CClinicalTrials.gg
Sign In
TerminatedNCT02864290Updated Oct 23, 2024

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

A Phase 1 interventional study of ASP1235 in Acute Myeloid Leukemia, sponsored by Astellas Pharma Global Development, Inc.. Terminated at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.

Sponsored by Astellas Pharma Global Development, Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
Study was terminated due to lack of efficacy.

From the registry’s dates

  • Primary completion was Sep 2020, 6 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and tolerability of ASP1235 (AGS62P1) given at three dosing schedules (Schedule A, every three weeks [Q3W] or Schedule B, every other week of a 4 week cycle [Q2W] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the anti-leukemic activity of ASP1235 (AGS62P1).

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • AML
  • Pharmacokinetics of ASP1235 (AGS62P1)
  • ASP1235
  • Acute Myeloid Leukemia
  • ASP1235 (AGS62P1)
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's enrollment of 43 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject has morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) which is relapsed or refractory after failing at least 1 regimen and is not a candidate for established salvage treatment regimens. For expansion cohorts, patients are eligible if they have had ≤ 3 prior lines of therapy. Lines of therapy include initial induction (up to 2 cycles) with consolidation/maintenance, if applicable, and subsequent salvage regimens. Consolidation alone and stem cell transplantation are not counted as lines of therapy.
  • Subject has an Eastern Cooperative Oncology Group performance score (ECOG) ≤ 2
  • Subject has adequate renal function with an estimated creatinine clearance of ≥ 30 mL/min by the Cockcroft-Gault equation adjusted for body weight
  • Subject has a total bilirubin ≤ 1.5 x upper limit of normal (ULN), albumin ≥ 2.5 g/d, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Subjects must be competent to comprehend, provide written informed consent, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form

  • A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:

    • Not a woman of childbearing potential (WOCBP) OR
    • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
  • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
  • A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
  • A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration.
  • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.

Exclusion criteria

Exclusion Criteria:

  • Subject has a diagnosis of acute promyelocytic leukemia (APL)
  • Subject has preexisting sensory or motor neuropathy Grade ≥ 2 at baseline
  • Subject has received small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, investigational drug, or chemotherapy within 14 days before first dose of study drug, with the exception of hydroxyurea
  • Subject has any Grade ≥ 2 persistent non-hematological toxicity related to allotransplant

  • Subject with Graft vs. Host Disease (GVHD) who is receiving treatment with systemic glucocorticoids > 10 mg/day equivalent of prednisone; however, treatment with low dose glucocorticoids (≤ 10 mg/day equivalent of prednisone) is permitted

    • The use of systemic glucocorticoids in excess of 10 mg/day equivalent of prednisone is permitted provided it is not for the treatment of GVHD (e.g. chronic obstructive pulmonary disease, anti-emetic, infusion reactions). The chronic use of topical, inhaled, and locally injected steroids is permitted
  • Subject has known current central nervous system (CNS) disease
  • Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of the first dose of study drug, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by medication
  • Subject has clinical evidence of Disseminated Intravascular Coagulation
  • Subject has known positivity for human immunodeficiency virus
  • Subject has known active hepatitis B (positive hepatitis B surface antigen [HBs Ag]) or C infection. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible.
  • Subject has an uncontrolled active infection requiring treatment and grade 3 or higher fever 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy) are allowed provided the subject has a temperature of \< 38.3°C within 48 hours of the first dose of study drug.

  • Subject has a known sensitivity to any of the components of the investigational product ASP1235 (AGS62P1):

    • ASP1235 (AGS62P1)
    • L-Histidine base
    • L-Histidine HCl
    • α, α -Trehalose Dihydrate
    • Polysorbate 20
  • Major surgery within 28 days of the first dose of study drug
  • Subject is pregnant or lactating
  • Subject has a condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
  • Subject has any medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures

  • Subject has ocular condition such as:

    • Active infection or corneal ulcer
    • Monocularity
    • History of corneal transplantation
    • Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
    • Uncontrolled glaucoma (topical medications allowed)
    • Uncontrolled or active ocular problems (e.g., retinopathy, macular edema, active uveitis, macular degeneration) requiring surgery, laser treatment, or intravitreal injections
    • Papilledema or other active optic nerve disorder
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Dose Escalation of ASP1235 (AGS62P1) Schedule A

    Subjects will receive ASP1235 (AGS62P1) as an intravenous infusion once every three weeks (Q3W) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose. A cycle is 21 days.

    Drug: ASP1235

  • Experimental
    Dose Escalation of ASP1235 (AGS62P1) Schedule B

    Subjects will receive ASP1235 (AGS62P1) as an intravenous infusion every other week of a 4-week cycle (Q2W) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose. A cycle is 28 days.

    Drug: ASP1235

  • Experimental
    Dose Expansion of ASP1235 (AGS62P1) Schedule A

    Once the maximum tolerated dose (MTD) or recommended Phase 2 dose has been determined, an expansion cohort of up to 25 subjects may be enrolled. Subjects will receive ASP1235 (AGS62P1) as an intravenous infusion once every three weeks (Q3W).

    Drug: ASP1235

  • Experimental
    Dose Expansion of ASP1235 (AGS62P1) Schedule B

    Once the maximum tolerated dose (MTD) or recommended Phase 2 dose has been determined, an expansion cohort of up to 25 subjects may be enrolled. Subjects will receive ASP1235 (AGS62P1) as an intravenous infusion every other week of a 4-week cycle (Q2W).

    Drug: ASP1235

  • Experimental
    Dose Escalation of ASP1235 (AGS62P1) Schedule C

    Subjects will receive ASP1235 (AGS62P1) as an intravenous infusion once weekly for three weeks of a 4-week cycle to determine the MTD or recommended Phase 2 dose. A cycle is 28 days.

    Drug: ASP1235

  • Experimental
    Dose Expansion of ASP1235 (AGS62P1) Schedule C

    Once the MTD or recommended Phase 2 dose has been determined, an expansion cohort of up to 25 subjects may be enrolled. Subjects will receive ASP1235 (AGS62P1) as an intravenous infusion once weekly for three weeks pf a 4-week cycle.

    Drug: ASP1235

Interventions

  • DrugASP1235

    intravenous (IV) infusion

    Also known as: AGS62P1

06

What researchers measure

Primary outcomes

  1. Incidence and nature of adverse events

    AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) grading scale, version 4.03 (National Institutes of Health, 2010).

    Time frame: up to 30 months

Secondary outcomes

  1. Incidence of antidrug antibody (ADA) formation to the fully human monoclonal antibody (AGS62P) and antibody-conjugate (ASP1235 [AGS62P1])

    Time frame: up to 46 months

  2. Complete response (CR)

    Time frame: up to 46 months

  3. Composite complete remission (CRc) rate

    Time frame: up to 46 months

  4. Best response rate

    Time frame: up to 46 months

  5. Duration of remission

    Time frame: up to 46 months

  6. Duration of response

    Time frame: up to 46 months

  7. Morphologic leukemia free state (MLFS) rate

    Time frame: up to 30 months

  8. Concentration at the end of infusion (CEOI) of total antibody (TAb) in dose escalation part

    Time frame: up to an average of 30 months

  9. Concentration at the end of infusion (CEOI) of antibody drug conjugate (ADC) in dose escalation part

    Time frame: up to an average of 30 months

  10. Concentration at the end of infusion (CEOI) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part

    Time frame: up to an average of 30 months

  11. Maximum observed concentration (Cmax) of total antibody (TAb) in dose escalation part

    Time frame: up to an average of 30 months

  12. Maximum observed concentration (Cmax) of antibody drug conjugate (ADC) in dose escalation part

    Time frame: up to an average of 30 months

  13. Maximum observed concentration (Cmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part

    Time frame: up to an average of 30 months

  14. Time to maximum concentration (Tmax) of total antibody (TAb) in dose escalation part

    Time frame: up to an average of 30 months

  15. Time to maximum concentration (Tmax) of antibody drug conjugate (ADC) in dose escalation part

    Time frame: up to an average of 30 months

  16. Time to maximum concentration (Tmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part

    Time frame: up to an average of 30 months

  17. Partial area under the serum concentration-time curve (AUC) of total antibody (TAb) in dose escalation part

    Time frame: up to an average of 30 months

  18. Partial area under the serum concentration-time curve (AUC) of antibody drug conjugate (ADC) in dose escalation part

    Time frame: up to an average of 30 months

  19. Partial area under the serum concentration-time curve (AUC) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part

    Time frame: up to an average of 30 months

  20. Terminal or apparent terminal half-life (t1/2) of total antibody (TAb) in dose escalation part

    Time frame: up to an average of 30 months

  21. Terminal or apparent terminal half-life (t1/2) of antibody drug conjugate (ADC) in dose escalation part

    Time frame: up to an average of 30 months

  22. Terminal or apparent terminal half-life (t1/2) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part

    Time frame: up to an average of 30 months

  23. Systemic clearance (CL) of total antibody (TAb) in dose escalation part

    Time frame: up to an average of 30 months

  24. Systemic clearance (CL) of antibody drug conjugate (ADC) in dose escalation part

    Time frame: up to an average of 30 months

  25. Systemic clearance (CL) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part

    Time frame: up to an average of 30 months

  26. Volume of distribution at steady state (Vss) of total antibody (TAb) in dose escalation part

    Time frame: up to an average of 30 months

  27. Volume of distribution at steady state (Vss) of antibody drug conjugate (ADC) in dose escalation part

    Time frame: up to an average of 30 months

  28. Volume of distribution at steady state (Vss) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose escalation part

    Time frame: up to an average of 30 months

  29. Concentration at the end of infusion (CEOI) of total antibody (TAb) in dose expansion part

    Time frame: up to an average of 30 months

  30. Concentration at the end of infusion (CEOI) of antibody drug conjugate (ADC) in dose expansion part

    Time frame: up to an average of 30 months

  31. Concentration at the end of infusion (CEOI) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part

    Time frame: up to an average of 30 months

  32. Maximum observed concentration (Cmax) of total antibody (TAb) in dose expansion part

    Time frame: up to an average of 30 months

  33. Maximum observed concentration (Cmax) of antibody drug conjugate (ADC) in dose expansion part

    Time frame: up to an average of 30 months

  34. Maximum observed concentration (Cmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part

    Time frame: up to an average of 30 months

  35. Time to maximum concentration (Tmax) of total antibody (TAb) in dose expansion part

    Time frame: up to an average of 30 months

  36. Time to maximum concentration (Tmax) of antibody drug conjugate (ADC) in dose expansion part

    Time frame: up to an average of 30 months

  37. Time to maximum concentration (Tmax) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part

    Time frame: up to an average of 30 months

  38. Partial area under the serum concentration-time curve (AUC) of total antibody (TAb) in dose expansion part

    Time frame: up to an average of 30 months

  39. Partial area under the serum concentration-time curve (AUC) of antibody drug conjugate (ADC) in dose expansion part

    Time frame: up to an average of 30 months

  40. Partial area under the serum concentration-time curve (AUC) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part

    Time frame: up to an average of 30 months

  41. Terminal or apparent terminal half-life (t1/2) of total antibody (TAb) in dose expansion part

    Time frame: up to an average of 30 months

  42. Terminal or apparent terminal half-life (t1/2) of antibody drug conjugate (ADC) in dose expansion part

    Time frame: up to an average of 30 months

  43. Terminal or apparent terminal half-life (t1/2) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part

    Time frame: up to an average of 30 months

  44. Systemic clearance (CL) of total antibody (TAb) in dose expansion part

    Time frame: up to an average of 30 months

  45. Systemic clearance (CL) of antibody drug conjugate (ADC) in dose expansion part

    Time frame: up to an average of 30 months

  46. Systemic clearance (CL) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part

    Time frame: up to an average of 30 months

  47. Volume of distribution at steady state (Vss) of total antibody (TAb) in dose expansion part

    Time frame: up to an average of 30 months

  48. Volume of distribution at steady state (Vss) of antibody drug conjugate (ADC) in dose expansion part

    Time frame: up to an average of 30 months

  49. Volume of distribution at steady state (Vss) of metabolite para-acetyl phenylalanine attached to the microtubule disrupting agent linked to linker 30 (pAF-AGL-0185-30) in dose expansion part

    Time frame: up to an average of 30 months

07

Study locations

7 sites
  • Site US00006
    Duarte, California 91010, United States
  • Site US00003
    Baltimore, Maryland 21287, United States
  • Site US00007
    Boston, Massachusetts 02114, United States
  • Site US00009
    Boston, Massachusetts 02114, United States
  • Site US00004
    New York, New York 10016, United States
  • Site US00001
    Houston, Texas 77030, United States
  • Site CA00010
    Toronto, Ontario M5G 2M9, Canada
08

References and documents

Individual participant data

Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02864290
Lead sponsor
Astellas Pharma Global Development, Inc.
Responsible party
Sponsor
First posted
Aug 12, 2016
Start date
Nov 10, 2016
Primary completion
Sep 3, 2020
Completion
Sep 3, 2020
Last update
Oct 23, 2024

Study contacts

Associate Medical Officer
study director · Astellas Pharma Global Development, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

Astellas Pharma Global Development, Inc.

Start the discussion