RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing ETX-929 dose escalation for Metastatic Colorectal Cancer (CRC)

This is a Phase 1/2, open-label, multi-center study to measure the safety, tolerability, PK, PD, and preliminary how well it works of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.

Official registry: https://clinicaltrials.gov/study/NCT07912593 · Ensem Therapeutics · enrollment listed as 320

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ETX-929 dose escalation, or ETX-929 dose escalation in combination with cetuximab. The registry lists allocation as randomized. This is a Phase 1/2, open-label, multi-center study to measure the safety, tolerability, PK, PD, and preliminary how well it works of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.

They plan to enroll about 320 people at Fairfax. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ETX-929 dose escalation, ETX-929 dose escalation in combination with cetuximab

Primary outcome (registry wording): Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B

Who it is for (from inclusion criteria)

Ages 18 Years to any
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 how well you can do daily activities (ECOG score) score of 0 or 1
Adequate organ function

Who the registry excludes

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

Public study contact (from the registry)

Lori Cykowski

1-617-383-4993

lori.cykowski@Ensemtx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

NEXT — Fairfax, Virginia (recruiting)

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FAQ about this NCT record

Is NCT07912593 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07912593?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07912593?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary