SNV1521 in Participants with Advanced Solid Tumors

NCT ID: NCT06220864

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-23

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Group Type EXPERIMENTAL

SNV1521

Intervention Type DRUG

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

Dose Expansion

Group Type EXPERIMENTAL

SNV1521

Intervention Type DRUG

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

Combination Dose Escalation

Group Type EXPERIMENTAL

SNV1521

Intervention Type DRUG

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

Trastuzumab Deruxtecan

Intervention Type DRUG

Trastuzumab Deruxtecan is given as an infusion based upon prescribing information.

Dose Expansion for Metastatic Castration Resistant Prostate Cancer

Group Type EXPERIMENTAL

SNV1521

Intervention Type DRUG

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

Dose Expansion for Pancreatic Ductal Adenocarcinoma

Group Type EXPERIMENTAL

SNV1521

Intervention Type DRUG

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

Dose Expansion for Solid Tumors with Brain Metastases

Group Type EXPERIMENTAL

SNV1521

Intervention Type DRUG

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

Interventions

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SNV1521

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

Intervention Type DRUG

Trastuzumab Deruxtecan

Trastuzumab Deruxtecan is given as an infusion based upon prescribing information.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synnovation Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

START Center for Cancer Care

West Valley City, Utah, United States

Site Status RECRUITING

Scientia Clinical Research

Randwick, New South Wales, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Linear Clinical Research

Crawley, Western Australia, Australia

Site Status RECRUITING

Countries

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United States Australia

Central Contacts

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Robert Casper

Role: CONTACT

443-764-9527

Other Identifiers

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SNV1521-101

Identifier Type: -

Identifier Source: org_study_id

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