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AN0025 and Pembrolizumab Combination in Advanced Solid Tumors | Clinical Trials | Clareo Health

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AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

NCT04432857•Adlai Nortye Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years at the time of informed consent.
•2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•3. Life expectancy ≥3 months.
•4. Diagnosed with histologically confirmed locally advanced and nonresectable, or metastatic disease.
•Patients diagnosed with one of the following tumor types:
•A. Urothelial carcinoma of the bladder B. NSCLC, Squamous or Non-Squamous C. TNBC D. Cervical cancer E. MSS CRC
•5. Have progressed on treatment with an anti-PD-1/PD-L1monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies (cohort A, B or C) and have failed available standard of care treatment or deemed inappropriate candidates for additional standard treatments by the investigator. PD-1 treatment progression is defined by meeting all of the following criteria:
•For cohort A, B and C:
•1. Has received at least 2 doses of an approved anti-PD-1/PD-L1 mAb.
•2. Has demonstrated disease progression after PD-1/PD-L1 as defined by RECIST v1.1. The initial evidence of disease progression (PD) is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression. i,ii
+31 more criteria

Exclusion Criteria

•1. Have been discontinued treatment due to a Grade 3 or higher immune-related (irAE) from prior anti-PD-1or anti-PD-L1, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
•2. Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter prior to treatment.
•Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or returned to baseline. Participants with ≤Grade 2 neuropathy may be eligible.
•3. Have received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
•4. Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non live COVID vaccinations or boosters should not occur during Cycle 1 or within 30 days prior to the first dose of study drug.
•5. Are currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.
•Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks after the last dose of the previous investigational agent.
•6. Have had an allogenic tissue/solid organ transplant.
•7. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•8. With a history of another primary malignancy within the past 2 years, with the exception of basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy.
+14 more criteria

Locations (6)

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Utah School of Medicine Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia

Richmond, Virginia, United States

Centre Léon Bérard

Lyon, France

Gustave Roussy

Paris, France

Key Dates

Start Date

August 20, 2020

Primary Completion Date

May 31, 2024

Completion Date

January 30, 2025

Last Updated

June 27, 2024

Enrollment

ACTUAL participants

Conditions

Triple-negative Breast CancerNSCLC, Squamous or Non-SquamousUrothelial Carcinoma of the BladderMicrosatellite Stable (MSS) Colorectal Cancer (CRC)Cervical Cancer

Interventions

AN0025

DRUG

Pembrolizumab

DRUG

Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

NCT05806060

Triple-Negative Breast Cancer

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RECRUITING

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

NCT05914961

TNBC - Triple-Negative Breast Cancer

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RECRUITINGNA

Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

Reverse Triple Negative Immune Resistant Breast Cancer

Study of AVZO-021 in Patients With Advanced Solid Tumors

BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia