Phase I & II - To evaluate the volume of distribution (Vss/F) of BLU-451
Phase I - The Overall Response Rate (ORR) rate of BLU-451
Phase II - Rate and severity of Adverse Events (AEs) of BLU-451
Phase II - The Overall Response Rate (ORR) rate of BLU-451

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Phase II - Dose Expansion

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. BLU-451 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Phase II - Dose Expansion
Drug
Oral dose of BLU-451 at the dose determined during Dose Escalation
Phase I - Dose Escalation
Drug
Multiple doses of BLU-451 for oral administration

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12-15 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12-15 months for reporting.

Closest Location

New Experimental Therapeutics of Virginia (NEXT Oncology) - Fairfax, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Antineoplastic Agents or one of the other 19 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have metastatic NSCLC stage IVA or IVB per AJCC 8th Edition (Phase 1 and Phase 2) or other metastatic cancers except for primary CNS tumors (Phase 1 only). show original
Males & females age ≥ 18 years at time of signing the informed consent document.
For Phase 1 only, cancers with EGFR Exon 18 G719X or Exon 21 L861Q mutation that have failed standard of care therapy, are eligible with Sponsor approval. Other EGFR mutations (e.g., L858R or Exon 19 deletion) may be eligible if T790M mutation is not present and at least 1 EGFR TKI was tried and failed and if approved by the Sponsor Medical Monitor.
You have EGFR exon 20ins based on NGS testing of tumor or liquid biopsy. show original
° Platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy is contraindicated.
° Prior treatment with at least 1 prior line of EGFR Ex20ins-targeted therapy is allowed but not required. EGFR Ex20ins targeted therapy includes amivantamab or mobocertinib. Other agents including investigational EGFR Ex20ins-targeted therapy or other approved EGFR-targeted TKIs are allowed with Sponsor Medical Monitor approval.
Prior ICI (e.g., programmed cell death protein 1 [PD-1] or PD-L1 inhibitors) are allowed but not required. If a patient with NSCLC has not received a prior ICI, documentation must be provided in the medical record or informed consent that this has been discussed as a therapeutic option.
Any approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient.
Platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy is contraindicated.
Prior ICI (e.g., PD-1 or PD-L1 inhibitors) are allowed but not required. If a patient with NSCLC has not received a prior ICI, documentation must be provided in the medical record or informed consent that this has been discussed as a therapeutic option.

Patient Q&A Section

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

Can respiratory tract neoplasms be cured?

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Respiratory tract cancer presents as a heterogeneous group of malignancies including many different histology. Lung cancer is the most common diagnosis at presentation due to its high prevalence. Although many therapeutic strategies have been adopted over the years, with excellent disease control, it is still associated with unfavorable long term prognosis. In the present study, we have analyzed the clinicopathological features in patients. We have found that some independent prognostic factors are possible factors for better disease-specific survival and good disease control. However, the current therapeutics have failed to cure this disease. Our finding can be used as a basis to develop new therapeutic strategies for these patients in future.

Unverified Answer

How many people get respiratory tract neoplasms a year in the United States?

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The United States has a significant burden of respiratory tract cancers; therefore, a major public health problem must be considered in light of its potentially high economic costs. The lifetime prevalence of all types of cancer in the United States, combined with their increased incidence in the first decade of life, indicates that the number of cancers diagnosed may escalate rapidly over the next decade.

Unverified Answer

What causes respiratory tract neoplasms?

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Neoplasms are a huge and growing risk for people with COPD. Patients with COPD should be informed of the possibility of developing respiratory tract neoplasms. Neoplasms of the lung, esophagus, stomach and cervix should be looked for in COPD. If found, they are treated with the same standard therapies as non-COPD patients.

Unverified Answer

What is respiratory tract neoplasms?

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Respiratory tract neoplasms most commonly develop from basal cell carcinoma, but may appear for many different reasons, each with their own set of risks and treatment options. These include lung cancer due to small-cell lung carcinoma, squamous-cell carcinoma, adenocarcinoma, carcinoid tumors, lepidic-type carcinoid tumors, bronchioloalveolar carcinoma, lung carcinoid tumors, and mixed subtypes.

Unverified Answer

What are common treatments for respiratory tract neoplasms?

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There is no evidence to indicate a particular treatment for these cancerous (benign) lesions. The primary focus and attention should be directed toward the prevention component, since this is the most plausible avenue that exists for treatment. Tobacco cessation should be aggressively promoted and managed.

Unverified Answer

What are the signs of respiratory tract neoplasms?

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Some signs of respiratory tract neoplasms include cough, dyspnea, chest pain, dysphagia, hemoptysis and anemia. Other signs have been described in the literature, but are not as common. Physicians should be aware that multiple signs that are nonspecific, and occur rarely, are helpful.

Unverified Answer

Have there been any new discoveries for treating respiratory tract neoplasms?

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While several treatments are available to treat respiratory tract tumors, the incidence is still not on the decline in the past decade (1970s). Recent advances in lung-directed radiation therapy are an example of how the field of radiotherapy is slowly making a mark on oncology. The radiopharmaceuticals used for the treatment include yttrium-90 and gallium. While both treatments have shown effectiveness or proof in preliminary investigations, clinical research is still underway to explore whether yttrium and gallium are indeed superior in treating and controlling respiratory tract tumors.

Unverified Answer

Does blu-451 improve quality of life for those with respiratory tract neoplasms?

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Blu- 451 was well tolerated and significantly improved quality of life in this study. Patients reported significant pain relief and more than 70% reported feeling better. Data from a recent study further support the use of Blu- 451 in patients with respiratory tract neoplasms, including those with SCC.

Unverified Answer

Who should consider clinical trials for respiratory tract neoplasms?

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It seems that there is a better understanding of respiratory tract tumors and that appropriate endoscopic, imaging, and histopathologic correlation may improve treatment outcomes. Clinical trials should be more aggressive in trials for sarcomas and nonsmall cell lung carcinomas, if they can be justified. Lung cancer trials might be warranted in small non-[small cell lung cancer](https://www.withpower.com/clinical-trials/small-cell-lung-cancer) and lung metastases of small cell lung cancer, although with limited results.

Unverified Answer

What is blu-451?

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Blu-451 provides a novel mechanism for antiangiogenic activity by inducing autophagy/macrophages apoptosis and microvesicles shedding. Blu-451 may have a potential utility in anti-cancer therapy. The antitumor activity may be due to its antiangiogenic role.

Unverified Answer

Is blu-451 typically used in combination with any other treatments?

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In a recent study, findings demonstrates a significant change in the overall survival rate of our patients when they were switched to the use of 5-FU and CDDP. This change of combination was not attributed to the change in chemotherapeutic regimens used.

Unverified Answer

Is blu-451 safe for people?

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Oral administration of BTX-A was not associated with any adverse events in a group of subjects with moderate to severe allergic asthma, and no clinical or laboratory tests (i.e., blood counts, clotting tests, and urinalysis) showed any significant changes. Thus, BTX-A is a safe, effective topical treatment in people with moderate to severe allergic asthma and is therefore suitable for studies in such individuals.

Unverified Answer
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