Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Recurrence

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy followed by the maintenance of AN0025

250 mg or 500 mg Q.D., oral administration

AN0025

Jianming Xu, MD

This is an open-label, multicenter, phase Ib study to evaluate the safety, tolerability, and preliminary efficacy of AN0025 in combination with chemoradiotherapy (CRT) in patients with locally advanced/locally recurrent esophageal cancer.

This study will enroll patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer to assess the safety and tolerability of AN0025 at 250mg QD and 500mg QD combined with concurrent chemoradiotherapy to fix the MTD or RP2D. At RP2D level, another 20 patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer will be enrolled at PR2D dose level to explore the preliminary efficacy.

AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Chemoradiotherapy in Patients With Locally Advanced/Locally Recurrent Esophageal Cancer

DLTs are defined as study drug-related toxicities graded using Common Terminology Criteria for Adverse events of the National Cancer Institute (NCI CTCAE) V5.0 occurring during DLT period (the first 4 weeks of AN0025 administration in combination with dCRT)

The rate of patients with complete response in all tumor evaluable patients

The rate of patients with complete response and partial response in all tumor evaluable patients

The rate of patients with complete response, partial response and stable disease in all tumor evaluable patients

The duration from the date of 1st dose to imageological progression or death, which earlier

The duration from the date of 1st dose to death

Adlai Nortye Biopharma Co., Ltd.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Uterine Cervical Neoplasms

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Breast Diseases

Skin Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.

Robert Atkinson, Ph.D.

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.

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

Number of participants with Dose Limiting Toxicities (DLTs)

Merck Sharp & Dohme LLC

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Durvalumab

Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration

To evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation durvalumab in Stage III Non-Small Cell Lung Cancer participants

Salma K Jabbour, MD

Matthew Deek, MD

Salma Jabbour

Primary

* Evaluate safety and toxicity of AN0025 in both the consolidative setting (after chemoradiation) and in the concurrent setting (during chemoradiation)
* Evaluate efficacy by progression-free survival (PFS), objective response rate (ORR), and time to death or distant metastasis (TTMD), Duration of response (DOR), Overall survival (OS) with the addition of AN0025 in both the consolidative and concurrent settings Exploratory
* Evaluate pharmacokinetics of AN0025 in conjunction with chemoradiation, and then with durvalumab

The purpose of the research is to evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation durvalumab in advanced (Stage III) Non-Small Cell Lung Cancer. Participant will receive the experimental combination of drugs (AN0025, chemoradiation and durvalumab) and undergo laboratory tests and study procedures on specified days during the study period. Complete end of study evaluations and tests, and participate in post-study follow up every three months for two years. The time in the study will take approximately four to six hours during pre-study, study and end of study visits.

Possible benefits of taking part may be improvement in your condition and slowing or stopping the growth of your cancer.

This is an open-label, multicenter, phase 1 study to evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation Durvalumab therapy in patients with locally advanced Stage III NSCLC. The Phase 1a part will include dose escalations or de-escalation in three dose cohorts and a dose-limiting toxicity observation period. The Phase 1b part will be an expansion phase with twelve participants (including those enrolled at the MTD) at the recommended Phase 2 dose (RP2D) or the maximum tolerated dose level.

A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants

Response evaluation criteria in solid tumors (RECIST 1.1) will be used as the primary measure for evaluation of tumor response and date of disease progression

The performance status will be assessed according to the Eastern Cooperative Oncology Group Performance Status (ECOG) performance status scale. Eastern Cooperative Oncology Group Performance Status (ECOG) will be measured at screening, at day one of each treatment cycle and at the safety follow-up visits

A solid tumor measurement and definitions for objective change in tumor size. Immune response evaluation criteria in solid tumors (iRECIST) is based on RECIST 1.1, but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST will be used by the Investigator to assess tumor response and progression and make treatment decisions.

Rutgers, The State University of New Jersey

Professor, Vice Chair of Clinical Research and Faculty Development, Department of Radiation Oncology; Clinical Chief of the Radiation Oncology Clinic

Atezolizumab

During the DLT Observation I, patients will be treated with AN2025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN2025 is 50 mg. If tolerated, then a subsequent cohort will escalate to 100 mg. A dose de-escalation cohort to 80 mg may occur if the 100 mg is not well tolerated. The dose of Atezolizumab will remain constant at 1200 mg every 3 weeks (Q3W) for each dose level of AN2025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

During the DLT Observation II, patients will be treated with AN0025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN0025 is 250 mg. If tolerated, then a subsequent cohort will escalate to 500 mg. If 250 mg AN0025 is not tolerated, de-escalate to 125 mg. The dose of Atezolizumab will remain constant at 1200 mg Q3W for each dose level of AN0025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

The DLT Observation III will be started after safety data review by the investigators and the sponsor of the double combination treatments in Observations I and II. Patients enrolled in Observation III will start with the recommended dose of AN0025 from Observation II, 1200 mg Atezolizumab, and AN2025 will start from 50 mg QD. Patients will be treated with all three study drugs until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The dose of Atezolizumab will be the same (i.e., 1200 mg Q3W) regardless of dose levels of AN2025 and cohorts. Atezolizumab is administered intravenously over 60 minutes every three weeks. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. The dose of AN0025 as determined in Observation II will remain constant for each dose level of AN2025 and each cohort, unless the investigators and the sponsor determine that the toxicity comes from the AN0025 + Atezolizumab combination.

AN2025

Atezolizumab 1200 mg in 20 ML Injection

Robert Atkinson, PhD, MSCR

Jennifer Diamond, MD

Alexander Philipovskiy, MD, PhD

Eugenia Girda, MD, FACOG

Kristen R Spencer, DO, MPH

Susanna Ulahannan, MD

This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors.

This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors. This study consists of three DLT Observation Periods I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. In all three Observation Periods, a "6 + 3 design" will be utilized for dose finding with dose escalation and de-escalation.

Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors

An Open-Label, Multicenter, Phase 1a Study of AN2025 and AN0025 in Double Combination With Atezolizumab and in Triple Combination With Atezolizumab in Patients With Advanced Solid Tumors

The safety profile will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), by Investigator review and in accordance with RECIST 1.1.

PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurs first.

DOR is defined as the time from the earliest objective response to disease progression or death.

OS is defined as the time from the date of the first dose of study drug to the date of death.

Efficacy by PIK3CA mutation in Observation I and III

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AN0025 and Chemoradiotherapy Combination in Esophageal Cancer	NCT05191667	Esophageal Canc...	AN0025	18 Years -	Adlai Nortye Biopharma Co., Ltd.
AN0025 and Pembrolizumab Combination in Advanced Solid Tumors	NCT04432857	Triple-negative... NSCLC, Squamous... Urothelial Carc... Microsatellite ... Cervical Cancer	AN0025 Pembrolizumab	18 Years -	Adlai Nortye Biopharma Co., Ltd.
AN0025 and Chemoradiotherapy Combination in Esophageal Cancer	NCT05191667	Esophageal Canc...	AN0025	18 Years -	Adlai Nortye Biopharma Co., Ltd.
AN0025 and Chemoradiotherapy Combination in Esophageal Cancer	NCT05191667	Esophageal Canc...	AN0025	18 Years -	Adlai Nortye Biopharma Co., Ltd.
A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants	NCT05358691	Lung Cancer Sta...	AN0025	18 Years -	Rutgers, The State University of New Jersey
AN0025 and Pembrolizumab Combination in Advanced Solid Tumors	NCT04432857	Triple-negative... NSCLC, Squamous... Urothelial Carc... Microsatellite ... Cervical Cancer	AN0025 Pembrolizumab	18 Years -	Adlai Nortye Biopharma Co., Ltd.
Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors	NCT04975958	Locally Advance...	AN2025 AN0025 Atezolizumab 12...	18 Years -	Adlai Nortye Biopharma Co., Ltd.

Spots Global Cancer Trial Database for an0025

Every month we try and update this database with for an0025 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for an0025

Every month we try and update this database with for an0025 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for an0025 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.