NCT07023731Active, not recruitingPhase 1/2
A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 9 Jun 2025
- Start date
- May 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Arvinas Inc.
- Diseases
- Thyroid cancer, Melanoma, Endometrial cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07023731
- EU CT number
- 2025-521062-10-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 76
- From May 2025 to the primary completion date, Nov 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a KRAS G12D or a KRAS G12C targeting therapy (pan-KRAS inhibitor/degrader included)
- 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.
Other illness
- Uncontrolled hypertension despite optimal medical therapy
Other
- Part A / Part B:
- Active brain metastases
- Carcinomatous meningitis
- Participants with an inability to comply with listed prohibited treatments
- Standard 12-lead electrocardiogram that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.