Solid TumorsPhase 1NCT06227377
QTX3034 in Patients With KRAS G12D Mutation
A Phase 1 study testing QTX3034 and Cetuximab in people with Solid Tumors, run by Quanta Therapeutics at 14 sites in United States.
Trial summary
Phase 1 study to determine the safety and tolerability of QTX3034 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
- Solid Tumors
- What is being tested?
- QTX3034 and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 14 sitesUnited States
- Study dates
- 5 Feb 2024to 1 Apr 2027
- 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 G12D mutation 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 1 prior systemic therapy
- Evaluable or Measurable disease per RECIST 1.1.
- Parts 2 and 3: Measurable disease per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ function
Who cannot join
- Prior treatment with a KRAS inhibitor
- Active brain metastases or carcinomatous meningitis
- History of other malignancy within 2 years
- Significant cardiovascular disease
- Disease or disorder that may pose a risk to patient's safety
- Other protocol-defined 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
Sarah Cannon Research Institute (SCRI)
Denver, Colorado, 80218
Front Desk, 720-754-2610, cann.ddudenvergeneral@sarahcannon.com
- Recruiting
Duke University
Durham, North Carolina, 27710
Sabina Wlazlo, 919-668-1861, sabina.wlazlo@duke.edu
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Blake Patterson, 703-783-4505, bpatterson@nextoncology.com
- Recruiting
MD Anderson
Houston, Texas, 77030
Ly Nguyen, 713-563-1930, LMNguyen1@mdanderson.org
- Recruiting
UCLA Hematology/Oncology
Los Angeles, California, 90095
Jenna Davis, 310-633-8400 ext. 16128, JLdavis@mednet.ucla.edu
- Recruiting
SCRI- Nashville
Nashville, Tennessee, 37203
askSarah, 844-482-4812, SCRI.Webmaster@scri.com
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06511
Ingrid Palma, 203-833-1034, ingrid.palma@yale.edu
- Recruiting
NYU Langone Health
New York, New York, 10016
DL_Phase1Screening, DL_Phase1Screening@nyulangone.org
- Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Michelle Johnson, 405-271-8777 ext. 42596, michelle-a-johnson@ouhsc.edu
Lana Seibert, lalana-seibert@ouhsc.edu
- Recruiting
University of Utah, Huntsman Cancer Center
Salt Lake City, Utah, 84112
Susan Sharry, 801-585-3453, susan.sharry@hci.utah.edu
- Recruiting
START San Antonio, LLC
San Antonio, Texas, 78229
Isabel Jimenez, RN, MSN, 210-593-5265, isabel.jimenez@startresearch.com
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Carly Taylor, 941-377-9993, Ctaylor@flcancer.com
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Melyrene Pomales, 813-745-4035, melyrene.pomales@moffitt.org
Samuel Gobran, 813-745-4610, samuel.gobran@moffitt.org
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Gunnar Lauer, 718-405-8124, glauer@montefiore.org
About this study
Official title: A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
- Conditions
- Solid Tumors
- Being tested
- QTX3034, Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QTX3034Drug
QTX3034 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: QTX3034 monotherapy dose-escalation | Experimental | QTX3034 will be administered at protocol defined dose based on cohort assignment Receives: Drug: QTX3034 |
| Part 1b: QTX3034 combination with cetuximab dose-escalation | Experimental | QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment Receives: Drug: QTX3034; Combination Product: Cetuximab |
| Part 2: QTX3034 monotherapy dose-expansion | Experimental | QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment Receives: Drug: QTX3034 |
| Part 3: QTX3034 combination with cetuximab dose-expansion | Experimental | QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment Receives: Drug: QTX3034; Combination Product: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined 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
Secondary outcomes (3)
QTX3034 pharmacokinetic parameters in plasma
Plasma concentration data for QTX3034 will be used to evaluate PK parameters such as maximum concentration (Cmax), minimum concentration (Cmin), time to attain Cmax (Tmax), area under the concentration-time curve (AUC), elimination half-life (t1⁄2).
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)
Duration of response (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 posted26 Jan 2024
- Study start5 Feb 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single group
- Masking
- None (open label)
- Enrolment
- 250 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
- NCT06227377
- Sponsor's protocol ID
- QTX3034-001
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2024
- Last updated
- 27 Apr 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
- ClinicalTrials.gov ID
- NCT06227377
- Acronym / sponsor ID
- QTX3034-001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Quanta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 26 Jan 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 and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1a: QTX3034 monotherapy dose-escalation | Experimental | Drug: QTX3034QTX3034 will be administered at protocol defined dose based on cohort assignment |
| Part 1b: QTX3034 combination with cetuximab dose-escalation | Experimental | Drug: QTX3034, Combination Product: CetuximabQTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
| Part 2: QTX3034 monotherapy dose-expansion | Experimental | Drug: QTX3034QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
| Part 3: QTX3034 combination with cetuximab dose-expansion | Experimental | Drug: QTX3034, Combination Product: CetuximabQTX3034 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 (6 listed)
- Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation 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 1 prior systemic therapy
- Evaluable or Measurable disease per RECIST 1.1.
- Parts 2 and 3: Measurable disease per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (6 listed)
- Prior treatment with a KRAS inhibitor
- Active brain metastases or carcinomatous meningitis
- History of other malignancy within 2 years
- Significant cardiovascular disease
- Disease or disorder that may pose a risk to patient's safety
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 |
|---|---|---|
| QTX3034QTX3034 will be administered at protocol defined dose | Drug | Part 1a: QTX3034 monotherapy dose-escalation, Part 1b: QTX3034 combination with cetuximab dose-escalation, Part 2: QTX3034 monotherapy dose-expansion, Part 3: QTX3034 combination with cetuximab dose-expansion |
| CetuximabCetuximab will be administered at protocol defined dose. | Combination product | Part 1b: QTX3034 combination with cetuximab dose-escalation, Part 3: QTX3034 combination with cetuximab dose-expansion |
Primary outcome
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
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 2 years
Defined 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
3 secondary outcomes
QTX3034 pharmacokinetic parameters in plasma
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 27 Apr 2026.
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Solid Tumors
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.
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 QTX3034 and Cetuximab in people with Solid Tumors, run by Quanta Therapeutics 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 6 inclusion and 6 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 27 Apr 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 Quanta Therapeutics Clinical Trials (415-599-3892, clinicaltrials@quantatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: up to 21 days). 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 27 Apr 2026.