Advanced Solid TumorsPhase 1NCT06715124
QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
A Phase 1 study testing QTX3544 and Cetuximab in people with Advanced Solid Tumors, run by Quanta Therapeutics at 10 sites in United States.
Trial summary
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- QTX3544 and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Jan 2025to 2 Jan 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
- Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
- Part 1: Advanced solid tumors with at least one prior systemic therapy.
- Evaluable and measurable disease per RECIST v1.1.
- Part 2 and 3: Measurable disease per RECIST v1.1.
Who cannot join
- Active brain metastasis or carcinomatous meningitis
- Significant cardiovascular disease
- Active infection requiring intravenous (IV) antibiotics
- Prior treatment with a KRAS inhibitor
- Other protocol-defined Inclusion/Exclusion Criteria may apply
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Sarah Cannon Research Institute
Denver, Colorado, 80218
Duke Cancer Center
Durham, North Carolina, 27705
South Texas Accelerated Research Therapeutics, LLC Midwest
Grand Rapids, Michigan, 49546
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06511
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
South Texas Accelerated Research Therapeutics, LLC San Antonio
San Antonio, Texas, 78229
Florida Cancer Specialists & Research Institute
Sarasota, Florida, 34232
South Texas Accelerated Research Therapeutics Mountain Region, LLC
West Valley City, Utah, 84119
About this study
Official title: A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
- Conditions
- Advanced Solid Tumors
- Being tested
- QTX3544, Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QTX3544Drug
QTX3544 will be administered at protocol defined dose.
CetuximabCombination product
Cetuximab will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: QTX3544 monotherapy dose escalation | Experimental | QTX3544 will be administered at protocol defined dose based on cohort assignment Receives: Drug: QTX3544 |
| Part 1b: QTX3544 dose escalation in combination with cetuximab | Experimental | QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment Receives: Drug: QTX3544; Combination Product: Cetuximab |
| Part 2: QTX3544 monotherapy dose expansion | Experimental | QTX3544 will be administered at protocol defined dose based on cohort assignment Receives: Drug: QTX3544 |
| Part 3: QTX3544 dose expansion in combination with cetuximab | Experimental | QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment Receives: Drug: QTX3544; Combination Product: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.
Measured: up to 2 years
Number of participants with Dose Limiting Toxicities (DLTs)
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.
Measured: up to 21 days
Secondary outcomes (4)
Area under the plasma concentration-time curve (AUC) of QTX3544
Plasma concentration data for QTX3544 will be used to evaluate the area under the concentration-time curve (AUC) of QTX3544.
Measured: up to 2 years
Peak plasma concentration of QTX3544 (Cmax)
Plasma concentration data for QTX3544 will be used to evaluate peak plasma concentration (Cmax) of QTX3544.
Measured: up to 2 years
Objective response rate (ORR)
The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.
Measured: up to 2 years
Duration of response (DoR)
DoR is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start14 Jan 2025
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715124
- Sponsor's protocol ID
- QTX3544-201
- Status last verified
- Jun 2025
- First submitted
- 26 Nov 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
- ClinicalTrials.gov ID
- NCT06715124
- Acronym / sponsor ID
- QTX3544-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Quanta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 4 Dec 2024 (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.
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1a: QTX3544 monotherapy dose escalation | Experimental | Drug: QTX3544QTX3544 will be administered at protocol defined dose based on cohort assignment |
| Part 1b: QTX3544 dose escalation in combination with cetuximab | Experimental | Drug: QTX3544, Combination Product: CetuximabQTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
| Part 2: QTX3544 monotherapy dose expansion | Experimental | Drug: QTX3544QTX3544 will be administered at protocol defined dose based on cohort assignment |
| Part 3: QTX3544 dose expansion in combination with cetuximab | Experimental | Drug: QTX3544, Combination Product: CetuximabQTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
- Part 1: Advanced solid tumors with at least one prior systemic therapy.
- Evaluable and measurable disease per RECIST v1.1.
- Part 2 and 3: Measurable disease per RECIST v1.1.
Key exclusion criteria (5 listed)
- Active brain metastasis or carcinomatous meningitis
- Significant cardiovascular disease
- Active infection requiring intravenous (IV) antibiotics
- Prior treatment with a KRAS inhibitor
- Other protocol-defined 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 |
|---|---|---|
| QTX3544QTX3544 will be administered at protocol defined dose. | Drug | Part 1a: QTX3544 monotherapy dose escalation, Part 1b: QTX3544 dose escalation in combination with cetuximab, Part 2: QTX3544 monotherapy dose expansion, Part 3: QTX3544 dose expansion in combination with cetuximab |
| CetuximabCetuximab will be administered at protocol defined dose. | Combination product | Part 1b: QTX3544 dose escalation in combination with cetuximab, Part 3: QTX3544 dose expansion in combination with cetuximab |
Primary outcome
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 2 years
Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: up to 21 days
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.
4 secondary outcomes
Area under the plasma concentration-time curve (AUC) of QTX3544
Time frame: up to 2 years
Peak plasma concentration of QTX3544 (Cmax)
Time frame: up to 2 years
Objective response rate (ORR)
Time frame: up to 2 years
Duration of response (DoR)
Time frame: up to 2 years
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 2 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 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 QTX3544 and Cetuximab in people with Advanced Solid Tumors, run by Quanta Therapeutics at 10 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment-emergent Adverse Events (TEAEs) (time frame: up to 2 years). 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 2 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.