Pancreatic CancerPhase 1NCT07756281
First in Human Study of SNV1521 With a RAS Inhibitor for People With Advanced Pancreatic Cancer
A Phase 1 study testing SNV1521 and daraxonrasib in people with Pancreatic Cancer and Pancreatic Acinar Carcinoma, run by ParVation Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is a Phase 1 clinical trial testing an oral investigational drug called SNV1521 together with a RAS-targeted cancer medicine in people with pancreatic cancer that cannot be removed by surgery or has spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Acinar Carcinoma
- What is being tested?
- SNV1521 and daraxonrasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jun 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
- Adults (18 years and older).
- Diagnosis of pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body.
- Cancer confirmed by tissue or cell examination (histology or cytology).
- At least one measurable tumor on scans.
- Good enough general health and organ function to receive study treatment, as judged by the study doctor.
- Able to swallow oral medicines.
- Willing to follow study visit schedule and contraception requirements.
Who cannot join
- Serious heart, lung, liver, or other medical problems that would make study treatment unsafe.
- Active, uncontrolled infections.
- Other active cancers that could interfere with study assessments (except certain early-stage cancers that have been treated).
- Prior treatments or medicines that are not allowed by the protocol (for example, some strong drug interactions).
- Known brain or nervous system involvement from the cancer that is not stable or controlled.
- Pregnant or breastfeeding, or unwilling to use required birth control during and after the study.
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, 1 recruiting
- Recruiting
MD Anderson
Houston, Texas, 77030
Tim Yap, 1-844-785-0306, option 1, PhysicianReferrals@MDAnderson.org
Tim Yap
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation and Expansion Study of SNV1521 in Combination With RAS Inhibition in Participants With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
This study is a Phase 1 clinical trial testing an oral investigational drug called SNV1521 together with a RAS-targeted cancer medicine in people with pancreatic cancer that cannot be removed by surgery or has spread. The main goals are to find doses of the drug combination that are safe and tolerable and to look for early signs that the treatment may help control the cancer. Participants will receive the study medicines in repeating cycles and will have regular blood tests, scans, and other exams to monitor side effects and how their cancer responds.
- Conditions
- Pancreatic Cancer, Pancreatic Acinar Carcinoma
- Being tested
- SNV1521, daraxonrasib
- Keywords
- daraxonrasib, PARP, pancreas, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNV1521Drug
Also called PARP inhibitor
SNV1521 is an oral investigational anticancer drug. In this study, SNV1521 is administered at different dose levels together with the RAS inhibitor daraxonrasib in adults with locally advanced unresectable or metastatic pancreatic cancer.
daraxonrasibDrug
Also called RAS inhibitor
Daraxonrasib is an oral targeted cancer medicine used in this study together with SNV1521. It is given once daily to help evaluate the safety and tolerability of the drug combination in people with advanced pancreatic cancer.
| Study group | Role | What they receive |
|---|---|---|
| Escalation | Experimental | Participants in this arm will take SNV1521 by mouth together with a RAS-targeted cancer medicine. The dose of SNV1521 will be increased in small steps to find a safe and tolerable dose of the combination in people with advanced pancreatic cancer. Receives: Drug: SNV1521; Drug: daraxonrasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities
Number, type, and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities in participants receiving SNV1521 plus daraxonrasib, used to identify doses suitable for further study, classified and graded according to CTCAE v6.0 and protocol-defined DLT criteria
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Maximum plasma concentration (Cmax) of SNV1521
Cmax of SNV1521 following oral dosing in combination with daraxonrasib, based on concentration-time data collected at protocol-specified PK time points
Measured: through study completion, an average of 1 year
Area under the plasma concentration-time curve (AUC) of SNV1521
AUC for SNV1521 following oral administration in combination with daraxonrasib, derived from concentration-time data at protocol-specified PK sampling time points
Measured: through study completion, an average of 1 year
Maximum plasma concentration (Cmax) of daraxonrasib
Cmax for daraxonrasib following oral administration in combination with SNV1521, derived from concentration-time data at protocol-specified PK sampling time points
Measured: through study completion, an average of 1 year
Area under the plasma concentration-time curve (AUC) of daraxonrasib
AUC for daraxonrasib following oral administration in combination with SNV1521, derived from concentration-time data at protocol-specified PK sampling time points.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ParVation Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Revolution Medicines, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756281
- Sponsor's protocol ID
- SNV1521-102
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2026
- Last updated
- 27 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation and Expansion Study of SNV1521 in Combination With RAS Inhibition in Participants With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07756281
- Acronym / sponsor ID
- SNV1521-102
- Conditions
- Pancreatic Cancer, Pancreatic Acinar Carcinoma
- Keywords
- daraxonrasib, PARP, pancreas, pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ParVation Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Revolution Medicines, Inc.
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 10 Aug 2026 (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.
This study is a Phase 1 clinical trial testing an oral investigational drug called SNV1521 together with a RAS-targeted cancer medicine in people with pancreatic cancer that cannot be removed by surgery or has spread. The main goals are to find doses of the drug combination that are safe and tolerable and to look for early signs that the treatment may help control the cancer. Participants will receive the study medicines in repeating cycles and will have regular blood tests, scans, and other exams to monitor side effects and how their cancer responds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escalation | Experimental | Drug: SNV1521, Drug: daraxonrasibParticipants in this arm will take SNV1521 by mouth together with a RAS-targeted cancer medicine. The dose of SNV1521 will be increased in small steps to find a safe and tolerable dose of the combination in people with advanced pancreatic cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (18 years and older).
- Diagnosis of pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body.
- Cancer confirmed by tissue or cell examination (histology or cytology).
- At least one measurable tumor on scans.
- Good enough general health and organ function to receive study treatment, as judged by the study doctor.
Key exclusion criteria (6 listed)
- Serious heart, lung, liver, or other medical problems that would make study treatment unsafe.
- Active, uncontrolled infections.
- Other active cancers that could interfere with study assessments (except certain early-stage cancers that have been treated).
- Prior treatments or medicines that are not allowed by the protocol (for example, some strong drug interactions).
- Known brain or nervous system involvement from the cancer that is not stable or controlled.
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 |
|---|---|---|
| SNV1521Also: PARP inhibitorSNV1521 is an oral investigational anticancer drug. In this study, SNV1521 is administered at different dose levels together with the RAS inhibitor daraxonrasib in adults with locally advanced unresectable or metastatic pancreatic cancer. | Drug | Escalation |
| daraxonrasibAlso: RAS inhibitorDaraxonrasib is an oral targeted cancer medicine used in this study together with SNV1521. It is given once daily to help evaluate the safety and tolerability of the drug combination in people with advanced pancreatic cancer. | Drug | Escalation |
Primary outcome
Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities
Time frame: through study completion, an average of 1 year
Number, type, and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities in participants receiving SNV1521 plus daraxonrasib, used to identify doses suitable for further study, classified and graded according to CTCAE v6.0 and protocol-defined DLT criteria
4 secondary outcomes
Maximum plasma concentration (Cmax) of SNV1521
Time frame: through study completion, an average of 1 year
Area under the plasma concentration-time curve (AUC) of SNV1521
Time frame: through study completion, an average of 1 year
Maximum plasma concentration (Cmax) of daraxonrasib
Time frame: through study completion, an average of 1 year
Area under the plasma concentration-time curve (AUC) of daraxonrasib
Time frame: through study completion, an average of 1 year
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 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.
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 SNV1521 and daraxonrasib in people with Pancreatic Cancer and Pancreatic Acinar Carcinoma, run by ParVation Therapeutics, Inc. 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 7 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 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 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 Kevin O'Hayer (919-451-6590, kohayer@synnovationtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (time frame: through study completion, an average of 1 year). 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 Oct 2026.