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

NCT06188208 | Terminated Phase 1 FDA Drug

• 2 other identifiers: VVD-130850-012023-508386-32-00
• Study Type: interventional
• Target: 132
• Locations: 3 countries
• Sites: 20

Brief 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.

Conditions

Advanced Solid Tumors; Advanced Hematologic Tumors

Keywords

VVD-130850; Phase I; First in Human; Cancer; small molecule; STAT3; NSCLC; STK11; LKB1; immunosuppression; Checkpoint inhibitor; PD-1

Outcome Measures

Primary Outcomes (4)

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

  Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  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)

  Up to approximately 4 years

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

  Up to approximately 4 years

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

  Up to approximately 4 years

Secondary Outcomes (9)

• Dose Escalation: QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters

  Up to approximately 4 years

• Dose Escalation: Recommended Dose for Expansion (RDE) of VVD-130850 as a Single Agent and in Combination with Pembrolizumab

  Up to approximately 4 years

• Dose Expansion: Overall Response Rate (ORR)

  Up to approximately 4 years

• Dose Expansion: Duration of Response (DoR)

  Up to approximately 4 years

• Dose Expansion: Progression-free Survival (PFS)

  Up to approximately 4 years

Study Arms (4)

Dose Escalation: VVD-130850 Single Agent

EXPERIMENTAL

Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.

Drug: VVD-130850

Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy

EXPERIMENTAL

Participants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase.

Drug: VVD-130850; Drug: Pembrolizumab

Dose Expansion: VVD-130850 Single Agent

EXPERIMENTAL

Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.

Drug: VVD-130850

Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy

EXPERIMENTAL

Participants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase.

Drug: VVD-130850; Drug: Pembrolizumab

Interventions

VVD-130850 DRUG

Oral tablets

Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy; Dose Escalation: VVD-130850 Single Agent; Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy; Dose Expansion: VVD-130850 Single Agent

Pembrolizumab DRUG

IV infusion

Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy; Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
• Must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (CPI). These therapies could have been given in the same line of therapy or different lines of therapy.
• Measurable disease by RECIST version 1.1 as assessed by the Investigator.

You may not qualify if:

• 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.
• Combination Therapy Expansion:
• Known hypersensitivity or contraindication to pembrolizumab or any of its components.
• Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes).

Sponsors & Collaborators

• Vividion Therapeutics, Inc.: lead

Study Sites (20)

California Research Institute

Los Angeles, California, 90027, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

NEXT Austin

Austin, Texas, 78758, United States

Location

MDACC

Houston, Texas, 77030, United States

Location

NEXT Dallas

Irving, Texas, 75039, United States

Location

NEXT San Antonio

San Antonio, Texas, 78299, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

Blacktown Hospital

Blacktown, New South Wales, Australia

Location

Orange Health Service

Orange, New South Wales, Australia

Location

Gold Coast University Hospital

Southport, Queensland, Australia

Location

Cancer Research South Australia

Adelaide, Australia

Location

ICON Cancer Research

South Brisbane, Australia

Location

START Barcelona Hospital HM Nou Delfos

Barcelona, Spain

Location

Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

NEXT Madrid

Madrid, Spain

Location

START Madrid CIOCC

Madrid, Spain

Location

Start Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 3, 2024
• Study Start: January 5, 2024
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); AU (5); ES (6)