Clinical trial for Advanced Solid Tumor
Official title A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07749586
What this study is testing
What is ARV-6723?
an investigational oral tablet being studied as a potential treatment for advanced solid tumors
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ARV-6723, alone or with pembrolizumab, is safe and shows anti‑tumor activity in adults with advanced solid tumors.
- Who it's for
- You may be able to join if you are an adult with an advanced solid tumor.
- What's involved
- You will take an ARV-6723 tablet by mouth, and may also receive pembrolizumab by IV or injection. You will have regular doctor visits and tests to check safety and tumor response.
- Time commitment
- The study lasts several months with multiple visits, including dose‑finding visits and follow‑up checks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have received prior SOC therapy appropriate for their disease type and stage and have no remaining available treatment options with established...
- Participants must have demonstrated radiographic progression and have at least 1 measurable lesion per RECIST v1.1 that has not been previously...
- ECOG PS 0 or 1 or equivalent. Participants with ECOG PS 2 may be considered upon discussion with the Sponsor Medical Monitor.
You likely can't join if
- Exclusion Criteria (Part A)
- Active brain metastases (new lesions identified on imaging, existing lesions showing progression per Response Evaluation Criteria in Solid Tumors...
- 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.
See the full eligibility 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)...
- Have received prior SOC therapy appropriate for their disease type and stage and have no remaining available treatment options with established clinical benefit
- 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...
- 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 (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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
- Huntersville, North Carolina, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States; Huntersville, North Carolina, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.