A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
Arvinas Inc.
Study ID
NCT07749586
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • ARV-6723 — DRUG
    Oral daily dose of ARV-6723 at an assigned dose.
  • Pembrolizumab — DRUG
    IV infusion or SQ injection Q3W at an assigned dose.
  • SOC — DRUG
    Investigator's choice of SOC drugs.

Study Details

This is a study to evaluate the safety and potential anti-tumor activity of an investigational drug called ARV-6723, in participants with advanced solid tumors. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-6723. The investigational drug ARV-6723 will be given as an oral tablet on its own and also in combination with other drugs. Researchers think that ARV-6723 can help the body's immune system to better recognize, attack, and destroy cancer cells in adults with advanced solid tumors. ARV-6723 is an investigational drug, and this is the first time ARV-6723 will be used in humans. Depending on the treatment assignment, the investigational drug, ARV-6723, will be given as an oral tablet either on its own (monotherapy) or in combination with pembrolizumab, either through a vein (intravenously or IV) or through an injection beneath the skin (subcutaneously or SQ). This study will include multiple parts: In Part A1 (Phase 1a), different small groups of participants will receive lower to higher doses of ARV-6723 as monotherapy or in combination with standard-dose of pembrolizumab. In Part A2 (Phase 1b), two groups of participants with specific tumor indication(s) (TBD) will receive one of two doses selected based on information from Part A1. Details of Part B will be determined based on information generated from Part A.

Key Dates

First listed
Aug 6, 2026
Start date
Jul 29, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2032

Study Design

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

Arms

  • Experimental: Part A1a: Phase 1 Monotherapy dose escalation
    Participants will receive the assigned dose of ARV-6723 orally once daily (QD) in tablet form, under fasted conditions in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
  • Experimental: Part A1b: Phase 1 Combination therapy dose escalation
    Participants will receive the assigned dose of ARV-6723 orally QD in tablet form, under fasted conditions along with pembrolizumab by intravenous (IV) infusion or subcutaneous (SQ) injection at fixed dose once every 3 weeks (Q3W) in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
  • Experimental: Part A2b: Phase 1 Monotherapy dose optimization
    Participants will receive the assigned dose of ARV-6723, based on Phase A1a, orally QD in tablet form, under fasted conditions in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
  • Experimental: Part A2b: Phase 1 Combination therapy dose optimization
    Participants will receive the assigned dose of ARV-6723, based on Phase A1b orally QD in tablet form, under fasted conditions along with pembrolizumab IV infusion or SQ injection at fixed dose Q3W in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
  • Experimental: Part B: Phase 2 Monotherapy dose expansion
    Participants will receive the assigned dose of ARV-6723, selected based on Part A in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
  • Experimental: Part B: Phase 2 Combination dose expansion
    Participants will receive the assigned dose of ARV-6723, selected based on Part A in combination with pembrolizumab by IV infusion or SQ injection n 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
  • Experimental: Part B: Phase 2 Standard of care (SOC)
    Participants will receive SOC treatment regimens based on investigators choice and the tumor indications. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.

Primary Outcome Measure

Part A1: Number of Dose-Limiting Toxicities (DLTs) of ARV-6723 [ Time Frame: 21 days from first ARV-6723 administration ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Trial SiteHuntersvilleNorth Carolina28078-
Clinical Trial SiteSan AntonioTexas78229-
Clinical Trial SiteFairfaxVirginia22031-

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