Clinical trial NCT06835569: A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Official title: A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cancer
PDAC - Pancreatic Ductal Adenocarcinoma
NSCLC (Non-small Cell Lung Cancer)
CRC (Colorectal Cancer)
Advanced Solid Tumors
Keywords: KRAS mutation
NSCLC
Non-small cell lung cancer
Colorectal cancer
Pancreatic ductal adenocarcinoma
Colorectal carcinoma
Pancreatic cancer
Pancreatic carcinoma
Solid tumors
KRAS
Mutation
Metastatic
Advanced unresectable
Neoplasms
Neoplasms by Site
Carcinoma
Non-small cell lung carcinoma
Non-small cell lung neoplasm
Pancreatic neoplasm
Lung neoplasm
Colorectal neoplasm
Colon neoplasm
Mutant KRAS
KRAS amplification
Lead sponsor: Alterome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

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.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 39 months
measure: Dose Limiting Toxicities
timeFrame: 21 days
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
measure: Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
timeFrame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
measure: Terminal Half-Life (t1/2)
timeFrame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose
measure: Objective Response Rate (ORR)
timeFrame: Up to 39 months
measure: Duration of Response (DOR)
timeFrame: Up to 39 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 39 months
measure: Overall Survival (OS)
timeFrame: Up to 39 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Fairfax
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Alterome Therapeutics
name: Study Medical Director
role: STUDY_DIRECTOR
References: