Skip to content
DataLookout
Start free
Menu

NCT07252661

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

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from AccSalus Biosciences, Inc.

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2027 to Jun 2028 Show 4 more changesShow less
    • Start date: Jan 2026 to Jan 2027
    • Eligibility criteria revised
    • Study completion pushed from Dec 2027 to Dec 2028
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of Dose-Limiting Toxicities (DLTs) Part 1 (Dose Escalation)
Timeframe: Cycle 1 (each cycle = 21 days)
Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose through 28 days after last dose (up to 2 years)

Secondary (10)

Maximum Observed Plasma Concentration (Cmax) Part 1 (Pharmacokinetics)
Area Under the Concentration-Time Curve (AUC₀-last) Part 1 (Pharmacokinetics)
AUC₀-τ (steady-state interval) Part 1 (Pharmacokinetics)
AUC₀-∞ Part 1 (Pharmacokinetics)
Terminal Half-Life (t½) Part 1 (Pharmacokinetics)
Show 5 moreShow less
Apparent Oral Clearance (CL/F) Part 1 (Pharmacokinetics)
Apparent Volume of Distribution (Vz/F) Part 1 (Pharmacokinetics)
Minimum Observed Plasma Concentration (Cmin) Part 1 (Pharmacokinetics)
Accumulation Ratio for AUC (AR-AUC) Part 1 (Pharmacokinetics)
Accumulation Ratio for Cmax (AR-Cmax) Part 1 (Pharmacokinetics)

Arms and interventions

Participants receive ACC-1898 tablets orally once daily (QD) in 21-day cyclesExperimental

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

ACC-1898 Dose Expansion CohortsExperimental

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.

Drugs: ACC-1898