What this study is
Simplified from ClinicalTrials.govTesting a drug that blocks KRAS, a gene that can be altered in tumors (ETX-929), to learn about its safety and side effects and early signs of whether it works, alone or with other cancer treatments, in adults 18 and older with advanced solid tumors that have a KRAS mutation.
Read the original summary from ClinicalTrials.gov
This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.
What's being tested
- ETX-929 dose escalation
Intervention · DRUG
ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule that will be taken once per day in 21-day cycles, to evaluate escalating dose levels.
- ETX-929 dose escalation in combination with cetuximab
Intervention · DRUG
ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule. ETX-929 will be taken in combination with cetuximab in 28-day cycles, to evaluate escalating dose levels. EXT-929 is an oral capsule that will be taken once per day. Cetuximab will be administered intravenously every two weeks.
Study details
- Official title
- A Phase 1/2, First-in-Human Study of ETX-929, a Pan-KRAS Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With KRAS-Altered Advanced Solid Tumors
- Sponsor
- Ensem Therapeutics
- Conditions
- Metastatic Colorectal Cancer (CRC) · Pancreatic Ductal Adenocarcinoma (PDAC) · Non-squamous, Non-Small Cell Lung Cancer · Endometrial Adenocarcinoma · Ovarian Adenocarcinoma · Primary Peritoneal Carcinoma
- Enrolling
- 320 people
- Starts
- 2026-10-22
- Est. completion
- 2029-04-30
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
- Tumor harboring a KRAS mutation.
- An ECOG performance status score of 0 or 1.
- Adequate organ function.
You can't join if
- Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
- Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
- Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
- Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNEXT
Fairfax, Virginia, United States
- Maybelle De La Rosa · Contact703-783-4518mdelarosa@nextoncology.com
- Alex Spira, MD, PhD, FACP · Principal investigator
Recruiting
Study team
Sponsor
Ensem Therapeutics
Study ID ETX929-C-001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.