Recruiting

Phase 1

ALTA3263A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

Sponsor:

Alterome Therapeutics, Inc.

Code:

NCT06835569

Conditions

Cancer

PDAC - Pancreatic Ductal Adenocarcinoma

NSCLC (Non-small Cell Lung Cancer)

CRC (Colorectal Cancer)

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ALTA3263

cetuximab

mFOLFOX6

Pembrolizumab

Pemetrexed + Cisplatin /Carboplatin

Study Details

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.

Conditions

Cancer

PDAC - Pancreatic Ductal Adenocarcinoma

NSCLC (Non-small Cell Lung Cancer)

CRC (Colorectal Cancer)

Advanced Solid Tumors

Study ID

NCT06835569

Start date

Mar 5, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

448 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALTA3263 monotherapy

ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with cetuximab

ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with mFOLFOX6 plus cetuximab

ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, and oxaliplatin (mFOLFOX6) and cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with pembrolizumab

ALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with pembrolizumab plus chemotherapy

ALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with mFOLFIRINOX

ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with mFOLFIRINOX plus cetuximab

ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with GnP

ALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 in combination with GnP plus cetuximab

ALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment

experimental: ALTA3263 Midazolam DDI Substudy

ALTA3263 and midazolam will be administered at a protocol defined schedule

Interventions

ALTA3263

Oral ALTA3263 tablets will be administered at a protocol-defined dose

cetuximab

Cetuximab injection for IV use will be administered at a protocol-defined dose

mFOLFOX6

modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose

Pembrolizumab

Pembrolizumab injection for IV use will be administered at a protocol-defined dose

Pemetrexed + Cisplatin /Carboplatin

Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose

mFOLFIRINOX

modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose

GnP

gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose

Midazolam

Oral midazolam will be administered at a protocol-defined dose

Primary outcome measure

Adverse Events [ Time Frame: Up to 39 months ]
Dose Limiting Toxicities [ Time Frame: 21 days ]

Central Contacts and Locations

Central contacts

Alterome Clinical Trial Contact Center

619-768-8189 clinical.trials@alterome.com

Locations

Research Site

Recruiting

Orlando, Florida, United States, 32827

Research Site

Recruiting

Boston, Massachusetts, United States, 02114

Research Site

Recruiting

Boston, Massachusetts, United States, 02115

Research Site

Recruiting

St Louis, Missouri, United States, 63110

Research Site

Recruiting

New York, New York, United States, 10016

Research Site

Recruiting

New York, New York, United States, 10032

Research Site

Recruiting

Durham, North Carolina, United States, 27710

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site #2

Recruiting

San Antonio, Texas, United States, 78229

Research Site

Recruiting

San Antonio, Texas, United States, 78229

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Alterome Therapeutics, Inc.

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alterome Therapeutics, Inc. on 2026-06-10.