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NCT06835569 | RECRUITING | Cancer

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

Alterome Therapeutics, Inc.

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.

Condition or disease

Cancer

PDAC - Pancreatic Ductal Adenocarcinoma

NSCLC (Non-small Cell Lung Cancer)

CRC (Colorectal Cancer)

Advanced Solid Tumors

Intervention/treatment

ALTA3263

cetuximab

Phase

PHASE1

Detailed Description:

This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Study Type : INTERVENTIONAL
Estimated Enrollment : 188 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
Actual Study Start Date : 2025-03-05
Estimated Primary Completion Date : 2029-05
Estimated Study Completion Date : 2029-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

Location Details

NCT06835569

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Research Site

Orlando, florida, United States, 32827

RECRUITING

United States, Massachusetts

Research Site

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Research Site

Boston, Massachusetts, United States, 02115

RECRUITING

United States, New York

Research Site

New York, New York, United States, 10016

RECRUITING

United States, New York

Research Site

New York, New York, United States, 10032

RECRUITING

United States, Tennessee

Research Site

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Research Site

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Research Site #2

Saint Anthony, Texas, United States, 78229

RECRUITING

United States, Texas

Research Site

Saint Anthony, Texas, United States, 78229

RECRUITING

United States, Virginia

Research Site

Fairfax, Virginia, United States, 22031