Trial Outcomes & Findings for ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN (NCT NCT04639024)
NCT ID: NCT04639024
Last Updated: 2026-05-01
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
up to 12 weeks after the last dose (up to 7 months in total)
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
ADCT-301 Infusion
Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
ADCT-301: Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
|
|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN
Baseline characteristics by cohort
| Measure |
ADCT-301 Infusion
n=3 Participants
Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
ADCT-301: Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
|
|---|---|
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Age, Continuous
|
63.7 years
STANDARD_DEVIATION 9.1 • n=14 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: duration of study, up to approximately 11 monthsPopulation: 1 subject received 2 cycles of study medication and was evaluated for response. They had refractory disease.
Participants were considered evaluable for efficacy if they were eligible and received at least one dose of the study agent and 2 cycles of therapy unless they withdraw early for safety.
Outcome measures
| Measure |
ADCT-301 Infusion
n=1 Participants
Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
ADCT-301: Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
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|---|---|
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Number of Participants With Complete Remission (CR) or Complete Remission With Incomplete Count Recovery (CRi)
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0 Participants
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PRIMARY outcome
Timeframe: up to 12 weeks after the last dose (up to 7 months in total)Outcome measures
| Measure |
ADCT-301 Infusion
n=3 Participants
Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
ADCT-301: Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
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|---|---|
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Safety of ADCT-301 as Measured by Number of Participants With Unacceptable (Dose Limiting) Toxicities
|
1 Participants
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Adverse Events
ADCT-301 Infusion
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ADCT-301 Infusion
n=3 participants at risk
Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
ADCT-301: Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • up to 12 weeks after the last dose (up to 7 months in total)
An AE can be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to use of the study drug. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs. But laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • up to 12 weeks after the last dose (up to 7 months in total)
An AE can be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to use of the study drug. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs. But laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
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Other adverse events
| Measure |
ADCT-301 Infusion
n=3 participants at risk
Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
ADCT-301: Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
|
|---|---|
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Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • up to 12 weeks after the last dose (up to 7 months in total)
An AE can be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to use of the study drug. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs. But laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
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Vascular disorders
Capillary leak syndrome
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33.3%
1/3 • up to 12 weeks after the last dose (up to 7 months in total)
An AE can be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to use of the study drug. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs. But laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place