PLX-61639 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study the safety and early effectiveness of a new oral treatment, PLX-61639, for people with advanced solid tumors unresponsive to standard therapies. It targets tumors with a specific genetic change called a SMARCA4 mutation. Participants who have tried other treatments without success or cannot tolerate them might be suitable candidates. The treatment will be taken once daily, and the trial will explore the optimal dosage and its effects. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Is there any evidence suggesting that PLX-61639 is likely to be safe for humans?
Research has shown that PLX-61639 is a new treatment being tested for certain solid tumors. It targets a specific protein that some cancer cells require for growth. Lab studies have demonstrated that this treatment can stop cancer cells from multiplying.
Since PLX-61639 is being tested in humans for the first time, limited information exists about its safety for people. The trial is in an early stage, focusing on the treatment's safety and participants' tolerance. Researchers will closely monitor participants for any side effects. Early trials like this are crucial to ensure the treatment does not cause harm before broader testing.
For those considering joining this trial, it is important to understand that the main goal is to assess the treatment's safety. While there might be unknown risks, the trial is designed to identify these while prioritizing participant safety.12345Why do researchers think this study treatment might be promising?
PLX-61639 is unique because it targets solid tumors with a novel mechanism that differs from traditional chemotherapy, which typically attacks rapidly dividing cells. Instead, PLX-61639 is designed to selectively inhibit specific pathways within the tumor cells, potentially leading to fewer side effects and improved targeting. Researchers are excited about PLX-61639 because it offers the possibility of more precise treatment, aiming to disrupt the tumor's growth processes without harming healthy cells, which could enhance both effectiveness and patient quality of life.
What evidence suggests that PLX-61639 might be an effective treatment for solid tumors?
Research has shown that PLX-61639, the investigational treatment in this trial, may help fight certain solid tumors. Early studies found that PLX-61639 significantly slowed tumor growth in specific lung cancers with a SMARCA4 mutation. This suggests the treatment might be effective for tumors with this genetic change. However, it did not affect tumor growth in models without the SMARCA4 mutation, highlighting its targeted action. The drug targets a specific protein that aids cancer cell survival, offering hope for those with limited treatment options.12346
Who Is on the Research Team?
Chief Medical Officer
Principal Investigator
Plexium, Inc.
Are You a Good Fit for This Trial?
This trial is for people with advanced or metastatic solid tumors that are SMARCA4-deficient and have not responded to or can't tolerate approved treatments. It's open to various cancer types, including esophageal, pancreatic, cervical, lung, stomach cancers and more.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PLX-61639 orally, once daily in 28-day cycles until progression, intolerance, or withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PLX-61639
Trial Overview
PLX-61639 is being tested in this study. Participants will take the drug orally once a day across different phases: finding the right dose (escalation), fine-tuning it (optimization), and then expanding to more patients (expansion).
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Plexium, Inc.
Lead Sponsor
Citations
First-in-Human Study of PLX-61639 in Locally Advanced or ...
A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in ...
Preclinical characterization of PLX-61639, a potent and ...
Daily oral dosing of PLX-61639 demonstrates significant tumor growth inhibition in the. SM4mut NSCLC CDX models, NCI-H1568 (B) and NCI-H1573 (C). Tumors excised ...
3.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_1/1653/757043/Abstract-1653-Preclinical-characterization-of-PLXPreclinical characterization of PLX-61639, a potent and orally ...
PLX-61639 had no impact on tumor growth using a SMARCA4WT xenograft model, supporting the dependency of SMARCA4 mutational status for SMARCA2- ...
4.
ctv.veeva.com
ctv.veeva.com/study/first-in-human-study-of-plx-61639-in-locally-advanced-or-metastatic-solid-tumorsFirst-in-Human Study of PLX-61639 in Locally Advanced or ...
A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 ...
PLX-61639 - Drug Targets, Indications, Patents
100 Clinical Results associated with PLX-61639. Login to view more data. 100 Translational Medicine associated with PLX-61639. Login to view more data.
Prognostic Implications of SMARCA4 , ARID1A , and Other ...
IND approved, SMARCA4‐mutated cancers, Unknown, Not applicable. PLX‐61639 ... Solid Tumors to PD‐1 Blockade,” Science 357, no. 6349 (2017): 409 ...
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