Study of ACC-1898 in Adult Participants With Advanced Solid Tumors

NCT07252661 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ACC-1898-101
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hepatocellular Carcinoma; Renal Cell Carcinoma; Thyroid Carcinoma, Medullary; Thyroid Carcinoma Primary Differentiated; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Melanoma; Gall Bladder Cancer; Advanced Solid Tumor

Keywords

Advanced Solid Tumors; Metastatic Cancer; Tyrosine Kinase Inhibitor; VEGFR; MET; RET; AXL; Multi-target TKI; ACC-1898

Outcome Measures

Primary Outcomes (2)

• 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).

  Cycle 1 (each cycle = 21 days)

• Treatment-Emergent Adverse Events (TEAEs)

  Incidence, severity, and relationship of TEAEs graded per CTCAE v5.0.

  From first dose through 28 days after last dose (up to 2 years)

Secondary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax) Part 1 (Pharmacokinetics)

  Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)

• Area Under the Concentration-Time Curve (AUC₀-last) Part 1 (Pharmacokinetics)

  Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)

• AUC₀-τ (steady-state interval) Part 1 (Pharmacokinetics)

  Cycle 1 Day 15 (Cycle length = 21 days)

• AUC₀-∞ Part 1 (Pharmacokinetics)

  Cycle 1 Day 1 (Cycle length = 21 days)

• Terminal Half-Life (t½) Part 1 (Pharmacokinetics)

  Cycle 1 Day 1 and Day 15 (Cycle length = 21 days)

Study Arms (2)

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

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.

Drug: ACC-1898

Interventions

ACC-1898 DRUG

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

ACC-1898 Dose Expansion Cohorts; Participants receive ACC-1898 tablets orally once daily (QD) in 21-day cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AccSalus Biosciences, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma, Renal Cell; Thyroid cancer, medullary; Melanoma; Gallbladder Neoplasms; Neoplasm Metastasis

Interventions

3-(3'-adamantan-1-yl-4'-methoxybiphenyl-4-yl)-2-propenoic acid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jaymes Holland

CONTACT

6502732627; jaymes.holland@accsalus.com

Jaymes Holland

CONTACT

6502732627; jaymes.s.holland@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; no masking or blinding procedures are applied.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, dose-escalation study followed by expansion at the recommended dose in participants with advanced solid tumors.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share