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AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

NCT04432857 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-06-27

No results posted yet for this study

Summary

This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.

Conditions

  • Triple-negative Breast Cancer
  • NSCLC, Squamous or Non-Squamous
  • Urothelial Carcinoma of the Bladder
  • Microsatellite Stable (MSS) Colorectal Cancer (CRC)
  • Cervical Cancer

Interventions

DRUG

AN0025

oral administration

DRUG

Pembrolizumab

Infusion

Sponsors & Collaborators

Principal Investigators

  • Robert Atkinson, Ph.D. · Adlai Nortye US Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2024-05-31
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04432857 on ClinicalTrials.gov