CancerPhase 1NCT06835569
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
A Phase 1 study testing ALTA3263, cetuximab and mFOLFOX6 in people with Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by Alterome Therapeutics, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- ALTA3263, cetuximab and mFOLFOX6
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 14 sitesUnited States
- Study dates
- 5 Mar 2025to Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Research Site
Boston, Massachusetts, 02114
- Recruiting
Research Site
Boston, Massachusetts, 02115
- Recruiting
Research Site
Durham, North Carolina, 27710
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Houston, Texas, 77030
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Recruiting
Research Site
New York, New York, 10016
- Recruiting
Research Site
New York, New York, 10032
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Orlando, Florida, 32827
- Recruiting
Research Site #2
San Antonio, Texas, 78229
- Recruiting
Research Site
San Antonio, Texas, 78229
- Recruiting
Research Site
St Louis, Missouri, 63110
- Recruiting
Research Site
Tampa, Florida, 33612
About this study
Official title: A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
Read the 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.
- Conditions
- Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC (Non-small Cell Lung Cancer), CRC (Colorectal Cancer), Advanced Solid Tumors
- Being tested
- ALTA3263, cetuximab, mFOLFOX6, Pembrolizumab, Pemetrexed + Cisplatin /Carboplatin
- 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
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Neoplasms by Site, Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTA3263Drug
Oral ALTA3263 tablets will be administered at a protocol-defined dose
cetuximabDrug
Cetuximab injection for IV use will be administered at a protocol-defined dose
mFOLFOX6Drug
modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose
PembrolizumabDrug
Pembrolizumab injection for IV use will be administered at a protocol-defined dose
Pemetrexed + Cisplatin /CarboplatinDrug
Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose
mFOLFIRINOXDrug
modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose
GnPDrug
gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose
MidazolamDrug
Oral midazolam will be administered at a protocol-defined dose
| Study group | Role | What they receive |
|---|---|---|
| ALTA3263 monotherapy | Experimental | ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment Receives: Drug: ALTA3263 |
| ALTA3263 in combination with cetuximab | Experimental | ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment Receives: Drug: ALTA3263; Drug: cetuximab |
| ALTA3263 in combination with mFOLFOX6 plus cetuximab | Experimental | 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 Receives: Drug: ALTA3263; Drug: cetuximab; Drug: mFOLFOX6 |
| ALTA3263 in combination with pembrolizumab | Experimental | ALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment Receives: Drug: ALTA3263; Drug: Pembrolizumab |
| ALTA3263 in combination with pembrolizumab plus chemotherapy | Experimental | ALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment Receives: Drug: ALTA3263; Drug: Pembrolizumab; Drug: Pemetrexed + Cisplatin /Carboplatin |
| ALTA3263 in combination with mFOLFIRINOX | Experimental | 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 Receives: Drug: ALTA3263; Drug: mFOLFIRINOX |
| ALTA3263 in combination with mFOLFIRINOX plus cetuximab | Experimental | 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 Receives: Drug: ALTA3263; Drug: cetuximab; Drug: mFOLFIRINOX |
| ALTA3263 in combination with GnP | Experimental | ALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment Receives: Drug: ALTA3263; Drug: GnP |
| ALTA3263 in combination with GnP plus cetuximab | Experimental | ALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment Receives: Drug: ALTA3263; Drug: cetuximab; Drug: GnP |
| ALTA3263 Midazolam DDI Substudy | Experimental | ALTA3263 and midazolam will be administered at a protocol defined schedule Receives: Drug: ALTA3263; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants that experience treatment-emergent adverse events (TEAEs).
Measured: Up to 39 months
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs).
Measured: 21 days
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Cmax
Measured: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax
Measured: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
AUCt
Measured: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)
t1/2
Measured: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose
Objective Response Rate (ORR)
Assess per RECIST 1.1
Measured: Up to 39 months
Duration of Response (DOR)
Assess per RECIST 1.1
Measured: Up to 39 months
Progression-Free Survival (PFS)
Assess per RECIST 1.1
Measured: Up to 39 months
Overall Survival (OS)
Assess per RECIST 1.1
Measured: Up to 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start5 Mar 2025
- Primary completionMay 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alterome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Medical Director, Study director, Alterome Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835569
- Sponsor's protocol ID
- 3263-001
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
- ClinicalTrials.gov ID
- NCT06835569
- Acronym / sponsor ID
- 3263-001
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Alterome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| ALTA3263 monotherapy | Experimental | Drug: ALTA3263ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment |
| ALTA3263 in combination with cetuximab | Experimental | Drug: ALTA3263, Drug: cetuximabALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment |
| ALTA3263 in combination with mFOLFOX6 plus cetuximab | Experimental | Drug: ALTA3263, Drug: cetuximab, Drug: mFOLFOX6ALTA3263 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 |
| ALTA3263 in combination with pembrolizumab | Experimental | Drug: ALTA3263, Drug: PembrolizumabALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment |
| ALTA3263 in combination with pembrolizumab plus chemotherapy | Experimental | Drug: ALTA3263, Drug: Pembrolizumab, Drug: Pemetrexed + Cisplatin /CarboplatinALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment |
| ALTA3263 in combination with mFOLFIRINOX | Experimental | Drug: ALTA3263, Drug: mFOLFIRINOXALTA3263 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 |
| ALTA3263 in combination with mFOLFIRINOX plus cetuximab | Experimental | Drug: ALTA3263, Drug: cetuximab, Drug: mFOLFIRINOXALTA3263 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 |
| ALTA3263 in combination with GnP | Experimental | Drug: ALTA3263, Drug: GnPALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment |
| ALTA3263 in combination with GnP plus cetuximab | Experimental | Drug: ALTA3263, Drug: cetuximab, Drug: GnPALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment |
| ALTA3263 Midazolam DDI Substudy | Experimental | Drug: ALTA3263, Drug: MidazolamALTA3263 and midazolam will be administered at a protocol defined schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALTA3263Oral ALTA3263 tablets will be administered at a protocol-defined dose | Drug | ALTA3263 Midazolam DDI Substudy, ALTA3263 in combination with GnP, ALTA3263 in combination with GnP plus cetuximab, ALTA3263 in combination with cetuximab, ALTA3263 in combination with mFOLFIRINOX, ALTA3263 in combination with mFOLFIRINOX plus cetuximab, ALTA3263 in combination with mFOLFOX6 plus cetuximab, ALTA3263 in combination with pembrolizumab, ALTA3263 in combination with pembrolizumab plus chemotherapy, ALTA3263 monotherapy |
| cetuximabCetuximab injection for IV use will be administered at a protocol-defined dose | Drug | ALTA3263 in combination with GnP plus cetuximab, ALTA3263 in combination with cetuximab, ALTA3263 in combination with mFOLFIRINOX plus cetuximab, ALTA3263 in combination with mFOLFOX6 plus cetuximab |
| mFOLFOX6modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose | Drug | ALTA3263 in combination with mFOLFOX6 plus cetuximab |
| PembrolizumabPembrolizumab injection for IV use will be administered at a protocol-defined dose | Drug | ALTA3263 in combination with pembrolizumab, ALTA3263 in combination with pembrolizumab plus chemotherapy |
| Pemetrexed + Cisplatin /CarboplatinPemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose | Drug | ALTA3263 in combination with pembrolizumab plus chemotherapy |
| mFOLFIRINOXmodified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose | Drug | ALTA3263 in combination with mFOLFIRINOX, ALTA3263 in combination with mFOLFIRINOX plus cetuximab |
| GnPgemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose | Drug | ALTA3263 in combination with GnP, ALTA3263 in combination with GnP plus cetuximab |
| MidazolamOral midazolam will be administered at a protocol-defined dose | Drug | ALTA3263 Midazolam DDI Substudy |
Primary outcome
Adverse Events
Time frame: Up to 39 months
Number of participants that experience treatment-emergent adverse events (TEAEs).
Dose Limiting Toxicities
Time frame: 21 days
Number of participants with Dose Limiting Toxicities (DLTs).
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)
Time frame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose
Objective Response Rate (ORR)
Time frame: Up to 39 months
Duration of Response (DOR)
Time frame: Up to 39 months
Progression-Free Survival (PFS)
Time frame: Up to 39 months
Overall Survival (OS)
Time frame: Up to 39 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Medical Director study director
Alterome Therapeutics
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALTA3263, cetuximab and mFOLFOX6 in people with Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by Alterome Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alterome Clinical Trial Contact Center (619-768-8189, clinical.trials@alterome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to 39 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.