Hepatocellular CarcinomaPhase 1NCT07252661
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
A Phase 1 study testing ACC-1898 in people with Hepatocellular Carcinoma and Renal Cell Carcinoma, run by AccSalus Biosciences, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Renal Cell Carcinoma, Thyroid Carcinoma, Medullary
- What is being tested?
- ACC-1898
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
- Pregnant or breastfeeding women.
- Any other medical condition that, in the investigator's judgment, would interfere with study participation or pose unacceptable risk.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hepatocellular Carcinoma, Renal Cell Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Carcinoma Primary Differentiated, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Being tested
- ACC-1898
- Keywords
- Advanced Solid Tumors, Metastatic Cancer, Tyrosine Kinase Inhibitor, VEGFR, MET, RET, AXL, Multi-target TKI, ACC-1898
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Thyroid cancer, medullary, Melanoma, Gallbladder Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACC-1898Drug
Also called ST-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.
| Study group | Role | What they receive |
|---|---|---|
| Participants receive ACC-1898 tablets orally once daily (QD) in 21-day cycles | Experimental | 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 Receives: Drug: ACC-1898 |
| ACC-1898 Dose Expansion Cohorts | Experimental | 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. Receives: Drug: ACC-1898 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Cycle 1 (each cycle = 21 days)
Treatment-Emergent Adverse Events (TEAEs)
Incidence, severity, and relationship of TEAEs graded per CTCAE v5.0.
Measured: From first dose through 28 days after last dose (up to 2 years)
Secondary outcomes (10)
Maximum Observed Plasma Concentration (Cmax) Part 1 (Pharmacokinetics)
Maximum plasma concentration after oral dosing, derived from individual plasma concentration-time profiles.
Measured: 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.
Measured: 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
Measured: Cycle 1 Day 15 (Cycle length = 21 days)
AUC₀-∞ Part 1 (Pharmacokinetics)
Total systemic exposure extrapolated to infinity after a single dose.
Measured: 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.
Measured: 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.
Measured: Cycle 1 Day 15 (Cycle length = 21 days)
Apparent Volume of Distribution (Vz/F) Part 1 (Pharmacokinetics)
Extent of drug distribution following oral administration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cycle 1 Day 15 vs Day 1 (Cycle length = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, dose-escalation study followed by expansion at the recommended dose in participants with advanced solid tumors.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AccSalus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252661
- Sponsor's protocol ID
- ACC-1898-101
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07252661
- Acronym / sponsor ID
- ACC-1898-101
- Conditions
- Hepatocellular Carcinoma, Renal Cell Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Carcinoma Primary Differentiated, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Keywords
- Advanced Solid Tumors, Metastatic Cancer, Tyrosine Kinase Inhibitor, VEGFR, MET, RET, AXL, Multi-target TKI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AccSalus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, dose-escalation study followed by expansion at the recommended dose in participants with advanced solid tumors.
| Arm | Type | Receives |
|---|---|---|
| Participants receive ACC-1898 tablets orally once daily (QD) in 21-day cycles | Experimental | Drug: ACC-1898Dose-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 |
| ACC-1898 Dose Expansion Cohorts | Experimental | Drug: ACC-1898Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACC-1898Also: ST-1898ACC-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. | Drug | ACC-1898 Dose Expansion Cohorts, Participants receive ACC-1898 tablets orally once daily (QD) in 21-day cycles |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) Part 1 (Dose Escalation)
Time frame: Cycle 1 (each cycle = 21 days)
Occurrence of DLTs within the first treatment cycle to determine the maximum tolerated dose (MTD) and/or recommended Part 2 dose (OBD).
Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through 28 days after last dose (up to 2 years)
Incidence, severity, and relationship of TEAEs graded per CTCAE v5.0.
10 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)
Area Under the Concentration-Time Curve (AUC₀-last) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)
AUC₀-τ (steady-state interval) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
AUC₀-∞ Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 1 (Cycle length = 21 days)
Terminal Half-Life (t½) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)
Apparent Oral Clearance (CL/F) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
Apparent Volume of Distribution (Vz/F) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
Minimum Observed Plasma Concentration (Cmin) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 15 (Cycle length = 21 days)
Accumulation Ratio for AUC (AR-AUC) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 15 vs Day 1 (Cycle length = 21 days)
Accumulation Ratio for Cmax (AR-Cmax) Part 1 (Pharmacokinetics)
Time frame: Cycle 1 Day 15 vs Day 1 (Cycle length = 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACC-1898 in people with Hepatocellular Carcinoma and Renal Cell Carcinoma, run by AccSalus Biosciences, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaymes Holland (6502732627, jaymes.holland@accsalus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) Part 1 (Dose Escalation) (time frame: Cycle 1 (each cycle = 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.