Relapsed or Refractory Multiple MyelomaPhase 1NCT02675452

AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study testing AMG 176, Azacitidine and Itraconazole in people with Relapsed or Refractory Multiple Myeloma and Relapsed or Refractory Acute Myeloid Leukemia, run by Amgen at 24 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The main objectives are to evaluate the safety and tolerability of AMG 176 monotherapy in participants with relapsed or refractory multiple myeloma and participants with relapsed or refractory acute myeloid leukemia. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Relapsed or Refractory Multiple Myeloma, Relapsed or Refractory Acute Myeloid Leukemia
What is being tested?: AMG 176, Azacitidine and Itraconazole
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 24 sitesin 5 countries
Study dates: 13 Jun 2016to 27 May 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For participants in Japan only: if a participant is younger than 20 years at the time of signing the informed consent form, informed consent must be obtained from both the participant and his/her legal representative
(Multiple myeloma [MM] participants) Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy
(MM participants only) Measurable disease per the International Myeloma Working Group response criteria
(Acute myeloid leukemia [AML] participants) AML as defined by the World Health Organization Classification persisting or recurring following one or more treatment courses, and for participants in Japan, determined by the investigator to be not eligible for approved anticancer drug therapy in Japan; EXCEPT acute promyelocytic leukemia.
(AML participants only) More than 5% blasts in bone marrow and Circulating white blood cells < 25,000/ul.
Must be willing and able to undergo a core bone marrow biopsy (MM participants only) and bone marrow aspirate (MM and AML participants) at screening.

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Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2,
(MM partiicpants only) Satisfactory hematological function without transfusion or growth factor support
Life expectancy of > 3 months, in the opinion of the investigator
Adequate hepatic function
Adequate cardiac function
Adequate renal function
Female participants of childbearing potential must have a negative serum or urine pregnancy test
Other inclusion criteria may apply

Who cannot join

Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft-versus-host disease
Autologous stem cell transplant less than 90 days prior to study day 1
(MM participants only) MM with Immunoglobulin M subtype
(MM participants only) Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes syndrome
(MM participants only) Existing plasma cell leukemia
(MM participants only) Waldenstrom's macroglobulinemia

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(MM participants only) Amyloidosis
Infection requiring intravenous anti-infective treatments within 1 week of study enrollment (day 1)
Myocardial infarction within 6 months of enrollment, symptomatic congestive heart failure (New York Heart Association > class II)
History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6 months prior to enrollment
Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study will be allowed if approved by Amgen medical monitor
Participants with elevated cardiac troponin above the manufacturer's 99th percentile upper reference limit for ADVIA Centaur XP assay at screening performed by the central laboratory
Participants with evidence of recent cardiac injury at screening based on creatine kinase-muscle/brain, N-terminal prohormone of brain natriuretic peptide, and electrocardiogram
Other exclusion criteria may apply
(AML Part 3d only) History of QT prolongation, torsades de pointes, ventricular tachycardia and cardiac arrest
History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with medical monitor.

Trial locations and contacts

24 sites in 5 countries.

Country

City, postcode or hospital

24 sites in 5 countries

United States10 sites

Northside Hospital
Atlanta, Georgia, 30342
University of Colorado
Aurora, Colorado, 80045
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
University of Chicago Hospital
Chicago, Illinois, 60637
City of Hope National Medical Center
Duarte, California, 91010
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University Medical Center New Orleans
New Orleans, Louisiana, 70112
University of California Davis Medical Center
Sacramento, California, 95817
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Other trials in United States

Japan5 sites

National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625

Other trials in Japan

Germany4 sites

Universitaetsklinikum der Rheinisch-Westfaelischen Technischen Hochschule Aachen
Aachen, 52074
Universitaetsklinikum Bonn
Bonn, 53127
Universitaetsklinikum Ulm
Ulm, 89081
Universitaetsklinikum Wuerzburg
Würzburg, 97080

Other trials in Germany

Australia3 sites

The Alfred Hospital
Melbourne, Victoria, 3004
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal North Shore Hospital
St Leonards, New South Wales, 2065

Other trials in Australia

Canada2 sites

Tom Baker Cancer Centre
Calgary, Alberta, T2N 2T9
University Health Network-Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Read the detailed description

This is a Phase 1, first-in-human, multicenter; non-randomized, open-label and dose-exploration study of AMG 176 administered IV in participants with relapsed or refractory multiple myeloma and participants with relapsed or refractory acute myeloid leukemia The study will be conducted in five parts.

Conditions: Relapsed or Refractory Multiple Myeloma, Relapsed or Refractory Acute Myeloid Leukemia
Being tested: AMG 176, Azacitidine, Itraconazole
Medical subject headings: Recurrence, Multiple Myeloma, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 176Drug
Also called Study Investigational Product (IP)
Study Drug
AzacitidineDrug
Non-investigational product
ItraconazoleDrug
Non-investigational product

Study groups in NCT02675452
Study group	Role	What they receive
AMG 176 - Part 1a	Experimental	Part 1a - Participants with muliple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion for two-consecutive days (QD2) followed by a 5 days break. Receives: Drug: AMG 176
AMG 176 - Part 1b	Experimental	Part 1b - Participants with multiple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break. Receives: Drug: AMG 176
AMG 176 - Part 3a	Experimental	Part 3a - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion once a day, for two-consecutive days (QD2) followed by a 5 day break. Receives: Drug: AMG 176
AMG 176 - Part 3b	Experimental	Part 3b - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break. Receives: Drug: AMG 176
AMG 176 - Part 3c	Experimental	Part 3c - Participants in Japan only with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break. Receives: Drug: AMG 176
AMG 176 - Part 3d	Experimental	Part 3d - Participants in the United States with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW), for 3 weeks, in combination with itraconazole. Receives: Drug: AMG 176; Drug: Itraconazole
AMG 176 - Part 4	Experimental	Part 4 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine. Receives: Drug: AMG 176; Drug: Azacitidine
AMG 176 - Part 5	Experimental	Part 5 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion at the maximum tolerated combination dose from Part 4, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine. Receives: Drug: AMG 176; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
A DLT was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0, and considered by the investigators to be related to AMG 176. A DLT was defined as a grade 3 or higher non-hematological or a grade 4 hematologic adverse event (AE) that occurred during the DLT observation period.
CTCAE is graded from grade 1 to 5, with higher grades indicating a worse outcome, and included; grade 1 = mild, grade 2= moderate, grade 3 = severe, grade 4 = life-threatening, and grade 5 = death.
Measured: Days 1 to 28 of cycle 1 (4 weeks)
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a clinical trial participant.
A TEAE was an AE that started on or after the first dose of investigational product (AMG 176) up to 30 days after the end of investigational product. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests were reported as TEAEs.
A treatment-related AE was any TEAE that per investigator review had a reasonable possibility of being caused by the investigational product (AMG 176).
Measured: Day 1 cycle 1 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months
Maximum Observed Concentration (Cmax) of AMG 176
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (LLOQ) of 5.00 ng/mL were set to zero before data analysis.
Measured: Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, end of infusion (EOI), 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI
Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of AMG 176 (Parts 1A, 3A [Cohorts 1, 2, and 3], and 4 [Cohorts 5A and 5B])
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
Measured: Parts 1A, 3A and, 4: Cycle 1 day 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre and EOI
AUC From Time 0 to 144 Hours (AUC0-144) of AMG 176 (Parts 1A, 3A [Cohorts 1, 2, and 3], and 4 [Cohorts 5A and 5B])
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
Measured: Parts 1A, 3A, and 4: Cycle 1 day 2 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 9 pre and EOI
AUC From Time 0 to 168 Hours (AUC0-168) of AMG 176 (Parts 1B, 3 [Cohort 4], 3B, 3C, and 3D)
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
Measured: Parts 1B, 3B, 3C, and 3 (cohort 4): Cycle 1 day 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre, EOI; Part 3d also cycle 1 day 15 pre and EOI
Clearance (CL) of AMG 176
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis. Clearance was calculated as Dose/ AUC0-144 for Parts 1A, 3A, and 4; and as Dose/AUC0-168 for Parts 1B, 3 (Cohort 4 only) 3B, 3C, and 3D.
Measured: Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI
Terminal Half-life (t1/2) of AMG 176
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
Measured: Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI

Secondary outcomes (2)

Best Overall Response According to Revised International Working Group Uniform Response Criteria (IMWG-URC) for MM Participants (Parts 1A and 1B)
A response consisted of any of the following, assessed according to the IMWG-URC: stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-hrs). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hrs urinary M-protein by ≥ 90% or to < 200 mg/24-hours; MR: 25-49% reduction in serum M-protein and 50-89% reduction in 24-hr urinary M-protein (>200 mg/24-hrs); SD: not meeting criteria for CR, VGPR, PR, or PD; PD: ≥ 25% increase in serum or urine M-component, BM plasma cell percentages.
Measured: Day 1 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months
Best Overall Response According to the 2017 European LeukemiaNet (ELN) Criteria in AML Participants (Parts 3A, 3B, 3C, 3D, and 4)
A response was of any of the following, per the ELN criteria: Complete remission (CR) without minimal residual disease (CRMRD-), CR, CR with incomplete hematology recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR), SD, PD. CRMRD-: CR with negativity for genetic marker by quantitative reverse transcription (RT-qPCR) or multicolor flow cytometry (MFC); CR: BM blasts <5% bone marrow, no circulating blasts/ extramedullary disease, ANC > 1.0 x 10^9/L, platelets ≥ 100 x 10^9/L; CRi: CR except for neutropenia (< 1.0 x 10^9/L) or thrombocytopenia (< 100 x 10^9/L); MLFS: BM blasts < 5% no blasts with auer rods/extramedullary disease, no hematologic recovery; PR: hematological criteria of CR; decrease BM blast to 5-25%; decrease of BM blast percentage by ≤ 50%; SD: absence of CRMRD-, CR, CRi, PR, MLFS and criteria for PD not met; PD: evidence of increase in BM blast percentage and/or increase of absolute blast count.
Measured: Day 1 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201627 May 2024

First posted5 Feb 2016 (estimated)
Study start13 Jun 2016
Primary completion27 May 2024
Study completion27 May 2024

Why it stopped: sponsor decision, unrelated to safety

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02675452
Sponsor's protocol ID: 20150161
Other IDs: 2015-004777-32, 2015
Status last verified: Jun 2025
First submitted: 22 Dec 2015
Last updated: 9 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Multiple Myeloma, Refractory to Standard Treatment, Multiple Myeloma, Relapsed
RecruitingPhase 3
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Relapsed and/or Refractory Multiple Myeloma (RRMM)
Active, not recruitingObservational study
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
Relapsed/Refractory Multiple Myeloma

All Relapsed or Refractory Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT02675452
Acronym / sponsor ID: 20150161
Conditions: Relapsed or Refractory Multiple Myeloma, Relapsed or Refractory Acute Myeloid Leukemia
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: sponsor decision, unrelated to safety
Enrolment: 141 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 13 Jun 2016 (actual)
Primary completion: 27 May 2024 (actual)
Study completion: 27 May 2024 (actual)
First posted: 5 Feb 2016 (estimated)
Results: Posted 9 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
AMG 176 - Part 1a	Experimental	Drug: AMG 176Part 1a - Participants with muliple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion for two-consecutive days (QD2) followed by a 5 days break.
AMG 176 - Part 1b	Experimental	Drug: AMG 176Part 1b - Participants with multiple myeloma (MM) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
AMG 176 - Part 3a	Experimental	Drug: AMG 176Part 3a - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion once a day, for two-consecutive days (QD2) followed by a 5 day break.
AMG 176 - Part 3b	Experimental	Drug: AMG 176Part 3b - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
AMG 176 - Part 3c	Experimental	Drug: AMG 176Part 3c - Participants in Japan only with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW) followed by 6 days break.
AMG 176 - Part 3d	Experimental	Drug: AMG 176, Drug: ItraconazolePart 3d - Participants in the United States with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, once a week (QW), for 3 weeks, in combination with itraconazole.
AMG 176 - Part 4	Experimental	Drug: AMG 176, Drug: AzacitidinePart 4 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.
AMG 176 - Part 5	Experimental	Drug: AMG 176, Drug: AzacitidinePart 5 - Participants with acute myeloid leukemia (AML) administered AMG 176 as an intravenous (IV) infusion at the maximum tolerated combination dose from Part 4, either once a week (QW) followed by 6 days break, or once a day, for two-consecutive days (QD2), in combination with azacitidine.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

For participants in Japan only: if a participant is younger than 20 years at the time of signing the informed consent form, informed consent must be obtained from both the participant and his/her legal representative
(Multiple myeloma [MM] participants) Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy
(MM participants only) Measurable disease per the International Myeloma Working Group response criteria
(Acute myeloid leukemia [AML] participants) AML as defined by the World Health Organization Classification persisting or recurring following one or more treatment courses, and for participants in Japan, determined by the investigator to be not eligible for approved anticancer drug therapy in Japan; EXCEPT acute promyelocytic leukemia.
(AML participants only) More than 5% blasts in bone marrow and Circulating white blood cells < 25,000/ul.

Key exclusion criteria (16 listed)

Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft-versus-host disease
Autologous stem cell transplant less than 90 days prior to study day 1
(MM participants only) MM with Immunoglobulin M subtype
(MM participants only) Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes syndrome
(MM participants only) Existing plasma cell leukemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMG 176Also: Study Investigational Product (IP)Study Drug	Drug	AMG 176 - Part 1a, AMG 176 - Part 1b, AMG 176 - Part 3a, AMG 176 - Part 3b, AMG 176 - Part 3c, AMG 176 - Part 3d, AMG 176 - Part 4, AMG 176 - Part 5
AzacitidineNon-investigational product	Drug	AMG 176 - Part 4, AMG 176 - Part 5
ItraconazoleNon-investigational product	Drug	AMG 176 - Part 3d

Primary outcome

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Time frame: Days 1 to 28 of cycle 1 (4 weeks)
A DLT was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0, and considered by the investigators to be related to AMG 176. A DLT was defined as a grade 3 or higher non-hematological or a grade 4 hematologic adverse event (AE) that occurred during the DLT observation period. CTCAE is graded from grade 1 to 5, with higher grades indicating a worse outcome, and included; grade 1 = mild, grade 2= moderate, grade 3 = severe, grade 4 = life-threatening, and grade 5 = death.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 cycle 1 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months
An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (AMG 176) up to 30 days after the end of investigational product. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests were reported as TEAEs. A treatment-related AE was any TEAE that per investigator review had a reasonable possibility of being caused by the investigational product (AMG 176).
Maximum Observed Concentration (Cmax) of AMG 176
Time frame: Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, end of infusion (EOI), 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (LLOQ) of 5.00 ng/mL were set to zero before data analysis.
Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of AMG 176 (Parts 1A, 3A [Cohorts 1, 2, and 3], and 4 [Cohorts 5A and 5B])
Time frame: Parts 1A, 3A and, 4: Cycle 1 day 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre and EOI
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
AUC From Time 0 to 144 Hours (AUC0-144) of AMG 176 (Parts 1A, 3A [Cohorts 1, 2, and 3], and 4 [Cohorts 5A and 5B])
Time frame: Parts 1A, 3A, and 4: Cycle 1 day 2 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 9 pre and EOI
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
AUC From Time 0 to 168 Hours (AUC0-168) of AMG 176 (Parts 1B, 3 [Cohort 4], 3B, 3C, and 3D)
Time frame: Parts 1B, 3B, 3C, and 3 (cohort 4): Cycle 1 day 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre, EOI; Part 3d also cycle 1 day 15 pre and EOI
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
Clearance (CL) of AMG 176
Time frame: Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis. Clearance was calculated as Dose/ AUC0-144 for Parts 1A, 3A, and 4; and as Dose/AUC0-168 for Parts 1B, 3 (Cohort 4 only) 3B, 3C, and 3D.
Terminal Half-life (t1/2) of AMG 176
Time frame: Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.

2 secondary outcomes

Best Overall Response According to Revised International Working Group Uniform Response Criteria (IMWG-URC) for MM Participants (Parts 1A and 1B)
Time frame: Day 1 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months
Best Overall Response According to the 2017 European LeukemiaNet (ELN) Criteria in AML Participants (Parts 3A, 3B, 3C, 3D, and 4)
Time frame: Day 1 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months

Results and safety

Results posted to the registry on 9 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1A Cohort 1 (MM): AMG 176 Dose A Twice Weekly (BIW)	3	3
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW	3	2
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW	4	3
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW	3	3
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW	3	3
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW	2	1
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW	4	4
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW	4	4
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW	5	4
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW	5	3
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F Once Weekly (QW)	3	3
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW	3	2
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW	3	1
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW	3	0
Part 3A Cohort 1 (AML): AMG 176 Dose D BIW	6	4
Part 3A Cohort 2 (AML): AMG 176 Dose E BIW	5	3
Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW	5	2
Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW	2	2
Part 3B Cohort 1 (AML): AMG 176 Dose E QW	4	0
Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW	3	0
Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW	4	1
Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW	4	1
Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole	10	0
Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine	5	0
Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine	5	1
Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine	4	0
Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine	13	1
Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine	10	1
Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine	13	0

Primary outcome: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

Time frame: Days 1 to 28 of cycle 1 (4 weeks). Count of participants. Unit: Participants

Measure	Part 1A Cohort 1 (MM): AMG 176 Dose A BIW n = 3	Part 1A Cohort 2 (MM): AMG 176 Dose B BIW n = 3	Part 1A Cohort 3 (MM): AMG 176 Dose C BIW n = 4	Part 1A Cohort 4 (MM): AMG 176 Dose D BIW n = 3	Part 1A Cohort 5 (MM): AMG 176 Dose E BIW n = 3	Part 1A Cohort 6 (MM): AMG 176 Dose G BIW n = 2	Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW n = 4	Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW n = 4	Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW n = 5	Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW n = 5	Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW n = 3	Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW n = 3	Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW n = 3	Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW n = 3	Part 3A Cohort 1 (AML): AMG 176 Dose D BIW n = 5	Part 3A Cohort 2 (AML): AMG 176 Dose E BIW n = 5	Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW n = 5	Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW n = 2	Part 3B Cohort 1 (AML): AMG 176 Dose E QW n = 4	Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW n = 3	Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW n = 4	Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW n = 4	Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole

Primary outcome: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Time frame: Day 1 cycle 1 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months. Count of participants. Unit: Participants

Measure	Part 1A Cohort 1 (MM): AMG 176 Dose A BIW n = 3	Part 1A Cohort 2 (MM): AMG 176 Dose B BIW n = 3	Part 1A Cohort 3 (MM): AMG 176 Dose C BIW n = 4	Part 1A Cohort 4 (MM): AMG 176 Dose D BIW n = 3	Part 1A Cohort 5 (MM): AMG 176 Dose E BIW n = 3	Part 1A Cohort 6 (MM): AMG 176 Dose G BIW n = 2	Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW n = 4	Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW n = 4	Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW n = 5	Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW n = 5	Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW n = 3	Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW n = 3	Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW n = 3	Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW n = 3	Part 3A Cohort 1 (AML): AMG 176 Dose D BIW n = 5	Part 3A Cohort 2 (AML): AMG 176 Dose E BIW n = 5	Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW n = 5	Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW n = 2	Part 3B Cohort 1 (AML): AMG 176 Dose E QW n = 4	Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW n = 3	Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW n = 4	Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW n = 4	Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole

Primary outcome: Maximum Observed Concentration (Cmax) of AMG 176

Time frame: Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, end of infusion (EOI), 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI. Median (Full Range). Unit: ng/mL

Measure	Part 1A Cohort 1 (MM): AMG 176 Dose A BIW n = 3	Part 1A Cohort 2 (MM): AMG 176 Dose B BIW n = 3	Part 1A Cohort 3 (MM): AMG 176 Dose C BIW n = 4	Part 1A Cohort 4 (MM): AMG 176 Dose D BIW n = 3	Part 1A Cohort 5 (MM): AMG 176 Dose E BIW n = 3	Part 1A Cohort 6 (MM): AMG 176 Dose G BIW n = 2	Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW n = 3	Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW n = 4	Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW n = 5	Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW n = 5	Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW n = 3	Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW n = 3	Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW n = 2	Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW n = 3	Part 3A Cohort 1 (AML): AMG 176 Dose D BIW n = 5	Part 3A Cohort 2 (AML): AMG 176 Dose E BIW n = 5	Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW n = 5	Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW n = 2	Part 3B Cohort 1 (AML): AMG 176 Dose E QW n = 4	Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW n = 3	Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW n = 4	Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW

Primary outcome: Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of AMG 176 (Parts 1A, 3A [Cohorts 1, 2, and 3], and 4 [Cohorts 5A and 5B])

Time frame: Parts 1A, 3A and, 4: Cycle 1 day 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre and EOI. Median (Full Range). Unit: hour*ng/mL

Measure	Part 1A Cohort 1 (MM): AMG 176 Dose A BIW n = 3	Part 1A Cohort 2 (MM): AMG 176 Dose B BIW n = 3	Part 1A Cohort 3 (MM): AMG 176 Dose C BIW n = 4	Part 1A Cohort 4 (MM): AMG 176 Dose D BIW n = 3	Part 1A Cohort 5 (MM): AMG 176 Dose E BIW n = 3	Part 1A Cohort 6 (MM): AMG 176 Dose G BIW n = 2	Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW n = 3	Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW n = 4	Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW n = 3	Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW n = 2	Part 3 Cohort 1 (AML): AMG 176 Dose D BIW n = 5	Part 3 Cohort 2 (AML): AMG 176 Dose E BIW n = 5	Part 3 Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW n = 3	Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine n = 3	Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine n = 6
Cycle 1 day 1	6230 (6100 to 11500)	13700 (11900 to 16500)	13900 (3570 to 18700)	32700 (21300 to 44100)	48500 (36700 to 60900)	–	26700 (11000 to 42400)	128000 (40100 to 216000)	47700 (38500 to 56800)	38500 (24100 to 52800)	18300 (10000 to 28900)	44700 (17100 to 66100)	64900 (35900 to 83900)	30100 (26300 to 50200)	32000 (22000 to 37100)
Cycle 1 day 8	–	–	21100 (21100 to 21100)	3240 (3240 to 3240)	130000 (130000 to 130000)	–	52300 (20600 to 84000)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: For mortality, from enrolment to end of study; median time on study was 2.3 months. For AEs, from first dose of AMG 176 to 30 days after the last dose of AMG 176; median treatment duration was 1.2 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW	2 of 2 (100%)	1 of 2 (50%)	1 of 2
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW	3 of 4 (75%)	4 of 4 (100%)	0 of 4
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW	2 of 5 (40%)	5 of 5 (100%)	1 of 5
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW	3 of 5 (60%)	5 of 5 (100%)	0 of 5
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part 3A Cohort 1 (AML): AMG 176 Dose D BIW	3 of 5 (60%)	4 of 5 (80%)	0 of 5
Part 3A Cohort 2 (AML): AMG 176 Dose E BIW	4 of 5 (80%)	3 of 5 (60%)

Limitations and caveats (from the sponsor): The study was conducted in multiple parts and Part 5 did not enroll any participants due to early termination of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

24 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Japan, Germany, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) (time frame: Days 1 to 28 of cycle 1 (4 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02675452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.

Cycle 1 day 1	2270 (1980 to 3690)	2900 (1730 to 4340)	3590 (1490 to 4310)	5790 (4420 to 7160)	10100 (9640 to 19000)	26100 (25500 to 26700)	10100 (7490 to 14200)	24700 (3180 to 46200)	4880 (3580 to 5920)	5440 (3950 to 8590)	7940 (7010 to 9760)	6450 (6390 to 7460)	12100 (3080 to 21100)	4590 (4130 to 5050)	5140 (3000 to 11900)	5570 (3260 to 13800)	6250 (4010 to 30800)	7790 (7400 to 8180)	3600 (2850 to 5880)	5230 (3070 to 5360)	3270 (0.00 to 5510)	6290 (5900 to 7210)	1670 (0.00 to 2400)	–	–	–	–	5500 (0.00 to 21900)	5380 (0.00 to 10700)
Cycle 1 day 2	1780 (1490 to 4080)	3800 (2340 to 5420)	3570 (1290 to 4910)	8270 (7020 to 9520)	11800 (11200 to 12900)	27300 (27300 to 27300)	6500 (2890 to 8400)	7980 (6770 to 42600)	5230 (0.00 to 16600)	7670 (4590 to 32000)	–	–	–	–	6280 (2760 to 16100)	7250 (4620 to 21600)	6910 (4340 to 128000)	–	–	–	–	–	–	–	–	–	–	4200 (0.00 to 23500)	7050 (3440 to 143000)
Cycle 1 day 8	1740 (1140 to 2930)	3830 (1660 to 4510)	3250 (1590 to 4840)	5650 (3910 to 6470)	10200 (9740 to 11300)	39400 (39400 to 39400)	17700 (10300 to 25000)	18400 (10600 to 80300)	18700 (14700 to 22200)	31900 (28500 to 35300)	16100 (10600 to 26700)	15000 (13800 to 17200)	23800 (23800 to 23800)	37600 (26700 to 41900)	5580 (2660 to 12200)	8500 (6570 to 27200)	12700 (7140 to 187000)	12200 (11400 to 12900)	3770 (2520 to 5420)	6300 (28.6 to 21300)	11100 (0.00 to 15100)	6020 (5730 to 8610)	1850 (1230 to 18900)	–	–	–	–	4710 (0.00 to 13500)	12700 (0.00 to 311000)
Cycle 1 day 9	2810 (34.7 to 4070)	3830 (2010 to 6780)	4480 (824 to 7130)	6400 (6010 to 7230)	11400 (11000 to 14100)	27300 (27300 to 27300)	15900 (13700 to 29400)	91100 (91100 to 91100)	19800 (11900 to 22900)	21100 (7030 to 21600)	–	–	–	–	9530 (2700 to 10800)	8670 (6490 to 10800)	12100 (7230 to 34900)	–	–	–	–	–	–	–	–	–	–	6880 (1850 to 26700)	14300 (40.1 to 52600)
Cycle 1 day 15	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	–	2140 (838 to 29300)	–	–	–	–	–	–

TEAEs	3	2	4	3	3	2	4	4	5	5	3	3	3	3	5	5	5	2	4	3	4	4	10	5	4	4	13	10	13
Treatment-related TEAEs	2	1	3	3	3	2	3	2	5	5	3	3	3	3	3	3	4	2	2	3	2	3	5	5	4	4	11	8	8