ARV-6723 alone or with pembrolizumab in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-part study evaluates the safety and potential anti-tumor activity of ARV-6723 in adults with unresectable or metastatic solid tumors. Participants may receive ARV-6723 alone or combined with pembrolizumab, administered IV or SQ/o oral tablet, across dose-escalation and optimization parts. The trial includes standard-of-care comparisons and relies on prior exposure to checkpoint inhibitors or related therapies. Primary goals focus on safety, tolerability, and preliminary efficacy signals to guide future development.

Why it matters

Who can join: the full rules

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, version 1.1 (RECIST v1.1)/imaging characteristics or by clinical criteria, lesions requiring active interventions for symptom control).
* Carcinomatous meningitis.
* Known or suspected hypersensitivity to ARV-6723 or pembrolizumab or any of its excipients.
* Active autoimmune disease or history of autoimmune diseases that may relapse.
* History of severe immune-related adverse events (irAE) attributed to prior anti-PD-1/anti-CTLA-4/anti-LAG-3 therapy.
* Prior treatment with any HPK1-targeting agent
* Systemic anti-cancer therapy or radiation therapy within 14 days prior to study treatment start.
* Current use of any prohibited concomitant medication(s) or herbal supplements which cannot be discontinued, prior to start of study intervention and for the duration of the study.
* Baseline (screening) standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Where it's running

• Clinical Trial Site
  New York, New York, United States Recruiting
• Clinical Trial Site
  Huntersville, North Carolina, United States Recruiting
• Clinical Trial Site
  San Antonio, Texas, United States Recruiting
• Clinical Trial Site
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Arvinas Inc.
• Email: ARV-6723-101-ClinicalContacts@arvinas.com
• Phone: +1 203 691 1115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.