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

INTRODUCTION

  • Org Study ID: AN0025S0103
  • Secondary ID: 2019-003960-37, Keynote 879
  • NTC ID: NCT04432857
  • Sponsor: 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.

  • Overall Status
    Recruiting
  • Start Date
    August 20, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Primary Outcome Measure

Primary Outcome 1 - Timeframe: 3 weeks

CONDITION

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

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nathan Lautermilch, Ph.D.

Role: Study Director

Affiliation: ADLAI NORTYE USA INC.

Overall Contact

Name: Nathan Lautermilch, Ph.D.

Phone: 1-848-230-7430

Email: Nathan.Lautermilch@adlainortye.com

LOCATION

Facility Status Contact
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
David Hong, MD
713-563-5844
dshong@mdanderson.org
Facility: University of Utah School of Medicine Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Arun Athithan
434-297-7782
Arun.Athithan@hci.utah.edu
Facility: University of Virginia
Richmond, Virginia 22908
United States
Status: Recruiting Contact: Contact
Susan Sharry
33 (0)4 69 85 61 51
Susan.Sharry@hci.utah.edu
Facility: Centre Léon Bérard
Lyon, 94805
France
Status: Recruiting Contact: Principal Investigator
Wallace Akerley, M.D.
(+33) 1 42 11 56 54
JD4CX@hscmail.mcc.virginia.edu
Facility: Gustave Roussy
Paris,
France
Status: Recruiting Contact: Contact
Jennifer Drake, BSN, RN

marielle.bosse-platiere@lyon.unicancer.fr