ARV-806 for Cancer

Recruiting at 3 trial locations

Overseen By Arvinas, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Arvinas Inc.

Must not be taking: KRAS inhibitors

Disqualifiers: Brain metastases, Carcinomatous meningitis, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

159 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and potential effectiveness of a new drug, ARV-806, for advanced cancer patients with a specific KRAS mutation. Researchers believe ARV-806 could help break down a mutated protein in tumors, possibly slowing or stopping their growth. Part A of the trial will test different doses in adults with advanced cancer, while Part B will focus on those with advanced pancreatic cancer. Candidates for the trial have advanced cancer with the KRAS mutation and have not found success with other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic anticancer therapy at least 2 weeks before starting the study treatment. If your last treatment was an antibody-based agent, you need to wait 28 days or 5 half-lives, whichever is shorter, before starting the trial.

Is there any evidence suggesting that ARV-806 is likely to be safe for humans?

Research shows that ARV-806 is undergoing its first tests in humans. As this is the initial human study, no previous information exists about its safety in people. This early-phase study aims to determine the best dose and identify any side effects.

Earlier lab tests demonstrated that ARV-806 was very effective against cancer cells, suggesting potential efficacy, though human reactions can differ. The study will begin with small groups, gradually increasing the dose while closely monitoring for negative effects. This careful approach prioritizes safety. Participants will receive close monitoring throughout the trial to address any potential issues promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about ARV-806 because it introduces a novel approach to cancer treatment by utilizing targeted protein degradation. Unlike traditional cancer therapies that often involve chemotherapy or radiation, which can affect both healthy and cancerous cells, ARV-806 specifically targets and degrades proteins that are essential for cancer cell survival. This precision reduces potential side effects and enhances effectiveness. Additionally, ARV-806 is being tested in different dosing regimens, providing flexibility in treatment plans and potentially improving patient outcomes.

What evidence suggests that ARV-806 might be an effective treatment for advanced cancer with a specific KRAS mutation?

Research has shown that ARV-806 may help treat cancers with a specific KRAS mutation. In lab tests, ARV-806 significantly reduced tumor size, with some tumors shrinking by more than 30%. The drug targets and breaks down a mutated protein that aids tumor growth, potentially stopping or slowing cancer progression. Although ARV-806 has not yet been tested in humans, its method offers hope for treating difficult cancers like pancreatic, colorectal, and lung cancer. Early data suggests that ARV-806 could be a powerful new tool in fighting these cancers. Participants in this trial will receive ARV-806 in either a dose escalation phase or a dose expansion phase to evaluate its safety and effectiveness. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancers that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without cure, or be unlikely to benefit from them. They need at least one measurable tumor and good organ function. People who can't join include those without the KRAS G12D mutation or inadequate organ function.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, has a KRAS G12D mutation, and I have tried standard treatments.

I am mostly active, have good organ function, and agree to follow pregnancy prevention advice.

I have advanced pancreatic cancer with a specific KRAS mutation and have tried at least one standard treatment.

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, Participants with an inability to comply with listed prohibited treatments, Systemic anticancer therapy within 2 weeks or 5 half-lives, radiation therapy within 2 weeks prior to the study intervention treatment, Standard 12-lead electrocardiogram that demonstrates clinically relevant abnormalities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Participants receive ARV-806 at escalating doses to evaluate safety and tolerability

28 days

Weekly or every 2 weeks

Phase 2: Dose Expansion

Participants receive ARV-806 at selected dose levels to evaluate anti-tumor activity

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ARV-806

Trial Overview ARV-806, an investigational drug given by IV infusion, is being tested in two parts: Phase 1 (Part A) tests increasing doses on small groups; Phase 2 (Part B) uses the best dose levels from Part A on patients with advanced pancreatic cancer having the KRAS G12D mutation.

How Is the Trial Designed?

Group I: Phase 2/Part B (Dose Expansion) Experimental Treatment 1 Intervention

Participants will receive ARV-806 at one of up to 2 dose levels/regimens selected from Part A)

Group II: Phase 1/Part A (Dose Escalation) Experimental Treatment 1 Intervention

Participants will receive ARV-806 at the assigned doses and regimen (weekly or every 2 weeks).

Who Is Running the Clinical Trial?

Arvinas Inc.

Lead Sponsor

Trials

4

Recruited

730+

Citations

1. ir.arvinas.com ir.arvinas.com/news-releases/news-release-details/arvinas-presents-preclinical-data-arv-806-demonstrating-robust

Press Release Details ARV-806 demonstrated robust efficacy responses at low doses in tumor models including: ≥30% tumor volume reductions in pancreatic and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07023731

NCT07023731 | A Study to Evaluate ARV-806 in Adults ... 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 ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-04729

A Study to Evaluate ARV-806 in Adults With Advanced ... 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 ...

4. ir.arvinas.com ir.arvinas.com/news-releases/news-release-details/arvinas-present-preclinical-data-arv-806-protac-kras-g12d

Arvinas to Present Preclinical Data for ARV-806, a ... Therefore, ARV-806 has the potential to address high unmet need in solid tumors, such as pancreatic, colorectal and lung cancer. ARV‑806 is ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07023731/a-study-to-evaluate-arv-806-in-adults-with-advanced-cancer-that-has-the-kras-g12d-mutation

A Study to Evaluate ARV-806 in Adults With Advanced ... 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 ...

6. cancer.columbia.edu cancer.columbia.edu/cancer-types-care/clinical-trials/find-clinical-trial/phase-1-2-clinical-trial-evaluate-safety-tolerability-and-pharmacokinetics-arv-806-participants-kras-g12d-mutated-advanced-solid-tumors

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability ... The purpose of this study is to test ARV-806 in people who have advanced cancer with KRAS G12D mutation. Advanced cancer is cancer that has spread or come back.