RecruitingPhase I/IIEN originalOther cancersMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony histologicznie lub cytologicznie nieoperacyjny lub rozsiewny nowotwór litej
  • Wcześniejsze leczenie immunoterapią skierowaną na punkty kontrolne odpowiedzi immunologicznej
  • Wcześniejsze standardowe leczenie bez dostępnych opcji terapeutycznych lub niespodziewane korzyści z dalszego leczenia
  • Udowodniony wzrost guza i co najmniej jedno zmierzone ognisko (zmiana) niezapromieniane lub z progresją po radioterapii
  • Dobry stan ogólny (ECOG 0-1)
  • Prawidłowe funkcjonowanie narządów wewnętrznych

✗ Disqualifies

  • Aktywne przerzuty do mózgu
  • Przerzuty nowotworowe do opon mózgowo-rdzeniowych
  • Znana nadwrażliwość na ARV-6723 lub pembrolizumab
  • Aktywna choroba autoimmunologiczna lub historia nawracających chorób autoimmunologicznych
  • Historia ciężkich powikłań związanych z poprzednią immunoterapią
  • Wcześniejsze leczenie podobnymi eksperymentalnymi lekami (HPK1-targeting)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 6, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (3)

Clinical Trial Site

Huntersville, United States

Clinical Trial Site

San Antonio, United States

Clinical Trial Site

Fairfax, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/7/2026.

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