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Advanced Solid TumorPhase 1/2NCT07749586

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

A Phase 1/2 study testing ARV-6723, Pembrolizumab and SOC in people with Advanced Solid Tumor, run by Arvinas Inc. at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ARV-6723, Pembrolizumab and SOC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
499 participants
Where
4 sitesUnited States
Study dates
29 Jul 2026to 31 Mar 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arvinas Inc. contact

+1 203 691 1115

ARV-6723-101-ClinicalContacts@arvinas.com

United States4 sites, 4 recruiting

  • Clinical Trial Site

    Fairfax, Virginia, 22031

    Recruiting

  • Clinical Trial Site

    Huntersville, North Carolina, 28078

    Recruiting

  • Clinical Trial Site

    New York, New York, 10032

    Recruiting

  • Clinical Trial Site

    San Antonio, Texas, 78229

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ARV-6723 Administered as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

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.

Read more

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.

Being tested
ARV-6723, Pembrolizumab, SOC
Keywords
Advanced solid tumors, PROTAC, HPK1, MAP4K1, Immune checkpoint inhibitor, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC), Melanoma, Gastric cancer, Gastroesophageal cancer, Esophageal cancer, Head and Neck Squamous cell carcinoma (HSNCC), Urothelial carcinoma (UC), Colorectal Cancer (CRC), Triple-negative breast cancer (TNBC), Ovarian cancer, Cervical cancer, Merkel cell carcinoma, Skin squamous cell carcinoma (SCC), Nasopharyngeal carcinoma
Medical subject headings
Hereditary Sensory and Autonomic Neuropathies, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma, Stomach Neoplasms, Esophageal Neoplasms, Carcinoma, Transitional Cell, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARV-6723Drug

    Oral daily dose of ARV-6723 at an assigned dose.

  • PembrolizumabDrug

    IV infusion or SQ injection Q3W at an assigned dose.

  • SOCDrug

    Investigator's choice of SOC drugs.

Study groups in NCT07749586
Study groupRoleWhat they receive
Part A1a: Phase 1 Monotherapy dose escalationExperimentalParticipants will receive the assigned dose of ARV-6723 orally once daily (QD) in tablet form, under fasted conditions in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
Receives: Drug: ARV-6723
Part A1b: Phase 1 Combination therapy dose escalationExperimentalParticipants will receive the assigned dose of ARV-6723 orally QD in tablet form, under fasted conditions along with pembrolizumab by intravenous (IV) infusion or subcutaneous (SQ) injection at fixed dose once every 3 weeks (Q3W) in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
Receives: Drug: ARV-6723; Drug: Pembrolizumab
Part A2b: Phase 1 Monotherapy dose optimizationExperimentalParticipants will receive the assigned dose of ARV-6723, based on Phase A1a, orally QD in tablet form, under fasted conditions in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
Receives: Drug: ARV-6723
Part A2b: Phase 1 Combination therapy dose optimizationExperimentalParticipants will receive the assigned dose of ARV-6723, based on Phase A1b orally QD in tablet form, under fasted conditions along with pembrolizumab IV infusion or SQ injection at fixed dose Q3W in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
Receives: Drug: ARV-6723; Drug: Pembrolizumab
Part B: Phase 2 Monotherapy dose expansionExperimentalParticipants will receive the assigned dose of ARV-6723, selected based on Part A in 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
Receives: Drug: ARV-6723
Part B: Phase 2 Combination dose expansionExperimentalParticipants will receive the assigned dose of ARV-6723, selected based on Part A in combination with pembrolizumab by IV infusion or SQ injection n 21-day cycles. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
Receives: Drug: ARV-6723; Drug: Pembrolizumab
Part B: Phase 2 Standard of care (SOC)ExperimentalParticipants will receive SOC treatment regimens based on investigators choice and the tumor indications. Treatment will continue at the investigator's discretion until disease progression, unacceptable toxicity, withdrawal of consent or death.
Receives: Drug: SOC

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (21 days).

    Measured: 21 days from first ARV-6723 administration

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

    AEs as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]), timing, seriousness, and relationship to study intervention as a measure of safety and tolerability.

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

  3. Part A2: Number of Participants With AEs

    AEs as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]), timing, seriousness, and relationship to study intervention as a measure of safety and tolerability.

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

  4. 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

    ORR is defined as the proportion of participants reaching a confirmed complete response (CR) or partial response (PR) to the study treatment based on investigator assessment using RECIST 1.1 criteria.

    Measured: Approximately 24 months

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

    ORR is defined as the proportion of participants reaching a confirmed complete response (CR) or partial response (PR) to the study treatment based on investigator assessment using RECIST 1.1 criteria.

    Measured: Approximately 24 months

Secondary outcomes (20)

  1. Part A1: Area Under the Plasma or Blood Concentration-Time Profile During a Dosing Interval (AUCtau)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  2. Part A1: Area Under the Plasma or Blood Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (Clast) (AUClast)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  3. Part A1: Maximum Plasma or Blood Concentration (Cmax)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  4. Part A1: Lowest Plasma Concentration Immediately Prior to Dosing(Ctrough)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  5. Part A1: Apparent Plasma Clearance at Steady State (CL/F)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  6. Part A1: Time to Maximum Observed Plasma Concentration (Tmax)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  7. Part A1: Apparent Volume of Distribution Divided by the Bioavailability of the Drug (Vz/F)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  8. Part A1: Terminal Elimination Half-Life (t½)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  9. Part A1: Effective Terminal Elimination Half-Life (t½)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  10. Part A1: Accumulation Ratio (Rac)

    Measured: At predefined intervals throughout the treatment period, up to approximately 9 months after first dose.

  11. Part A1: Overall Response Rate (ORR)

    Measured: Approximately 24 months

  12. Part A1: Disease Control Rate (DCR)

    Measured: Approximately 24 months

  13. Part A2: ORR by CT/MRI using iRECIST Criteria Per Investigator Assessment

    Measured: Approximately 24 months

  14. Part A2: Disease Control Rate (DCR) by CT/MRI using RECIST 1.1 and iRECIST criteria per investigator assessment

    Measured: Approximately 24 months

  15. Part B: ORR by CT/MRI Using iRECIST Criteria Per Investigator Assessment

    Measured: Approximately 24 months

  16. Part B: Progression-Free Survival (PFS)

    Measured: Approximately 24 months

  17. Part B: Time to Response (TTR)

    Measured: Approximately 24 months

  18. Part B: Duration of Response (DOR)

    Measured: Approximately 24 months

  19. Part B: DCR by CT/MRI using RECIST v1.1 and iRECIST Criteria Per Investigator assessment

    Measured: Approximately 24 months

  20. Part B: Number of Participants With AEs

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start29 Jul 2026
  3. Primary completion31 Mar 2031 (estimated)
  4. Study completion31 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
499 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749586
Sponsor's protocol ID
ARV-6723-101
Other IDs
2026-525614-57-00
Status last verified
Oct 2026
First submitted
17 Jul 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARV-6723, Pembrolizumab and SOC in people with Advanced Solid Tumor, run by Arvinas Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arvinas Inc. (+1 203 691 1115, ARV-6723-101-ClinicalContacts@arvinas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A1: Number of Dose-Limiting Toxicities (DLTs) of ARV-6723 (time frame: 21 days from first ARV-6723 administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07749586.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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