A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Vividion Therapeutics, Inc.
Study ID
NCT06004245
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • VVD-133214 — DRUG
    VVD-133214 will be administered orally and once daily (QD) in 3-week cycles.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered by intravenous (IV) infusion at a fixed dose of 200 mg on Day 1 of each 21-day cycle.
  • Bevacizumab — DRUG
    Bevacizumab will be administered by intravenous (IV) infusion at a fixed dose of 7.5 mg/kg on Day 1 of each 21-day cycle.

Study Details

This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.

Key Dates

Start date
Jan 25, 2024
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
280 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VVD-133214 Dose Escalation
  • Experimental: VVD-133214 Monotherapy Expansion
  • Experimental: VVD-133214 + Pembrolizumab Expansion
  • Experimental: VVD-133214 + Bevacizumab Expansion

Primary Outcome Measure

Incidence of Adverse Events, with Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) [ Time Frame: From first dose of study drug(s) until 30 days after the final dose of VVD-133214 or 90 days after last dose of bevacizumab or pembrolizumab ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
City of Hope at Irvine LennarIrvineCalifornia91355-
Emory University School of MedicineAtlantaGeorgia30322
Vividion Clinical Trial Call Center
[email protected]
+1 8583459752
Norton Cancer Institute - MDCLouisvilleKentucky40202-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Vividion Clinical Trial Call Center
[email protected]
+1 8583459752
Duke UniversityDurhamNorth Carolina27705-
Oklahoma University Health Sciences CenterOklahoma CityOklahoma73170-
SCRI Oncology PartnersNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope Cancer Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CAEmory University School of Medicine· Atlanta, GANorton Cancer Institute - MDC· Louisville, KYRutgers Cancer Institute of New Jersey· New Brunswick, NJDuke University· Durham, NC

Related Studies