A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation

Conditions

• Advanced Solid Cancer
• KRAS G12D Mutation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ARV-806 — DRUG
  Intravenous infusion at assigned dose and dosing schedule

Study Details

This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806. Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is called intravenous (IV) infusion. This study will include 2 parts. In Part A (Phase 1), different small groups of participants will receive lower to higher doses of ARV-806. Adults with advanced cancers having a specific KRAS mutation will be included. In Part B (Phase 2), participants will be assigned to receive one of up to 2 dose levels decided by the information from Part A. Part B will include participants with advanced pancreatic ductal cancer having a specific KRAS mutation.

Key Dates

Start date

May 29, 2025

Status verified

Feb 2026

Primary completion

Nov 30, 2027

Completion

Apr 2, 2029

Study Design

Enrollment

159 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1/Part A (Dose Escalation)
  Participants will receive ARV-806 at the assigned doses and regimen (weekly or every 2 weeks).
• Experimental: Phase 2/Part B (Dose Expansion)
  Participants will receive ARV-806 at one of up to 2 dose levels/regimens selected from Part A)

Primary Outcome Measure

Part A (Phase 1): Number of dose-limiting toxicities of ARV-806 [ Time Frame: 28 days from first ARV-806 administration ]

Central Contacts

• Arvinas, Inc.
  +14752245787
  [email protected]

Locations (14)

Find similar trials in Phoenix, AZ

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