A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Vividion Therapeutics, Inc.
Study ID
NCT05954312
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VVD-130037 — DRUG
    Oral tablets
  • Docetaxel — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion
  • Pembrolizumab — DRUG
    IV infusion

Study Details

A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.

Key Dates

Start date
Jul 28, 2023
Status verified
May 2026
Primary completion
Aug 31, 2030
Completion
Feb 28, 2031

Study Design

Enrollment
290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Dose Escalation): VVD-130037 Single Agent
    Participants will receive ascending doses of VVD-130037, orally, once or twice daily in 21-day treatment cycles during Part 1.
  • Experimental: Part 1 (Dose Escalation): VVD-130037 and Docetaxel Combination Therapy
    Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with docetaxel intravenous (IV) infusion administered once every 3 weeks in 21-day treatment cycles during Part 1.
  • Experimental: Part 1 (Dose Escalation): VVD-130037 and Paclitaxel Combination Therapy
    Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 1.
  • Experimental: Part 2 (Dose Expansion): VVD-130037 Single Agent
    Participants will receive VVD-130037 at the recommended dose for expansion (RDE), orally, once or twice daily in 21-day treatment cycles during Part 2.
  • Experimental: Part 2 (Dose Expansion): VVD-130037 and Docetaxel Combination Therapy
    Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with docetaxel IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.
  • Experimental: Part 2 (Dose Expansion): VVD-130037 and Paclitaxel Combination Therapy
    Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 2.
  • Experimental: Experimental: Part 2 (Dose Expansion): VVD-130037 and Pembrolizumab Combination Therapy
    Participants will first be evaluated in a safety-run in cohort to determine the RDE(s). Participants will then receive VVD-130037 at the RDE, orally, once or twice daily along with pembrolizumab IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2.

Primary Outcome Measure

Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period [ Time Frame: Part 1: Single Agent and Docetaxel/Pembrolizumab Combination Therapy: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] and Part 1: Paclitaxel Combination Therapy: From Day 1 to Day 28 of Cycle 1 [cycle length=28 days] ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Florida Cancer SpecialistsSarasotaFlorida34232-
Moffitt Cancer CenterTampaFlorida33612-
Mayo Clinic RochesterRochesterMinnesota55905-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MDACCHoustonTexas77030-
NEXT DallasIrvingTexas75039-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic Jacksonville· Jacksonville, FLFlorida Cancer Specialists· Sarasota, FLMoffitt Cancer Center· Tampa, FLMayo Clinic Rochester· Rochester, MNSarah Cannon Research Institute· Nashville, TNMDACC· Houston, TX

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