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

NCT07252661 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • AccSalus Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07252661 on ClinicalTrials.gov