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NCT02988817 · REGISTRY CONDITION SEARCH

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2023-08-01

The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part

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outcome · POSTED

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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outcome · POSTED

Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin

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outcome · POSTED

Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03

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outcome · POSTED

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part

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outcome · POSTED

Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part

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outcome · POSTED

Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part

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outcome · POSTED

Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part

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outcome · POSTED

Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part

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outcome · POSTED

Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part

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outcome · POSTED

Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part

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outcome · POSTED

AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part

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outcome · POSTED

AUC0-last of MMAE for 1Q3W Dose-escalation Part

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outcome · POSTED

Cmax of MMAE for Dose-escalation Part

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outcome · POSTED

Total CL of MMAE in Dose-escalation Part

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outcome · POSTED

Tmax of MMAE for Dose-escalation Part

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outcome · POSTED

t1/2 of MMAE for Dose-escalation Part

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outcome · POSTED

Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin

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outcome · POSTED

Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator

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outcome · POSTED

Number of Participants With Best Cancer Antigen 125 (CA-125) Response

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outcome · POSTED

Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part

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outcome · POSTED

Progression Free Survival (PFS) as Assessed by Investigator

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part

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outcome · POSTED

Number of Participants With Grade 3 or 4 Laboratory Results

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. For the dose escalation part: Patients with selected, relapsed or refractory solid tumors who have failed available standard therapy or who are not candidates for standard therapy. For the expansion part: Patients with advanced and/or metastatic solid tumors who are not candidates for standard therapy 2. Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST). 3. For the expansion patients must provide a tumor tissue sample from archival tissue or fresh biopsy at enrolment 4. Age ≥ 18 years. 5. Acceptable renal function 6. Acceptable liver function 7. Acceptable hematological status 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 9. Life expectancy of at least three months. 10. Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last infusion of HuMax-AXL-ADC 11. Patients must provide a signed informed consent form before any trial relates activities are carried out. Exclusion Criteria: 1. Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 4 weeks prior to first IMP administration. 2. Have clinically significant cardiac disease 3. Known congestive heart failure and/ or a known decreased cardiac ejection fraction of \< 45%. A baseline QT interval as corrected by Fridericia's formula (QTcF) \> 480 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block. 4. Uncontrolled hypertension 5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first IMP administration. 6. Have received a cumulative dose of corticosteroid \> 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first Investigational Medicinal Product (IMP) administration. 7. History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial. 8. Major surgery within four weeks before first IMP administration. 9. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke. 10. Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within five half-lives but maximum four weeks before first infusion. Accepted exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist. 11. Prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. 12. Radiotherapy within 14 days prior to first IMP administration. 13. Known past or current malignancy other than inclusion diagnosis, except for: * Cervical carcinoma of Stage 1B or less. * Non-invasive basal cell or squamous cell skin carcinoma. * Non-invasive, superficial bladder cancer. * Prostate cancer with a current prostate specific antigen (PSA) level \< 0.1 ng/mL. * Breast cancer in BRCA1 or BRCA2 positive ovarian cancer patients. * Any curable cancer with a complete response (CR) of \> 2 years duration. 14. Melanoma patients with an lactate dehydrogenase (LDH) ≥ 3 x upper limit normal (ULN). 15. Ongoing significant, uncontrolled medical condition including: o Serious, non-healing wound, skin ulcer (of any grade), or bone fracture. 16. Grade 2 or higher peripheral neuropathy. 17. Clinically significant active viral, bacterial or fungal infection 18. Known human immunodeficiency virus seropositivity. 19. Known positive serology for hepatitis B (unless due to vaccination or passive immunization due to immunoglobulin therapy) 20. Known positive serology for hepatitis C (unless due to immunoglobulin therapy) 21. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result 22. History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of IMP 23. Body weight \< 40 kg 24. Women who are pregnant or breast feeding. 25. Pulmonary hemorrhage or hemoptysis \> 2.5 ml blood within 6 weeks unless cause has been addressed and is medically resolved. 26. History of acute pneumonitis.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants in all cohorts of the trial (both in escalation and expansion phase) will be administered enapotamab vedotin (HuMax-AXL-ADC) intravenously (IV).
    intervention Names
    1. Biological: Enapotamab vedotin (HuMax-AXL-ADC)
    label
    Enapotamab vedotin (HuMax-AXL-ADC)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Enapotamab vedotin (HuMax-AXL-ADC)
    description
    Enapotamab vedotin (HuMax-AXL-ADC) will be administered intravenously.
    name
    Enapotamab vedotin (HuMax-AXL-ADC)
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
306
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any \>=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).
    measure
    Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part
    time Frame
    From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen
  2. description
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received.
    measure
    Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    time Frame
    Day 1 through Day 1130 (maximum observed duration)
  3. description
    Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.
    measure
    Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin
    time Frame
    Day 1 through Day 1130 (maximum observed duration)
  4. description
    Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.
    measure
    Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
    time Frame
    Day 1 through Day 1130 (maximum observed duration)
  5. description
    Number of participants with laboratory measurements graded as Grade 3 or 4 by NCI-CTCAE v 4.03 is reported.
    measure
    Number of Participants With Grade 3 or 4 Laboratory Results
    time Frame
    Day 1 through Day 1130 (maximum observed duration)
secondary Outcomes
  1. description
    The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
    measure
    Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
    time Frame
    Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
  2. description
    The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
    measure
    Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
    time Frame
    Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
  3. description
    The Cmax of conjugated enapotamab vedotin for dose-escalation part is reported.
    measure
    Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
  4. description
    The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.
    measure
    Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
  5. description
    The Tmax of conjugated enapotamab vedotin for dose-escalation part is reported.
    measure
    Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
  6. description
    The t1/2 of conjugated enapotamab vedotin for dose-escalation part is reported.
    measure
    Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
  7. description
    The Vss of conjugated enapotamab vedotin for dose-escalation part is reported.
    measure
    Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
  8. description
    The AUC0-inf of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
    measure
    AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part
    time Frame
    Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
  9. description
    The AUC0-last of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
    measure
    AUC0-last of MMAE for 1Q3W Dose-escalation Part
    time Frame
    Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
  10. description
    The Cmax of MMAE for dose-escalation part is reported.
    measure
    Cmax of MMAE for Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
  11. description
    The total CL of MMAE in dose-escalation part is reported.
    measure
    Total CL of MMAE in Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
  12. description
    The Tmax of MMAE for dose-escalation part is reported.
    measure
    Tmax of MMAE for Dose-escalation Part
    time Frame
    For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Full study description
brief Summary
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
detailed Description
The trial consists of two parts; a dose escalation part (phase I, first in-human (FIH)) and an expansion part (phase IIa). The dose escalation part has 2 dosing schedules: 1 dose every 3 weeks (1Q3W) dose regimen, and 3 doses every 4 weeks (3Q4W) dosing regimen. The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice