A Phase I/II, 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

Study Identifier:
ETX929-C-001
CT.gov Identifier:
NCT07912593
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Part A Dose Escalation Monotherapy
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Drug: Part A will evaluate escalating doses of ETX-929 as monotherapy in participants with advanced solid tumors. Part B will evaluate escalating doses of ETX-929 as combination therapy with fixed dose cetuximab in participants. Part C and Part D will expand enrollment of ETX-929 as monotherapy and in combination with cetuximab at the recommended doses from escalation.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • Inclusion Criteria:
  • * 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.
Exclusion criteria
  • Exclusion Criteria:
  • * 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Will Be Recruiting
Condition(s) Treated at Site
Solid Tumor