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OncoMatch/Clinical Trials/NCT07749586

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

Is NCT07749586 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including ARV-6723 and Pembrolizumab for advanced solid tumor.

Phase 1/2RecruitingArvinas Inc.NCT07749586Data as of Sep 2026

Treatment: ARV-6723 · Pembrolizumab · SOCThis 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Other

ARV-6723SOC

Cancer type

Tumor Agnostic

Performance status

ECOG 0–1(Restricted strenuous activity)

ECOG PS 0 or 1 or equivalent. Participants with ECOG PS 2 may be considered upon discussion with the Sponsor Medical Monitor.

Prior therapy

Min 1 prior line

Must have received: immune checkpoint inhibitor

previously received at least one prior therapy targeting programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), cytotoxic T-lymphocyte antigen 4 (CTLA-4), lymphocyte-activation gene 3 (LAG-3), and/or another T-cell co-stimulatory or immune checkpoint pathway, in any treatment setting (including neoadjuvant or adjuvant)

Cannot have received: HPK1-targeting agent

Prior treatment with any HPK1-targeting agent

Lab requirements

Blood counts

adequate organ function

Kidney function

adequate organ function

Liver function

adequate organ function

Participants with adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Clinical Trial Site · Huntersville, North Carolina
  • Clinical Trial Site · San Antonio, Texas
  • Clinical Trial Site · Fairfax, Virginia

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07749586 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior HPK1-targeting agent disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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