Can a new pill help the immune system fight cancer?
NCT ID NCT07749586
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing an investigational drug called ARV-6723, given as a pill, in people with advanced solid tumors. The drug is designed to help the immune system recognize and attack cancer cells. The study will test ARV-6723 alone and in combination with pembrolizumab, an immunotherapy drug. The goal is to see if the treatment is safe and whether it can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARV-6723 (an investigational oral drug) alone or in combination with pembrolizumab (an immunotherapy)
- What this could lead to
- If ARV-6723 helps the immune system attack cancer cells, it could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is the first human study of ARV-6723, so its safety and effectiveness are unknown. The trial is early-stage and may not lead to a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 499 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical Trial Site
RECRUITINGHuntersville, North Carolina, 28078, United States
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Clinical Trial Site
RECRUITINGSan Antonio, Texas, 78229, United States
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Clinical Trial Site
RECRUITINGFairfax, Virginia, 22031, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors