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RecruitingPhase 1

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

A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of ALTA3263 and how well people can tolerate it. It is for adults with advanced solid tumors that have a change in a gene called KRAS.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a solid tumor cancer confirmed by a tissue test, with a KRAS gene change found by an approved lab test.
  • Have cancer that cannot be removed by surgery or has spread to other parts of the body.
  • Have cancer that got worse after standard treatment, could not tolerate that treatment, or chose not to receive it.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have organs that work well enough for the study.

Who can't join

  • Have had treatment with a KRAS inhibitor, a drug that blocks KRAS. Some exceptions are listed in the full study rules.
  • Have a known condition that keeps you from swallowing or absorbing medicine taken by mouth.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (12)

FL

MA

MO

NC

NY

TN

TX

VA