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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVividion Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed metastatic or unresectable solid tumor.

Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the Investigator.

Have progressed on or after all prior standard-of-care therapies for metastatic disease.

Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

Disqualifiers

KEAP1 nonsense mutation (any position)

KEAP1 frameshift mutation (any position)

Any unresolved toxicity Grade ≥2 per CTCAE version 5.0 from previous anticancer treatment.

Current or prior treatment with anti-epileptic medications for the treatment or prophylaxis of seizures.

Trial design

Treatments tested in this trial

  • VVD-130037
  • Docetaxel
  • Paclitaxel
  • Pembrolizumab

Treatment groups

290 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators