A Phase 1 interventional study of ACC-1898 in Hepatocellular Carcinoma, Renal Cell Carcinoma and Thyroid Carcinoma, Medullary, sponsored by AccSalus Biosciences, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by AccSalus Biosciences, Inc. · Phase 1, Interventional, and Treatment
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.
Study Design:
ACC-1898-101 is an open-label, multicenter, interventional Phase 1 study sponsored by AccSalus Biosciences Inc. (IND #177222). The trial evaluates the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ACC-1898 in adults with advanced solid tumors that are unresponsive to or ineligible for standard therapies.
Rationale:
Aberrant activation of receptor tyrosine kinases (RTKs) drives tumor proliferation, angiogenesis, and resistance to therapy.
ACC-1898 (also known as ST-1898) is a small-molecule inhibitor designed to block several RTK pathways simultaneously. Nonclinical studies demonstrated broad antitumor activity and favorable oral bioavailability, while early clinical experience (≈ 100 patients in prior Asian trials) showed a manageable safety profile with preliminary efficacy.
Objectives:
Primary - determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) and characterize safety.
Secondary - define PK parameters (Cmax, AUC, t½, CL/F, Vz/F) after single and repeated dosing.
AUC: Area Under the Plasma Concentration-Time Curve t½: Terminal Elimination Half-Life CL/F: Apparent Oral Clearance Vz/F: Apparent Volume of Distribution
Exploratory - evaluate objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and biomarker or PK/PD correlations.
Methods:
Approximately 40 participants will be enrolled during the dose-escalation part (Part 1) using an Accelerated Titration → Bayesian Optimal Interval (ATD (Accelerated Titration Design) -BOIN) design with planned dose levels of 80-300 mg once daily.
Treatment continues in 21-day cycles until disease progression, unacceptable toxicity, withdrawal, or study completion.
After identification of an MTD or recommended Part 2 dose, expansion cohorts may be opened for selected tumor types
Assessments:
Safety evaluations include adverse events (AEs), clinical laboratory tests, vital signs and imaging per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1.
PK sampling occurs intensively on Cycle 1 Day 1 and 15 and at steady-state in subsequent cycles.
Duration:
Each participant's involvement includes up to 28 days for screening, treatment for up to 2 years, and safety follow-up approximately 28 days after the last dose.
Data Oversight:
A Cohort Review Committee (CRC) serves as the data-monitoring body to review emerging safety and PK data before escalation or expansion decisions.
Benefit-Risk Consideration:
For patients with no remaining standard therapy, ACC-1898 offers a rational mechanism to target multiple oncogenic RTKs in a single oral agent. Known class-related risks are proactively managed through eligibility criteria, close monitoring, and prespecified dose-modification rules.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 40 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →This is the only study on the registry with AccSalus Biosciences, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults (≥ 18 years) with confirmed advanced or solid tumors that have progressed after standard therapy or for which no effective standard option exists.
At least one per v1.1.
(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 v5.0.
Adequate organ function (hematologic, hepatic, renal).
Able to swallow oral medication and comply with study requirements.
Signed .
Women of must have a negative pregnancy test and use highly effective during and for 180 days after treatment; men must use condoms and avoid sperm donation for 120 days post-treatment.
Exclusion Criteria (highlights):
Known primary CNS (central nervous system) or symptomatic requiring supraphysiologic (unless stable ≥ 3 months after therapy).
Active or uncontrolled infection (including , , ) 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 or Gilbert's syndrome).
Baseline (QT Interval Corrected Using Fridericia Formula) > 450 msec (men) or > 470 msec (women), abnormalities, or heart rate \< 45 bpm unless approved by cardiology review.
Pregnant or breastfeeding women.
Any other medical condition that, in the investigator's judgment, would interfere with study participation or pose unacceptable risk.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose-Escalation (Part 1): Determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) using an Accelerated Titration → Bayesian Optimal Interval (ATD-BOIN) design. Treatment continues until disease progression, unacceptable toxicity, withdrawal, or study completion
Drug: ACC-1898
Participants will receive ACC-1898 tablets orally once daily (QD) in repeating 21-day cycles at dose levels determined from Part 1 (dose escalation). This Phase 1b dose-expansion phase will enroll patients with selected advanced or metastatic solid tumors to further characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ACC-1898 at the recommended Part 2 dose(s). Up to three tumor-specific expansion cohorts may be opened. Within each indication, participants may be randomized between two ACC-1898 dose levels that demonstrated acceptable safety and evidence of activity in Part 1. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study completion. Paired tumor biopsies and optional blood samples will be collected to explore biomarker and PK/PD correlations.
Drug: ACC-1898
ACC-1898 is an oral small-molecule tyrosine kinase inhibitor (TKI). Administered once daily by mouth in continuous 21-day cycles. Starting doses range from 80 mg to 300 mg QD, with possible intra-patient dose modifications. Arm(s)/Group(s): * Arm 1 - ACC-1898 Monotherapy * Arm 2 - ACC-1898 Monotherapy Route of Administration: Oral (tablet) Dose Form: Film-coated tablet (20 mg and 40 mg strengths) Treatment Duration: Up to 2 years or until disease progression or unacceptable toxicity.
Also known as: ST-1898
Incidence of Dose-Limiting Toxicities (DLTs) Part 1 (Dose Escalation)
Occurrence of DLTs within the first treatment cycle to determine the maximum tolerated dose (MTD) and/or recommended Part 2 dose (OBD).
Time frame: Cycle 1 (each cycle = 21 days)
Treatment-Emergent Adverse Events (TEAEs)
Incidence, severity, and relationship of TEAEs graded per CTCAE v5.0.
Time frame: From first dose through 28 days after last dose (up to 2 years)
Maximum Observed Plasma Concentration (Cmax) Part 1 (Pharmacokinetics)
Maximum plasma concentration after oral dosing, derived from individual plasma concentration-time profiles.
Time frame: Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)
Area Under the Concentration-Time Curve (AUC₀-last) Part 1 (Pharmacokinetics)
Total drug exposure from dosing to last measurable concentration.
Time frame: Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)
AUC₀-τ (steady-state interval) Part 1 (Pharmacokinetics)
Exposure during one 24-hour dosing interval at steady state
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
AUC₀-∞ Part 1 (Pharmacokinetics)
Total systemic exposure extrapolated to infinity after a single dose.
Time frame: Cycle 1 Day 1 (Cycle length = 21 days)
Terminal Half-Life (t½) Part 1 (Pharmacokinetics)
Time for plasma concentration to decrease by 50 % during terminal phase.
Time frame: Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)
Apparent Oral Clearance (CL/F) Part 1 (Pharmacokinetics)
Dose/AUC representing systemic clearance after oral dosing.
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
Apparent Volume of Distribution (Vz/F) Part 1 (Pharmacokinetics)
Extent of drug distribution following oral administration.
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
Minimum Observed Plasma Concentration (Cmin) Part 1 (Pharmacokinetics)
Trough plasma level within dosing interval at steady state.
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
Accumulation Ratio for AUC (AR-AUC) Part 1 (Pharmacokinetics)
Ratio of AUC after repeated versus single dosing.
Time frame: Cycle 1 Day 15 vs Day 1 (Cycle length = 21 days)
Accumulation Ratio for Cmax (AR-Cmax) Part 1 (Pharmacokinetics)
Ratio of Cmax after repeated versus single dosing.
Time frame: Cycle 1 Day 15 vs Day 1 (Cycle length = 21 days)
No study locations are listed for this record.
Plan to share: No — This early-phase, first-in-human study is designed primarily to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACC-1898. Individual participant data (IPD) will not be shared publicly because the dataset may contain information that could compromise participant privacy or study integrity and is not suitable for broader distribution at this stage of development. Aggregate summaries of safety and pharmacokinetic results may be provided in future scientific publications or regulatory submissions.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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