A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Conditions

• Advanced Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VVD-159642 — DRUG
  Oral capsules
• Sotorasib — DRUG
  Oral tablets
• Trametinib — DRUG
  Oral tablets

Study Details

A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.

Key Dates

Start date

Feb 25, 2025

Status verified

Mar 2026

Primary completion

Aug 1, 2027

Completion

Aug 1, 2027

Study Design

Enrollment

220 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Dose Escalation: VVD-159642 Single Agent
  Participants will receive ascending doses of VVD-159642, orally, daily in 21-day treatment cycles during Part 1.
• Experimental: Part 2: Dose Expansion (Cohort A): VVD-159642 Single Agent
  Participants will receive VVD-159642 at the recommended dose for expansion (RDE), orally, daily in 21-day treatment cycles during Part 2.
• Experimental: Part 2: Dose Expansion (Cohort B): VVD-159642 + Sotorasib
  Participants will receive VVD-159642 at RDE orally, daily in combination with sotorasib, in 21-day treatment cycles after a safety run-in.
• Experimental: Part 2: Dose Expansion (Cohort C): VVD-159642 + Trametinib
  Participants will receive VVD-159642 at RDE orally, daily in combination with trametinib, in 21-day treatment cycles after a safety run-in.

Primary Outcome Measure

Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs) [ Time Frame: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] ]

Central Contacts

• Vividion Clinical Trial Call Center
  858-345-9752
  [email protected]

Locations (7)

Find similar trials in Grand Rapids, MI

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