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A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

RECRUITINGPhase 1Sponsored by Alterome Therapeutics, Inc.
Actively Recruiting
PhasePhase 1
SponsorAlterome Therapeutics, Inc.
Started2025-03-05
Est. completion2029-05
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites

Summary

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
* Unresectable or metastatic disease.
* Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function

Exclusion Criteria:

* Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol
* Known condition that prohibits the ability to swallow or absorb an oral medication.

Other inclusion/exclusion criteria may apply.

Conditions6

Advanced Solid TumorsCRC (Colorectal Cancer)CancerLung CancerNSCLC (Non-small Cell Lung Cancer)PDAC - Pancreatic Ductal Adenocarcinoma

Locations8 sites

Research Site
Orlando, Florida, 32827
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
Research Site
New York, New York, 10016
Research Site
Nashville, Tennessee, 37203

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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