TerminatedNCT01874288DI-Leu16-IL2Updated Nov 24, 2020Results posted

A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL

A Phase 1/2 interventional study of DI-Leu16-IL2 in B-cell Non-Hodgkin Lymphoma, sponsored by Alopexx Oncology, LLC. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Alopexx Oncology, LLC · Phase 1/2, Interventional, and Treatment

Why this study was terminated

Clinical benefit was noted in the earlier portion of the trial; hence, participants were not enrolled in 2 expansion cohorts and the study was terminated early.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This dose-escalation study is designed for determining the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 (CD20) positive NHL that have failed standard rituximab-containing therapy.

Read the detailed description

The participants will be enrolled during dose escalation and during 2 expansion cohorts of up to 12 participants each.

The dose escalation portion of the trial will incorporate a modified accelerated titration design. Therefore, the trial will enroll 3 participants per dose level with a doubling of the dose at each level during the accelerated stage of the study (skipping every other dose level). Once the first instance of any Grade 3 or higher treatment related toxicity (with some notable exceptions) is observed on the first cycle, the accelerated stage will end and the trial will revert to a conventional design using cohorts of 3 or 6 participants (standard 3+3 design), with single step 2 milligrams (mg)/square meter (m\^2) increments.

To further explore the clinical efficacy, additional participants (up to 12 per cohort) may be enrolled at the optimal biologic dose (OBD) or maximum tolerated dose (MTD).

At the end of the study, participants may be enrolled into an open-label extension study (AO-101-EXT [NCT02151903]), at the discretion of the investigator.

Conditions studied

B-cell Non-Hodgkin Lymphoma

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Keywords

NHL
Immunocytokine
Lymphoma
Non-Hodgkin
B-cell
IL (interleukin)

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Alopexx Oncology, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

Who can participate

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

Inclusion criteria

Participants with CD20-expressing B-cell NHL that is relapsed or refractory to standard therapy. Chronic lymphocytic leukemia/small lymphocytic lymphoma with peripheral blood leukemia/lymphoma cells and high-grade lymphomas are excluded.
Participants must have received prior rituximab-containing therapy.
Evaluable disease. In the absence of lymphadenopathy, splenomegaly with defects or measurable extra-medullary disease is acceptable.
Participants who have received a prior autologous stem cell transplant are eligible if the transplant occurred >6 months ago.
Participants who have received a prior allogeneic stem cell transplant are eligible if:
1. The transplant occurred >6 months ago
2. There is no evidence of active graft versus host disease
3. Systemic immunosuppressive agents (including corticosteroids) have not been received for at least 8 weeks
Karnofsky performance scale ≥70%
Life expectancy ≥12 weeks
Adequate baseline functions:
1. Serum creatinine ≤1.5 mg/deciliter (dL)
2. Total white blood cell (WBC) count ≥3000/microliter (µL) or absolute neutrophil count (ANC) ≥1000/µL
3. Absolute lymphocyte count ≥0.75 * 10\^3/µL
4. Platelet count ≥75,000/µL
5. Hematocrit ≥25% or hemoglobin ≥9 grams/100 milliliters (mL)
6. Alanine aminotransferase (ALT) \<2.5 * upper limit of normal (ULN)
7. Aspartate aminotransferase (AST) \<2.5 * ULN
8. Total bilirubin (TBili) \<1.5 * ULN
9. Sodium, potassium, and phosphorus levels no worse than grade 1
10. Chest x-ray (CXR) or computed tomography (CT) within 4 weeks prior to Day 1 with no evidence of pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema. If results are questionable, participants should have additional lung function testing to exclude clinically relevant restriction or obstruction. Participants must have a forced expiratory volume (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO) of at least 65% and 50% of expected, respectively.
11. Electrocardiogram (12-lead ECG) QTc ≤480 millisecond (ms)
12. Cardiac stress test (for example, stress thallium scan, stress echocardiography) with normal results if participant is suspected to have coronary artery disease.
Participants participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months).
Provide written informed consent prior to any screening procedures

Exclusion criteria

Exclusion Criteria:

Evidence of central nervous system lymphoma or lymphomatous meningitis
Prior treatment with interleukin 2 (IL2) within the last 5 years
Type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusion of rituximab
Pregnant or lactating female
An immediate need for palliative radiotherapy or systemic corticosteroid therapy
Known intercurrent infections (including hepatitis C virus and human immunodeficiency virus or other conditions), or clinical evidence of these conditions
Actively infected with or chronic carriers of hepatitis B virus as demonstrated by positive hepatitis B core antibody or hepatitis B surface antigen. Participants who are seropositive only, that is, surface antibody positive [HbsAb], are permitted.
Other significant active infection.
Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
Uncontrolled hypertension (diastolic greater to or equal to 100 millimeters of mercury [mmHg]) or hypotension (systolic less than or equal to 90 mmHg)
History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other significant arrhythmias
History of medically significant ascites requiring repetitive paracentesis
Previous diagnosis of autoimmune disease (Exceptions: participants with autoimmune thyroiditis or vitiligo may be enrolled)
Organ transplant recipient
History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study
Known hypersensitivity to Tween-80 or human immunoglobulin
Legal incapacity or limited legal capacity
Participants with bulky lymph nodes (LNs) (≥10 centimeters [cm]) or marked splenomegaly (that is, extending into pelvis or crossing the midline).
Circulating levels of rituximab >75.0 micrograms (µg)/mL

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
DI-Leu16-IL2 0.5 mg/m^2
Participants will receive DI-Leu16-IL2 0.5 mg/m\^2 subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
Drug: DI-Leu16-IL2
Experimental
DI-Leu16-IL2 1.0 mg/m^2
Participants will receive DI-Leu16-IL2 1.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
Drug: DI-Leu16-IL2
Experimental
DI-Leu16-IL2 2.0 mg/m^2
Participants will receive DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
Drug: DI-Leu16-IL2
Experimental
DI-Leu16-IL2 4.0 mg/m^2
Participants will receive DI-Leu16-IL2 4.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles
Drug: DI-Leu16-IL2
Experimental
DI-Leu16-IL2 6.0 mg/m^2
Participants will receive DI-Leu16-IL2 6.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle) for a total of 4 cycles.
Drug: DI-Leu16-IL2

Interventions

DrugDI-Leu16-IL2
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.

What researchers measure

Primary outcomes

Maximum Tolerated Dose (MTD) of DI-Leu16-IL2
The MTD was determined based on toxicities from the first 2 cycles of treatment. The MTD was the highest dose tested with no more than 1 participant out of 6 experienced a dose-limiting toxicity (DLT). All non-hematologic adverse events (AEs) and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included absolute lymphocyte count (ALC) Grade 3 and 4 (if ALC does not resolve to baseline grade according to Common Terminology Criteria for Adverse Events (CTCAE) v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and absolute neutrophil count (ANC) Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Time frame: First 2 cycles of treatment (each cycle = 21 days)
Number of Participants With a DLT
All non-hematologic AEs and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included ALC Grade 3 and 4 (if ALC does not resolve to baseline grade according to CTCAE v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and ANC Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).
Time frame: First 2 cycles of treatment (each cycle = 21 days)
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1) Disappearance of all detectable clinical and radiological evidence of disease; 2) lymph nodes (LN) regressed to normal size; 3) other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4) clear bone marrow (BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass \>1.5 cm in greatest transverse diameter; individual nodes that were previously confluent regressed by \>75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion.
Time frame: First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 6 months)
Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study
Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m\^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
Time frame: Baseline, end of study (EOS) (up to approximately 3 years)
Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study
Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m\^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.
Time frame: Baseline, EOS (up to approximately 3 years)

Secondary outcomes

Number of Participants With Anti-DI-Leu16-IL2 Antibodies
Time frame: First dose of study drug up to EOS (up to approximately 3 years)

Results

Posted Nov 24, 2020

Limitations and caveats

Clinical benefit was noted in the earlier portion of the trial; hence, participants were not enrolled in 2 expansion cohorts and the study was terminated early.

Participant flow

Participant flow — Overall Study
Milestone	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2
Started	3	3	9	7	2
Received at least 1 dose of study drug	3	3	9	7	2
Completed	0	3	4	0	0
Not completed	3	0	5	7	2
Withdrew: Withdrawal by subject	1	0	2	1	1
Withdrew: Physician decision	0	0	0	1	0
Withdrew: Progressive disease	2	0	3	5	1

Outcome measures

PrimaryMaximum Tolerated Dose (MTD) of DI-Leu16-IL2

The MTD was determined based on toxicities from the first 2 cycles of treatment. The MTD was the highest dose tested with no more than 1 participant out of 6 experienced a dose-limiting toxicity (DLT). All non-hematologic adverse events (AEs) and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included absolute lymphocyte count (ALC) Grade 3 and 4 (if ALC does not resolve to baseline grade according to Common Terminology Criteria for Adverse Events (CTCAE) v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and absolute neutrophil count (ANC) Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).

Time frame:: First 2 cycles of treatment (each cycle = 21 days)
Reported as:: Number · mg/m^2

Maximum Tolerated Dose (MTD) of DI-Leu16-IL2
mg/m^2	DI-Leu16-IL2
Maximum Tolerated Dose (MTD) of DI-Leu16-IL2	4.0

PrimaryNumber of Participants With a DLT

All non-hematologic AEs and all hematologic AEs of greater than Grade 3 were considered relevant to determining DLTs. DLTs included ALC Grade 3 and 4 (if ALC does not resolve to baseline grade according to CTCAE v4 within 5 days post the final injection per cycle of DI-Leu16-IL2), and ANC Grade 3 (If ANC does not resolve to at least Grade 2 within 5 days post the final injection per cycle of DI-Leu16-IL2) and Grade 4 (any).

Time frame:: First 2 cycles of treatment (each cycle = 21 days)
Reported as:: Count of participants · Participants

Number of Participants With a DLT
Participants	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2
Number of Participants With a DLT	0	0	0	0	2

PrimaryNumber of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria

BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1) Disappearance of all detectable clinical and radiological evidence of disease; 2) lymph nodes (LN) regressed to normal size; 3) other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4) clear bone marrow (BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass \>1.5 cm in greatest transverse diameter; individual nodes that were previously confluent regressed by \>75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion.

Time frame:: First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 6 months)
Reported as:: Count of participants · Participants

Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
Participants	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2
CR	0	0	2	1	0
CRu	0	0	0	0	0
PR	0	1	1	0	0
SD	2	2	1	2	0
PD	1	0	4	4	2

PrimaryTumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study

Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m\^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.

Time frame:: Baseline, end of study (EOS) (up to approximately 3 years)
Reported as:: Mean · percent change

Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study
percent change	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2
Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study	—	-31.54881 ± 60.445273	-26.37248 ± 78.719865	48.83017 ± 120.291120	87.98408 ± 78.864919

PrimaryTumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study

Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection. None of the participants were considered evaluable in 'DI-Leu16-IL2 0.5 mg/m\^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm.

Time frame:: Baseline, EOS (up to approximately 3 years)
Reported as:: Mean · percent change

Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study
percent change	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2
Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study	—	-30.657 ± 60.3132	-27.412 ± 49.2553	1.398 ± 43.4731	28.516 ± 22.5263

SecondaryNumber of Participants With Anti-DI-Leu16-IL2 Antibodies

Time frame:: First dose of study drug up to EOS (up to approximately 3 years)

No measurements were reported for this outcome.

Adverse events

Collected over First dose of study drug up to EOS (up to approximately 3 years). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DI-Leu16-IL2 0.5 mg/m^2	0/3 (0%)	0/3 (0%)	3/3 (100%)
DI-Leu16-IL2 1.0 mg/m^2	0/3 (0%)	2/3 (66.7%)	3/3 (100%)
DI-Leu16-IL2 2.0 mg/m^2	0/9 (0%)	1/9 (11.1%)	9/9 (100%)
DI-Leu16-IL2 4.0 mg/m^2	0/7 (0%)	3/7 (42.9%)	7/7 (100%)
DI-Leu16-IL2 6.0 mg/m^2	0/2 (0%)	1/2 (50%)	2/2 (100%)

Most frequent serious events

Most frequent serious events
Event	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2
Cytokine release syndromeImmune system disorders	0/3	0/3	0/9	0/7	1/2
AnaemiaBlood and lymphatic system disorders	0/3	1/3	0/9	0/7	0/2
MelaenaGastrointestinal disorders	0/3	1/3	0/9	0/7	0/2
Abdominal infectionInfections and infestations	0/3	1/3	0/9	0/7	0/2
PyrexiaGeneral disorders	0/3	0/3	0/9	2/7	0/2
ThrombocytopeniaBlood and lymphatic system disorders	0/3	0/3	0/9	1/7	0/2
Renal failure acuteRenal and urinary disorders	0/3	0/3	0/9	1/7	0/2
DyspnoeaRespiratory, thoracic and mediastinal disorders	0/3	0/3	1/9	0/7	0/2

Most frequent other events

Showing 10 of 200

Most frequent other events
Event	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2
Injection site erythemaGeneral disorders	2/3	3/3	7/9	6/7	2/2
Injection site pruritusGeneral disorders	3/3	3/3	6/9	4/7	1/2
ChillsGeneral disorders	1/3	1/3	5/9	7/7	2/2
FatigueGeneral disorders	1/3	3/3	4/9	6/7	1/2
PyrexiaGeneral disorders	1/3	1/3	5/9	3/7	2/2
PainGeneral disorders	0/3	3/3	2/9	3/7	1/2
ThrombocytopeniaBlood and lymphatic system disorders	0/3	1/3	3/9	1/7	2/2
Alanine aminotransferase increasedInvestigations	0/3	0/3	2/9	1/7	2/2
Blood alkaline phosphatase increasedInvestigations	0/3	0/3	2/9	1/7	2/2
CoughRespiratory, thoracic and mediastinal disorders	1/3	2/3	1/9	1/7	2/2

Baseline characteristics

Safety population included all enrolled participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2	Total
Mean	51.3 ± 12.22	66.7 ± 14.84	64.0 ± 11.55	59.6 ± 9.61	57.5 ± 13.44	60.9 ± 11.49

Sex: Female, Male
Sex: Female, Male(Participants)	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2	Total
Female	1	1	6	0	2	10
Male	2	2	3	7	0	14

Tumor Measurement: Sum of Product of Diameters
Tumor Measurement: Sum of Product of Diameters(centimeters (cm))	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2	Total
Mean	15.11667 ± 9.726296	12.21667 ± 12.110806	17.63953 ± 16.388997	27.95857 ± 22.005858	27.86500 ± 10.896515	20.50816 ± 16.836733

Tumor Measurement: Sum of Longest of Diameters
Tumor Measurement: Sum of Longest of Diameters(cm)	DI-Leu16-IL2 0.5 mg/m^2	DI-Leu16-IL2 1.0 mg/m^2	DI-Leu16-IL2 2.0 mg/m^2	DI-Leu16-IL2 4.0 mg/m^2	DI-Leu16-IL2 6.0 mg/m^2	Total
Mean	6.000 ± 3.0414	6.133 ± 4.3524	9.462 ± 5.4068	11.100 ± 5.1901	10.300 ± 5.6569	9.161 ± 4.9829

Study locations

5 sites

City of Hope
Duarte, California 91010, United States
St. Jude Hospital Yorba Linda
Fullerton, California 92835, United States
University of Minnesota
Minneapolis, Minnesota 55455, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States
Joe Arlington Cancer Research and Treatment Center
Lubbock, Texas 97410, United States

References and documents

Publications

King DM, Albertini MR, Schalch H, Hank JA, Gan J, Surfus J, Mahvi D, Schiller JH, Warner T, Kim K, Eickhoff J, Kendra K, Reisfeld R, Gillies SD, Sondel P. Phase I clinical trial of the immunocytokine EMD 273063 in melanoma patients. J Clin Oncol. 2004 Nov 15;22(22):4463-73. doi: 10.1200/JCO.2004.11.035. Epub 2004 Oct 13. PubMed 15483010 ↗
Ko YJ, Bubley GJ, Weber R, Redfern C, Gold DP, Finke L, Kovar A, Dahl T, Gillies SD. Safety, pharmacokinetics, and biological pharmacodynamics of the immunocytokine EMD 273066 (huKS-IL2): results of a phase I trial in patients with prostate cancer. J Immunother. 2004 May-Jun;27(3):232-9. doi: 10.1097/00002371-200405000-00008. PubMed 15076141 ↗
Maloney DG, Liles TM, Czerwinski DK, Waldichuk C, Rosenberg J, Grillo-Lopez A, Levy R. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood. 1994 Oct 15;84(8):2457-66. PubMed 7522629 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01874288
Lead sponsor: Alopexx Oncology, LLC
Responsible party: Sponsor
First posted: Jun 11, 2013
Start date: Nov 25, 2013
Primary completion: Jan 27, 2014
Completion: Nov 16, 2016
Results posted: Nov 24, 2020
Last update: Nov 24, 2020

Study contacts

Daniel Vlock, MD

study director · Alopexx Oncology, LLC

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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