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AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04432857
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Adlai Nortye Biopharma Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer NSCLC, Squamous or Non-Squamous Urothelial Carcinoma of the Bladder Microsatellite Stable (MSS) Colorectal Cancer (CRC) Cervical Cancer Drug: AN0025 Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Ph1a: Urothelial carcinoma of the bladder and NSCLC
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Drug: AN0025
oral administration
Other Name: E7046

Drug: Pembrolizumab
Infusion
Other Names:
  • Keytruda
  • MK3475-879

Experimental: Phase 1b: Urothelial carcinoma of the bladder
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Drug: AN0025
oral administration
Other Name: E7046

Drug: Pembrolizumab
Infusion
Other Names:
  • Keytruda
  • MK3475-879

Experimental: Phase 1b: Non-Small Cell Lung Cancer (NSCLC)
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Drug: AN0025
oral administration
Other Name: E7046

Drug: Pembrolizumab
Infusion
Other Names:
  • Keytruda
  • MK3475-879

Experimental: Phase 1b: Triple-negative breast cancer (TNBC)
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Drug: AN0025
oral administration
Other Name: E7046

Drug: Pembrolizumab
Infusion
Other Names:
  • Keytruda
  • MK3475-879

Experimental: Phase 1b: Cervical
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Drug: AN0025
oral administration
Other Name: E7046

Drug: Pembrolizumab
Infusion
Other Names:
  • Keytruda
  • MK3475-879

Experimental: Phase 1b: Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Drug: AN0025
oral administration
Other Name: E7046

Drug: Pembrolizumab
Infusion
Other Names:
  • Keytruda
  • MK3475-879




Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: 3 weeks ]
    Number of participants with Dose Limiting Toxicities (DLTs)


Secondary Outcome Measures :
  1. ORR and Progression-Free Survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: 2 years ]
  2. Duration of Response (DOR) [ Time Frame: 2 years ]
  3. Overall Survival (OS) [ Time Frame: 2 years ]
  4. Efficacy by PD-L1 expression [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Diagnosed with histologically confirmed locally advanced and nonresectable, or metastatic disease.

Phase 1a:

Patients with urothelial carcinoma of the bladder, or squamous or non-Squamous NSCLC

Phase 1b Expansion Cohort:

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

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 (phase 1a, phase 1b cohort A or B) or with no prior anti-PD-1/PD-L1 therapy and failed standard of care treatment (phase 1b cohort C, D, or E).

Have received no more than 3 prior lines of systemic therapy for advanced disease.

Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.

Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan.

Have adequate organ function.

Exclusion Criteria:

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)

Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter prior to treatment.

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.

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.

Have known active CNS metastases and/or carcinomatous meningitis.

Participants with known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA.

Prolongation of corrected QT.

Significant cardiovascular impairment.

Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, or vomiting) that might impair the bioavailability of AN0025.

Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432857


Contacts
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Contact: Nathan Lautermilch, Ph.D. 1-848-230-7430 ext 414 Nathan.Lautermilch@adlainortye.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: David Hong, MD    713-563-5844    dshong@mdanderson.org   
United States, Utah
University of Utah School of Medicine Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Arun Athithan       Arun.Athithan@hci.utah.edu   
Contact: Susan Sharry       Susan.Sharry@hci.utah.edu   
Principal Investigator: Wallace Akerley, M.D.         
United States, Virginia
University of Virginia Recruiting
Richmond, Virginia, United States, 22908
Contact: Jennifer Drake, BSN, RN    434-297-7782      
Contact       JD4CX@hscmail.mcc.virginia.edu   
Principal Investigator: Matthew Reilley, M.D.         
France
Centre Léon Bérard Recruiting
Lyon, France
Contact: Marielle BOSSE-PLATIERE    33 (0)4 69 85 61 51    marielle.bosse-platiere@lyon.unicancer.fr   
Principal Investigator: Philippe Cassier, MD         
Gustave Roussy Recruiting
Paris, France, 94805
Contact: Assia HAMAMOUCHE    (+33) 1 42 11 56 54    assia.hamamouche@gustaveroussy.fr   
Principal Investigator: Aurélien Marabelle, M.D.         
Sponsors and Collaborators
Adlai Nortye Biopharma Co., Ltd.
Investigators
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Study Director: Nathan Lautermilch, Ph.D. ADLAI NORTYE USA INC.
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Responsible Party: Adlai Nortye Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04432857    
Other Study ID Numbers: AN0025S0103
2019-003960-37 ( EudraCT Number )
Keynote 879 ( Other Identifier: Merck )
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Urinary Bladder Neoplasms
Neoplasms by Site
Neoplasms
Urogenital Neoplasms
Breast Neoplasms
Breast Diseases
Skin Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents