SNV1521 in Participants With Advanced Solid Tumors

A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06220864

Enrollment

400

Registered

2024-01-24

Start date

2024-02-23

Completion date

2027-12-01

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Brief 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. They are also investigating whether it can be combined with other cancer therapies.

Interventions

DRUGSNV1521

SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.

DRUGDB-1310

DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.

DRUGAbiraterone

Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.

DRUGDarolutamide

Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Advanced or metastatic solid tumor malignancy * Evaluable or Measurable disease (RECIST 1.1 Criteria). * ECOG Performance Status 0 or 1. * Life expectancy \> 3 months

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Safety of SNV1521	From first dose through last dose (up to 13 months)	Treatment emergent adverse events (TEAEs)
Tolerability of SNV1521	DLTs: From first dose through completion of first cycle (28 days)	Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)

Countries

Australia, Belgium, Canada, France, Italy, Spain, United States

Contacts

CONTACTRobert Casper

rcasper@synnovationtx.com443-764-9527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026