AzTrials
AzTrials

KRAS G12D MutationPhase 1/2NCT07023731

A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation

A Phase 1/2 study testing ARV-806 in people with KRAS G12D Mutation and Advanced Solid Cancer, run by Arvinas Inc. at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
KRAS G12D Mutation, Advanced Solid Cancer
What is being tested?
ARV-806
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
14 sitesUnited States
Study dates
29 May 2025to 30 Nov 2026
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 A:
  • Histological or cytological diagnosis of unresectable or metastatic solid tumor malignancy, AND
  • Must have evidence of KRAS G12D mutation in tumor tissue or blood (circulating tumor deoxyribonucleic acid [ctDNA]), AND
  • Must have received prior standard-of-care (SOC) therapy appropriate for their type and stage of disease and have no other available treatment options with curative intent, or, in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy, AND
  • Must have at least 1 measurable lesion
  • Part B:
Show all 14Show fewer
  • Histological or cytological diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation status confirmed by local testing of tumor tissue using a validated molecular or next-generation sequencing (NGS) testing, AND
  • Must be willing to provide archival tumor tissue or willing to undergo pretreatment biopsy, AND
  • Must have received at least one prior standard of care systemic therapy for PDAC (systemic therapy received in the neoadjuvant or adjuvant setting is allowed), AND
  • Participants must have at least 1 measurable lesion
  • Part A / Part B:
  • Eastern Cooperative Oncology Group performance status of 0 or 1,
  • Participants with adequate organ function,
  • Participants must accept and follow pregnancy prevention guidance.

Who cannot join

  • Part A / Part B:
  • Active brain metastases
  • Carcinomatous meningitis
  • Uncontrolled hypertension despite optimal medical therapy
  • Prior treatment with a KRAS G12D or a KRAS G12C targeting therapy (pan-KRAS inhibitor/degrader included)
  • Participants with an inability to comply with listed prohibited treatments
  • Systemic anticancer therapy within 2 weeks or 5 half-lives (whichever is shorter) or radiation therapy (excluding palliative radiation) within 2 weeks prior to the study intervention treatment. If the last immediate anticancer treatment contained an antibody-based agent(s), then an interval of 28 days or 5 half-lives (whichever is shorter) of the agent(s) is required prior to receiving the study intervention treatment.
  • Standard 12-lead electrocardiogram that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Clinical Trial Site

    Cleveland, Ohio, 44106

  • Clinical Trial Site

    Fairfax, Virginia, 22031

  • Clinical Trial Site

    Grand Rapids, Michigan, 49546

  • Clinical Trial Site

    Houston, Texas, 77030-7009

  • Clinical Trial Site

    Huntersville, North Carolina, 28078

  • Clinical Trial Site

    Indianapolis, Indiana, 46250

  • Clinical Trial Site

    New Haven, Connecticut, 06510

  • Clinical Trial Site

    New York, New York, 10032

  • Clinical Trial Site

    New York, New York, 10065

  • Clinical Trial Site

    Phoenix, Arizona, 85004

  • Clinical Trial Site

    Phoenix, Arizona, 85054

  • Clinical Trial Site

    Salt Lake City, Utah, 84112

  • Clinical Trial Site

    San Antonio, Texas, 78229

  • Clinical Trial Site

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated Advanced Solid Tumors

This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806.

Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is called intravenous (IV) infusion.

Read more

This study will include 2 parts:

In Part A (Phase 1), different small groups of participants will receive lower to higher doses of ARV-806. Adults with advanced cancers having a specific KRAS mutation will be included.

In Part B (Phase 2), participants will be assigned to receive one of up to 2 dose levels decided by the information from Part A. Part B will include participants with advanced pancreatic ductal cancer having a specific KRAS mutation.

Being tested
ARV-806
Keywords
KRAS G12D Mutation, Advanced Solid Tumors, KRAS G12D Mutated Advanced Solid Tumors, KRAS G12D Mutated Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, PDAC, Non-Small Cell Lung Cancer, NSCLC, Colorectal Cancer, Colon Cancer, CRC, Appendiceal Carcinoma, Cholangiocarcinoma, Endometrial Cancer, Esophageal Adenocarcinoma, Gallbladder Cancer, Gastric Cancer, Melanoma, Ovarian Cancer, Small Bowel Adenocarcinoma
Medical subject headings
Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Colonic Neoplasms, Cholangiocarcinoma, Endometrial Neoplasms, Adenocarcinoma Of Esophagus, Gallbladder Neoplasms

What participants receive

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

  • ARV-806Drug

    Intravenous infusion at assigned dose and dosing schedule

Study groups in NCT07023731
Study groupRoleWhat they receive
Phase 1/Part A Monotherapy (Dose Escalation)ExperimentalParticipants will receive ARV-806 at the assigned doses and regimen (weekly or every 2 weeks).
Receives: Drug: ARV-806
Phase 2/Part B Monotherapy (Dose Expansion)ExperimentalParticipants will receive ARV-806 at one of up to 2 dose levels/regimens selected from Part A)
Receives: Drug: ARV-806

What is being measured

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

  1. Part A (Phase 1): Number of dose-limiting toxicities (DLTs) of ARV-806

    Number of participants within a dose escalation cohort with adverse events (AEs) meeting protocol defined dose limiting toxicities during cycle 1 (28 days).

    Measured: 28 days from first ARV-806 administration

  2. Part A (Phase 1): 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 study baseline to at least 28 days after last dose of ARV-806

  3. Part B (Phase 2): Overall Response Rate (ORR)

    ORR is a parameter measuring the anti-tumor activity of ARV-806. ORR is the percentage of participants for whom the study treatment resulted in a complete response or partial response of the disease under study. It is measured using CT/MRI and RECIST 1.1 criteria per investigator assessment.

    Measured: Approximately 2 years

Secondary outcomes (16)

  1. Pharmacokinetics (PK) of ARV-806 (Part A): 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 6 months after first dose of ARV-806

  2. PK of ARV-806 (Part A): 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 6 months after first dose of ARV-806

  3. PK of ARV-806 (Part A): Maximum plasma or blood concentration (Cmax)

    Measured: At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806

  4. PK of ARV-806 (Part A): Minimum observed concentration (Cmin)

    Measured: Timeframe: At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806

  5. PK of ARV-806 (Part A): Plasma or blood clearance (CL)

    Measured: At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806

  6. PK of ARV-806 (Part A): Time for Cmax (Tmax)

    Measured: At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806

  7. PK of ARV-806 (Part A): Volume of distribution (Vd)

    Measured: At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806

  8. Part A: Overall Response Rate (ORR)

    Measured: Approximately 2 years

  9. Part A: Time to Response (TTR)

    Measured: Approximately 2 years

  10. Part A: Duration of Response (DOR)

    Measured: Approximately 2 years

  11. Part A: Disease Control Rate (DCR)

    Measured: Approximately 2 years

  12. Part B: Number of participants with AEs

    Measured: From the study baseline to at least 28 days after last dose of ARV-806

  13. Part B: ARV-806 whole blood pre and post dose concentration

    Measured: At predefined intervals throughout the treatment period, up to approximately 6 months after first dose of ARV-806

  14. Part B: Time to Response (TTR)

    Measured: Approximately 2 years

  15. Part B: Duration of Response (DOR)

    Measured: Approximately 2 years

  16. Part B: Disease Control Rate (DCR)

    Measured: Approximately 2 years

Timeline

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

  1. First posted17 Jun 2025
  2. Study start29 May 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07023731
Sponsor's protocol ID
ARV-806-101
Other IDs
2025-521062-10-00, 2025
Status last verified
Sep 2026
First submitted
9 Jun 2025
Last updated
16 Sep 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-806 in people with KRAS G12D Mutation and Advanced Solid Cancer, run by Arvinas Inc. at 14 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 14 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A (Phase 1): Number of dose-limiting toxicities (DLTs) of ARV-806 (time frame: 28 days from first ARV-806 administration). The study lists 3 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 NCT07023731.

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 16 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in