RecruitingPhase 1/2

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

United States499 participantsStarted 2026-07-29

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Part A1 dose escalation and A2 dose optimization: Participants must meet all of the following criteria: * Have a histologic or cytologic diagnosis of unresectable or metastatic solid tumor malignancy. * Have 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). * Have received prior SOC therapy appropriate for their disease type and stage and have no remaining available treatment options with established clinical benefit; or, in the opinion of the investigator, are unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy; or have declined SOC therapy. * Participants must have demonstrated radiographic progression and have at least 1 measurable lesion per RECIST v1.1 that has not been previously irradiated or has demonstrated progression of disease since radiation therapy. * ECOG PS 0 or 1 or equivalent. Participants with ECOG PS 2 may be considered upon discussion with the Sponsor Medical Monitor. * Participants with adequate organ function. Exclusion Criteria: Exclusion Criteria (Part A) * Active brain metastases (new lesions identified on imaging, existing lesions showing progression per Response Evaluation Criteria in Solid Tumors, v…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A1: Number of Dose-Limiting Toxicities (DLTs) of ARV-6723

Timeframe: 21 days from first ARV-6723 administration

Part A1: Number of Participants With Adverse Events (AEs)

Timeframe: From the first dose of ARV-6723 through at least 28 days after the last dose (up to approximately 4.7 years)

Part A2: Number of Participants With AEs

Timeframe: From the first dose of ARV-6723 through at least 28 days after the last dose (up to approximately 4.7 years)

Part A2: Overall Response Rate (ORR) by computed tomography/magnetic resonance imaging (CT/MRI) Using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) Criteria Per Investigator Assessment

Timeframe: Approximately 24 months

Part B: ORR by CT/MRI using RECIST v1.1 Criteria Per Investigator Assessment

Timeframe: Approximately 24 months

Trial details

NCT IDNCT07749586

SponsorArvinas Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-03-31

Contact for this trial

Arvinas Inc.

+1 203 691 1115 ARV-6723-101-ClinicalContacts@arvinas.com

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A1: Number of Dose-Limiting Toxicities (DLTs) of ARV-6723

Timeframe: 21 days from first ARV-6723 administration

Part A1: Number of Participants With Adverse Events (AEs)

Timeframe: From the first dose of ARV-6723 through at least 28 days after the last dose (up to approximately 4.7 years)

Part A2: Number of Participants With AEs

Timeframe: From the first dose of ARV-6723 through at least 28 days after the last dose (up to approximately 4.7 years)

Timeframe: Approximately 24 months

Part B: ORR by CT/MRI using RECIST v1.1 Criteria Per Investigator Assessment

Timeframe: Approximately 24 months