First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
Recruiting
Phase 1
Interventional Study
Esophageal Squamous Cell Carcinoma
Gastric Adenocarcinoma
Gastric Squamous Cell Carcinoma
Gastroesophageal Junction (GEJ) Adenocarcinoma
Metastatic Solid Tumor
Non-Small Cell Lung Carcinoma
Esophageal Adenocarcinoma
SMARCA4 Mutation
Gastroesophageal Junction Squamous Cell Carcinoma
Advanced Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 155 (estimated)
- Sponsor
- Plexium, Inc. · Industry
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About This Trial
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 (…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies
* Adequate liver bone marrow, coagulat…
Contacts