First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Plexium, Inc.
Study ID
NCT07284186
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Esophageal Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma
  • Gastric Adenocarcinoma
  • Gastric Squamous Cell Carcinoma
  • Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Gastroesophageal Junction Squamous Cell Carcinoma
  • Metastatic Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • SMARCA4 Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PLX-61639 — DRUG
    Orally available degrader of SMARCA2

Study Details

A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed/refractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies. The study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase. Participants will receive their assigned dose of PLX-61639 administered orally, once daily until progression/relapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.

Key Dates

Start date
Dec 1, 2025
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
155 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PLX-61639

Primary Outcome Measure

Treatment Emergent Adverse Events [ Time Frame: From enrollment to 28 days after the last dose of PLX-61639 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85258-
Research SiteDuarteCalifornia91010-
Research SiteOrangeCalifornia92868-
Research SiteBostonMassachusetts02114-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10044-
Research SiteDurhamNorth Carolina27710-
Research SiteClevelandOhio44106-
Research SiteSan AntonioTexas78229-
Research SiteFairfaxVirginia22031-

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