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BRIEF TITLE: Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

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


  • Org Study ID: AN0025S0103
  • Secondary ID: 2019-003960-37,Keynote 879
  • NCT ID: NCT04432857
  • NCT Alias:
  • Sponsor: Adlai Nortye Biopharma Co., Ltd. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting June 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Primary Outcome Measure

Primary Outcome 1 - Time Frame: 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

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jin Jin, 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
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting David Hong, MD
713-563-5844
dshong@mdanderson.org