NCT06835569 A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
| NCT ID | NCT06835569 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Alterome Therapeutics, Inc. |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 448 participants |
| Start Date | 2025-03-05 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 448 participants in total. It began in 2025-03-05 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Study Medical Director
STUDY DIRECTOR
Alterome Therapeutics
Frequently Asked Questions
Who can join the NCT06835569 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06835569 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06835569 currently recruiting?
Yes, NCT06835569 is actively recruiting participants. Contact the research team at clinical.trials@alterome.com for enrollment information.
Where is the NCT06835569 trial being conducted?
This trial is being conducted at Orlando, United States, Boston, United States, Boston, United States, St Louis, United States and 8 additional locations.
Who is sponsoring the NCT06835569 clinical trial?
NCT06835569 is sponsored by Alterome Therapeutics, Inc.. The principal investigator is Study Medical Director at Alterome Therapeutics. The trial plans to enroll 448 participants.
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