TerminatedPhase 1

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors

Stopped: The study has ended

United States132 participantsStarted 2024-01-05

Plain-language summary

A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
✓. Adequate organ and bone marrow function as defined in the protocol.
✓. For Combination Therapy Expansion:
✓. Measurable disease by RECIST version 1.1 as assessed by the Investigator.

Exclusion criteria

✕. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
✕. Prior allogeneic transplantation.
✕. History of cardiac diseases as defined in detail in the protocol.
✕. Clinically significant infection or any eye infection.
✕. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
✕. Combination Therapy Expansion:

What they're measuring

Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period

Timeframe: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]

Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs)

Timeframe: Up to approximately 4 years

Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: Up to approximately 4 years

Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations

Timeframe: Up to approximately 4 years

Trial details

NCT IDNCT06188208

SponsorVividion Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-21

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
✓. Adequate organ and bone marrow function as defined in the protocol.
✓. For Combination Therapy Expansion:
✓. Measurable disease by RECIST version 1.1 as assessed by the Investigator.

Exclusion criteria

✕. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
✕. Prior allogeneic transplantation.
✕. History of cardiac diseases as defined in detail in the protocol.
✕. Clinically significant infection or any eye infection.
✕. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).
✕. Combination Therapy Expansion:

What they're measuring

Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period

Timeframe: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]

Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs)

Timeframe: Up to approximately 4 years

Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: Up to approximately 4 years

Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations

Timeframe: Up to approximately 4 years