NCT07252661Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
An Open-Label, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACC-1898 (Tyrosine Kinase Inhibitor) in Adult Participants With Advanced Solid Tumors.
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
This is a research study of an experimental drug called ACC-1898. ACC-1898 is an oral tyrosine kinase inhibitor (TKI) that blocks several proteins kinases which may help cancer cells grow and spread. The purpose of this Phase 1 clinical trial is to find a safe dose of ACC-1898 and to understand how the body absorbs, distributes, and eliminates the drug (pharmacokinetics / PK). The study will also look for early signs that ACC-1898 may slow or shrink tumors and explore possible biological markers related to drug activity. Adults with advanced or metastatic solid tumors who have no remaining standard treatment options may take part. All participants will receive ACC-1898 tablets by mouth once daily in repeating 21-day cycles. Treatment may continue for up to two years if the cancer does not worsen and side effects are manageable. Safety information, laboratory results and imaging scans (CT or MRI) will be collected regularly. The study will first test different dose levels (dose-escalation phase) and may later expand enrollment in selected tumor types once a recommended dose is found.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- Jan 2027
- Primary completion date
- Jun 2028
- Lead sponsor
- AccSalus Biosciences, Inc.
- Diseases
- Thyroid cancer, Kidney cancer, Melanoma, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT07252661
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From Jan 2027 to the primary completion date, Jun 2028
- No sites listed in no 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.
Other illness
- Known primary CNS (central nervous system) malignancy or symptomatic brain metastases requiring supraphysiologic steroids (unless stable ≥ 3 months after therapy).
- Active or uncontrolled infection (including HBV, HCV, HIV) not meeting protocol control criteria.
- HBV: Hepatitis B Virus HCV: Hepatitis C Virus HIV: Human Immunodeficiency Virus
- Significant GI disease that could impair oral drug absorption (e.g., unresolved Grade \> 1 nausea/diarrhea).
- Active liver or biliary disease (except stable metastases or Gilbert's syndrome).
- Any other medical condition that, in the investigator's judgment, would interfere with study participation or pose unacceptable risk.
Lab values
- Baseline QTcF (QT Interval Corrected Using Fridericia Formula) \> 450 msec (men) or \> 470 msec (women), clinically significant ECG abnormalities, or heart rate \< 45 bpm unless approved by cardiology review.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- Adults (≥ 18 years) with histologically confirmed advanced or metastatic solid tumors that have progressed after standard therapy or for which no effective standard option exists.
- At least one measurable lesion per RECIST v1.1.
- ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1 (2 may be allowed with Medical Monitor approval).
- Resolved acute effects from prior therapy to ≤ Grade 1 per CTCAE v5.0.
- Adequate organ function (hematologic, hepatic, renal).
- Able to swallow oral medication and comply with study requirements.
- Signed informed consent.
- Women of childbearing potential must have a negative pregnancy test and use highly effective contraception during and for 180 days after treatment; men must use condoms and avoid sperm donation for 120 days post-treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.