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 : February 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 |
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.
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Drug: AN0025
oral administration
Other Name: E7046 Drug: Pembrolizumab Infusion
Other Names:
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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:
|
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:
|
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:
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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:
|
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:
|
- Primary Outcome Measure [ Time Frame: 3 weeks ]Number of participants with Dose Limiting Toxicities (DLTs)
- ORR and Progression-Free Survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: 2 years ]
- Duration of Response (DOR) [ Time Frame: 2 years ]
- Overall Survival (OS) [ Time Frame: 2 years ]
- Efficacy by PD-L1 expression [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Robert Atkinson, Ph.D. | 1-919741-8894 | Robert.Atkinson@adlainortye.com |
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. |
Study Director: | Robert Atkinson, Ph.D. | Adlai Nortye US Inc |
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 Sharpe & Dohme Corp. ) MK3475-879 ( Other Identifier: Merck Sharpe & Dohme Corp. ) |
First Posted: | June 16, 2020 Key Record Dates |
Last Update Posted: | February 17, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |