Advanced Solid TumorPhase 1NCT06220864
SNV1521 in Participants With Advanced Solid Tumors
A Phase 1 study testing SNV1521, DB-1310 and Abiraterone in people with Advanced Solid Tumor, run by ParVation Therapeutics, Inc. at 25 sites in 7 countries.
Trial summary
This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SNV1521, DB-1310 and Abiraterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 23 Feb 2024to Dec 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
- Advanced or metastatic solid tumor malignancy
- Evaluable or Measurable disease (RECIST 1.1 Criteria).
- ECOG Performance Status 0 or 1.
- Life expectancy > 3 months
Who cannot join
- History of other malignancy within the past 2 years
- Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
- Significant cardiovascular disease within 6 months
- Significant gastrointestinal disease
- HIV infection with a CD4+ T-cell count < 200 cells/μL and/or a detectable viral load
- Liver dysfunction
Trial locations and contacts
25 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 7 countries
United States5 sites, 5 recruiting
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06511
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144
- Recruiting
START Center for Cancer Care
West Valley City, Utah, 84119
Australia5 sites, 5 recruiting
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Linear Clinical Research
Crawley, Western Australia, 6009
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Belgium4 sites, 4 recruiting
- Recruiting
The Institut Jules Bordet
Brussels, 1070
Nuria Kotecki, +32 2 541 31 11, nuria.kotecki@hubruxelles.be
- Recruiting
University Center for Clinical Research Antwerp (UNICCRA)
Edegem, 2650
Hans Prenen, 32 3 821 46 67, research.oncologie@uza.be
- Recruiting
AZ Maria Middelares
Ghent, 9000
Christof Vulsteke, +32 9 2469522, christof.vulsteke@uantwerpen.be
- Recruiting
AZ Groeninge
Kortrijk, 8500
Karl Lesage, urologie@azgroeninge.be, urologie@azgroeninge.be
Spain4 sites, 4 recruiting
- Recruiting
NEXT Oncology - Barcelona
Barcelona, 08023
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
- Recruiting
The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro
Madrid, 28050
- Recruiting
NEXT Oncology - Hospital Quironsalud Madrid
Madrid, 28223
France3 sites, 3 recruiting
- Recruiting
Institut Bergonie
Bordeaux, 33076
- Recruiting
UNICANCER - Centre Leon-Berard (CLB)
Lyon, 69008
- Recruiting
Gustave Roussy
Villejuif, 94805
Canada2 sites, 2 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
- Recruiting
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Italy2 sites, 2 recruiting
- Recruiting
Istituto Clinico Humanitas
Milan, 20089
- Recruiting
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Milan, 20141
About this study
Official title: A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors
This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.
- Conditions
- Advanced Solid Tumor
- Being tested
- SNV1521, DB-1310, Abiraterone, Darolutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNV1521Drug
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
DB-1310Drug
DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
AbirateroneDrug
Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
DarolutamideDrug
Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: SNV1521 |
| Monotherapy Dose Expansion | Experimental | Not described Receives: Drug: SNV1521 |
| Combination Dose Escalation | Experimental | Not described Receives: Drug: SNV1521; Drug: DB-1310 |
| Dose Expansion for Metastatic Castration Resistant Prostate Cancer | Experimental | Not described Receives: Drug: SNV1521 |
| Dose Expansion for Pancreatic Ductal Adenocarcinoma | Experimental | Not described Receives: Drug: SNV1521 |
| Dose Expansion for Solid Tumors with Brain Metastases | Experimental | Not described Receives: Drug: SNV1521 |
| Dose Expansion for Breast Cancer | Experimental | Not described Receives: Drug: SNV1521 |
| Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer | Experimental | Not described Receives: Drug: SNV1521 |
| Combination 1 Dose Expansion for mCRPC or mCSPC | Experimental | Not described Receives: Drug: Abiraterone |
| Combination 2 Dose Expansion for mCRPC or mCSPC | Experimental | Not described Receives: Drug: Darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of SNV1521
Treatment emergent adverse events (TEAEs)
Measured: From first dose through last dose (up to 13 months)
Tolerability of SNV1521
Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)
Measured: DLTs: From first dose through completion of first cycle (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start23 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ParVation Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220864
- Sponsor's protocol ID
- SNV1521-101
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 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 Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06220864
- Acronym / sponsor ID
- SNV1521-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ParVation Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 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.
This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: SNV1521 |
| Monotherapy Dose Expansion | Experimental | Drug: SNV1521 |
| Combination Dose Escalation | Experimental | Drug: SNV1521, Drug: DB-1310 |
| Dose Expansion for Metastatic Castration Resistant Prostate Cancer | Experimental | Drug: SNV1521 |
| Dose Expansion for Pancreatic Ductal Adenocarcinoma | Experimental | Drug: SNV1521 |
| Dose Expansion for Solid Tumors with Brain Metastases | Experimental | Drug: SNV1521 |
| Dose Expansion for Breast Cancer | Experimental | Drug: SNV1521 |
| Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer | Experimental | Drug: SNV1521 |
| Combination 1 Dose Expansion for mCRPC or mCSPC | Experimental | Drug: Abiraterone |
| Combination 2 Dose Expansion for mCRPC or mCSPC | Experimental | Drug: Darolutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced or metastatic solid tumor malignancy
- Evaluable or Measurable disease (RECIST 1.1 Criteria).
- ECOG Performance Status 0 or 1.
- Life expectancy > 3 months
Key exclusion criteria (6 listed)
- History of other malignancy within the past 2 years
- Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
- Significant cardiovascular disease within 6 months
- Significant gastrointestinal disease
- HIV infection with a CD4+ T-cell count < 200 cells/μL and/or a detectable viral load
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 |
|---|---|---|
| SNV1521SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm. | Drug | Combination Dose Escalation, Dose Expansion for Breast Cancer, Dose Expansion for Metastatic Castration Resistant Prostate Cancer, Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer, Dose Expansion for Pancreatic Ductal Adenocarcinoma, Dose Expansion for Solid Tumors with Brain Metastases, Monotherapy Dose Escalation, Monotherapy Dose Expansion |
| DB-1310DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm. | Drug | Combination Dose Escalation |
| AbirateroneAbiraterone is taken orally. Dose and frequency are per approved prescribing instructions. | Drug | Combination 1 Dose Expansion for mCRPC or mCSPC |
| DarolutamideDarolutamide is taken orally. Dose and frequency are per approved prescribing instructions. | Drug | Combination 2 Dose Expansion for mCRPC or mCSPC |
Primary outcome
Safety of SNV1521
Time frame: From first dose through last dose (up to 13 months)
Treatment emergent adverse events (TEAEs)
Tolerability of SNV1521
Time frame: DLTs: From first dose through completion of first cycle (28 days)
Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)
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 25 Jun 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.
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNV1521, DB-1310 and Abiraterone in people with Advanced Solid Tumor, run by ParVation Therapeutics, Inc. at 25 sites in 7 countries.
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 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia, Belgium, Spain, France and 2 more countries. 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 Robert Casper (443-764-9527, rcasper@synnovationtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of SNV1521 (time frame: From first dose through last dose (up to 13 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 25 Jun 2026.