SNV1521 in Participants with Advanced Solid Tumors

Synnovation Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Trastuzumab Deruxtecan; Drug: SNV1521

Study type: Interventional

Funder types: Industry

Identifiers

NCT06220864

SNV1521-101

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 6 patient groups

Dose Escalation

Experimental group

Treatment:

Drug: SNV1521

Dose Expansion

Experimental group

Treatment:

Drug: SNV1521

Combination Dose Escalation

Experimental group

Treatment:

Drug: SNV1521

Drug: Trastuzumab Deruxtecan

Dose Expansion for Metastatic Castration Resistant Prostate Cancer

Experimental group

Treatment:

Drug: SNV1521

Dose Expansion for Pancreatic Ductal Adenocarcinoma

Experimental group

Treatment:

Drug: SNV1521

Dose Expansion for Solid Tumors with Brain Metastases

Experimental group

Treatment:

Drug: SNV1521