Pancreatic AdenocarcinomaPhase 1NCT06217666
Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
A Phase 1 study testing PCX-12 in people with Pancreatic Adenocarcinoma, run by Haoming (Carl) Qiu at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- PCX-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Dec 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
- Patient with pathologically proven diagnosis of adenocarcinoma of the pancreas
- After chemotherapy, tumor is determined to be either locally advanced or unresectable by hepatobiliary surgeon; or tumor is considered potentially resectable but subject does not proceed with surgical resection for any reason
- Have completed first line chemotherapy without progression or non-regional metastases
- Tumor is radiographically evident on CT scan after chemotherapy
- Tumor is anatomically amenable to SBRT, e.g. does not directly invade the stomach or bowel
- Tumor is amenable to intra-tumor injection under endoscopic ultrasound guidance
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- ECOG performance status 0-2
- Patients with childbearing potential must demonstrate a negative urine or serum pregnancy test
- Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year
- Patient must be able to understand and willingly sign study specific informed consent prior to study entry
- Anticipated life expectancy ≥ 12 weeks
- Patients aged at least 18 years of age
Who cannot join
- Progression of disease or metastatic disease after first line systemic therapy
- Prior radiation treatment or surgical resection of any pancreatic malignancy
- Inability to tolerate SBRT, Endoscopic ultrasound or IL-12 Injection procedure
- Lack of radiographically evident disease after first line chemotherapy
- Severe, active comorbidity that shortens the patient's life expectancy to less than 12 weeks
- History of past malignancy
- Patient who is pregnant and/or breastfeeding
- Inability to comply with other required protocol procedures including required biopsies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Rochester
Rochester, New York, 14642
Haoming Qiu
About this study
Official title: A Phase 1, Prospective, Standard Dose Escalation Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.
Read the detailed description
Single center, open label, escalating dosage of PCX12 with standard of care practice for subjects who are diagnosed with adenocarcinoma of the head of the pancreas. Subjects with undergo standard of care radiation therapy and then start on PCX12 therapy starting at 200 ng/kg of PCX12 escalating to a potential maximum dosage of 800 ng/kg of PCX12 with adjacent tolerability and safety guidelines.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- PCX-12
- Keywords
- Pancreatic Adenocarcinoma, Pancreatic Cancer, PCX12, IL-12
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCX-12Drug
treatment combining radiation therapy with PCX12
| Study group | Role | What they receive |
|---|---|---|
| PCX-12 | Experimental | PCX-12 is an experimental immunotherapy drug that is injected into the pancreatic cancer one time in attempt to stimulate the patient's immune system to fight the cancer. Receives: Drug: PCX-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
The Primary objective of the safety lead in component is to report acute, attributable, gastrointestinal toxicity
Measured: 3 years
Maximum tolerable dose [Safety and Tolerability]
Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose
Measured: 3 years
Secondary outcomes (2)
Rate of radiographic response
This study will assess radiographic response following SBRT and PCX12 utilizing RECIST 1.1 criteria
Measured: 2 months
Change in biomarkers of innate and adaptive immunity
A combination of flow/mass cytometry will be employed to assess intratumoral immune cells before and after treatment. Specifically, cells of the adaptive immune system, namely B and T cells (both CD4+ and CD8+), along with innate cells including monocytes, macrophages, neutrophils, and natural killer cells will be investigated and percent of total CD45+ cells along with absolute cell number will be tabulated. Additionally, markers of activation (IFNg, TNF, etc.) along with suppression (PD1, PD-L1, LAG3, etc.) will be included in the panel of analysis.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haoming (Carl) Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haoming (Carl) Qiu, University of Rochester
- Investigators
- Haoming Qiu, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217666
- Sponsor's protocol ID
- URGIP24061
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Prospective, Standard Dose Escalation Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
- ClinicalTrials.gov ID
- NCT06217666
- Acronym / sponsor ID
- URGIP24061
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic Adenocarcinoma, Pancreatic Cancer, PCX12, IL-12
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Haoming (Carl) QiuUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 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.
The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.
Detailed description
Single center, open label, escalating dosage of PCX12 with standard of care practice for subjects who are diagnosed with adenocarcinoma of the head of the pancreas. Subjects with undergo standard of care radiation therapy and then start on PCX12 therapy starting at 200 ng/kg of PCX12 escalating to a potential maximum dosage of 800 ng/kg of PCX12 with adjacent tolerability and safety guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCX-12 | Experimental | Drug: PCX-12PCX-12 is an experimental immunotherapy drug that is injected into the pancreatic cancer one time in attempt to stimulate the patient's immune system to fight the cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with pathologically proven diagnosis of adenocarcinoma of the pancreas
- After chemotherapy, tumor is determined to be either locally advanced or unresectable by hepatobiliary surgeon; or tumor is considered potentially resectable but subject does not proceed with surgical resection for any reason
- Have completed first line chemotherapy without progression or non-regional metastases
- Tumor is radiographically evident on CT scan after chemotherapy
- Tumor is anatomically amenable to SBRT, e.g. does not directly invade the stomach or bowel
Key exclusion criteria (8 listed)
- Progression of disease or metastatic disease after first line systemic therapy
- Prior radiation treatment or surgical resection of any pancreatic malignancy
- Inability to tolerate SBRT, Endoscopic ultrasound or IL-12 Injection procedure
- Lack of radiographically evident disease after first line chemotherapy
- Severe, active comorbidity that shortens the patient's life expectancy to less than 12 weeks
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 |
|---|---|---|
| PCX-12treatment combining radiation therapy with PCX12 | Drug | PCX-12 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: 3 years
The Primary objective of the safety lead in component is to report acute, attributable, gastrointestinal toxicity
Maximum tolerable dose [Safety and Tolerability]
Time frame: 3 years
Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose
2 secondary outcomes
Rate of radiographic response
Time frame: 2 months
Change in biomarkers of innate and adaptive immunity
Time frame: baseline and 4 weeks
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 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Haoming Qiu principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PCX-12 in people with Pancreatic Adenocarcinoma, run by Haoming (Carl) Qiu at 1 site 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 12 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Haoming Qiu (585-275-5863, WCICTOResearch@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: 3 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 5 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.