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New drug targets Hard-to-Treat cancer mutation in first human trial

NCT ID NCT07023731

Disease control Sponsor: Arvinas Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 5 times

Summary

This study tests a new drug called ARV-806 in adults with advanced solid tumors that have a specific KRAS G12D mutation. The drug aims to break down the mutated protein that helps tumors grow. The trial has two parts: first, finding a safe dose in small groups, then testing that dose in people with advanced pancreatic cancer. About 159 participants will receive the drug intravenously.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARV-806 (a drug that breaks down a specific mutated protein in cancer cells)
What this could lead to
If it works, this could point toward a new treatment option for advanced cancers with a specific KRAS mutation, especially pancreatic cancer.
What could go wrong
This is the first time ARV-806 is tested in humans, so safety and effectiveness are unknown. The trial is small and early-stage, so results may not lead to a widely available treatment.
Why investors are watching

Arvinas runs this first-in-human trial of ARV-806, an intravenous drug that breaks down a mutated KRAS protein in advanced solid tumors. The study tests safety and dosing in Part A, then tests up to two doses in pancreatic cancer in Part B. For a small company, this readout matters because it is the first human data on the drug and shapes whether the program moves forward.

If it works: If ARV-806 proves safe and shows signs of slowing tumor growth, Arvinas could advance the program into larger studies and attract partners or additional funding.

If it fails: First-in-human trials often fail on safety or show no anti-tumor activity, and any such result would set back or end the ARV-806 program for a small company with limited resources.

AI-written from the trial record. Speculative, and not investment advice.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

76 people

The number who actually took part.

Started

May 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: * 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. Exclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus cholangiocarcinoma colonic neoplasm colorectal neoplasm endometrium neoplasm gallbladder neoplasm gastric neoplasm melanoma neoplasm non-small cell lung carcinoma ovarian cancer pancreatic ductal adenocarcinoma pancreatic neoplasm Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid cancer KRAS G12D mutation

Contacts and locations

Locations

  • Clinical Trial Site

    Phoenix, Arizona, 85004, United States

  • Clinical Trial Site

    Phoenix, Arizona, 85054, United States

  • Clinical Trial Site

    New Haven, Connecticut, 06510, United States

  • Clinical Trial Site

    Tampa, Florida, 33612, United States

  • Clinical Trial Site

    Indianapolis, Indiana, 46250, United States

  • Clinical Trial Site

    Grand Rapids, Michigan, 49546, United States

  • Clinical Trial Site

    New York, New York, 10032, United States

  • Clinical Trial Site

    New York, New York, 10065, United States

  • Clinical Trial Site

    Huntersville, North Carolina, 28078, United States

  • Clinical Trial Site

    Cleveland, Ohio, 44106, United States

  • Clinical Trial Site

    Houston, Texas, 77030-7009, United States

  • Clinical Trial Site

    San Antonio, Texas, 78229, United States

  • Clinical Trial Site

    Salt Lake City, Utah, 84112, United States

  • Clinical Trial Site

    Fairfax, Virginia, 22031, United States

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