Health TrialsbyHealthPanel

SNV1521 in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSynnovation Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Advanced or metastatic solid tumor malignancy

Evaluable or Measurable disease (RECIST 1.1 Criteria).

ECOG Performance Status 0 or 1.

Life expectancy > 3 months

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SNV1521

    Drug

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

  • DB-1310

    Drug

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

  • Abiraterone

    Drug

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

  • Darolutamide

    Drug

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

Treatment groups

400 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group C: Combination Dose EscalationExperimental treatment 2 interventions
Group D: Dose Expansion for Metastatic Castration Resistant Prostate CancerExperimental treatment 1 intervention
Group E: Dose Expansion for Pancreatic Ductal AdenocarcinomaExperimental treatment 1 intervention
Group F: Dose Expansion for Solid Tumors with Brain MetastasesExperimental treatment 1 intervention
Group G: Dose Expansion for Breast CancerExperimental treatment 1 intervention
Group H: Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal CancerExperimental treatment 1 intervention
Group I: Combination 1 Dose Expansion for mCRPC or mCSPCExperimental treatment 1 intervention
Group J: Combination 2 Dose Expansion for mCRPC or mCSPCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of SNV1521

Treatment emergent adverse events (TEAEs)

Time frame
From first dose through last dose (up to 13 months)
2

Tolerability of SNV1521

Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)

Time frame
DLTs: From first dose through completion of first cycle (28 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Synnovation Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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