NCT03215030 (iinnovate-1) is a Phase 1, PHASE2 clinical trial of Modakafusp alfa in Multiple Myeloma, sponsored by Teva Branded Pharmaceutical Products R&D LLC.

Who is sponsoring NCT03215030?

NCT03215030 is sponsored by Teva Branded Pharmaceutical Products R&D LLC.

What drugs are being tested in NCT03215030?

Interventions in NCT03215030: Modakafusp alfa, Dexamethasone.

What condition does NCT03215030 study?

NCT03215030 studies Multiple Myeloma.

Is NCT03215030 still recruiting?

NCT03215030 is currently terminated. Last updated 29 January 2026.

Are results published for NCT03215030?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-29 · How we verify

NCT03215030: iinnovate-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

Terminated Phase 1, PHASE2 Results posted Last updated 29 January 2026

What this trial tests

Phase 1, PHASE2 trial testing Modakafusp alfa in Multiple Myeloma in 272 participants. Terminated before completion.

Timeline

4 October 2017

Primary endpoint
1 July 2024

7 November 2024

Quick facts

Lead sponsor	Teva Branded Pharmaceutical Products R&D LLC
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	272
Start date	4 October 2017
Primary completion	1 July 2024
Estimated completion	7 November 2024
Sites	94 locations across France, Italy, Japan, Greece, Taiwan, United Kingdom, Germany, Israel

Drugs / interventions tested

Modakafusp alfa — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Teva Branded Pharmaceutical Products R&D LLC — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) Primary · Up to 54.3 months in Part 1

An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	100
Part 1 (Dose Escalation) Schedule B	100
Part 1 (Dose Escalation) Schedule C	100
Part 1 (Dose Escalation) Schedule D	100

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) Primary · Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)

DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	4
Part 1 (Dose Escalation) Schedule B	3
Part 1 (Dose Escalation) Schedule C	0
Part 1 (Dose Escalation) Schedule D	3

Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs Primary · Up to 54.3 months in Part 1

An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	95
Part 1 (Dose Escalation) Schedule B	100
Part 1 (Dose Escalation) Schedule C	85.7
Part 1 (Dose Escalation) Schedule D	95.2

Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs) Primary · Up to approximately 54.3 months in Part 1

AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug \& within 30 days of last administration of study drug. Serious

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	40
Part 1 (Dose Escalation) Schedule B	75
Part 1 (Dose Escalation) Schedule C	28.6
Part 1 (Dose Escalation) Schedule D	61.9

Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE Primary · Up to 54.3 months in Part 1

An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and w

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	15
Part 1 (Dose Escalation) Schedule B	25
Part 1 (Dose Escalation) Schedule C	0
Part 1 (Dose Escalation) Schedule D	14.3

Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay Primary · Up to 54.3 months in Part 1

Percentages were rounded off to the nearest decimal.

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	30
Part 1 (Dose Escalation) Schedule B	12.5
Part 1 (Dose Escalation) Schedule C	57.1
Part 1 (Dose Escalation) Schedule D	9.5

Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions Primary · Up to 54.3 months in Part 1

Percentages were rounded off to the nearest decimal.

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	15
Part 1 (Dose Escalation) Schedule B	0
Part 1 (Dose Escalation) Schedule C	0
Part 1 (Dose Escalation) Schedule D	0

Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions Primary · Up to 54.3 months in Part 1

Percentages were rounded off to the nearest decimal.

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	10
Part 1 (Dose Escalation) Schedule B	12.5
Part 1 (Dose Escalation) Schedule C	0
Part 1 (Dose Escalation) Schedule D	9.5

Part 2: Overall Response Rate (ORR) Primary · Up to 34.7 months in Part 2

ORR was defined as the percentage of participants who achieved a partial response (PR) rate or better (stringent complete response \[sCR\] + complete response \[CR\] + very good partial response \[VGPR\] + PR) during the study as defined by international myeloma working group (IMWG) uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal free light chain (FLC) rat

Group	Value	95% CI
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa	0	0.00 – 36.94
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone	0	0.00 – 70.76
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa	48	27.80 – 68.69
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone	32	14.95 – 53.50

Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events Secondary · Up to 54.3 months in Part 1; Up to 34.7 months in Part 2

Percentage of participants with TEAEs meeting DLT definition were reported. Toxicity was evaluated as per the NCI CTCAE, Version 5.0. The hematologic TEAEs of Grade ≥3 clearly unrelated to the underlying disease and occur during the first cycle that are considered DLTs: Grade ≥3 hemolysis; Grade 4 neutropenia for \>7 consecutive days; Grade 4 thrombocytopenia for \>14 consecutive days; Grade 3 thrombocytopenia with clinically significant bleeding; Any other Grade ≥4 hematologic toxicity except for Grade 4 lymphopenia. An incomplete recovery from treatment-related toxicity causing \>2-week dela

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A	10
Part 1 (Dose Escalation) Schedule B	0
Part 1 (Dose Escalation) Schedule C	0
Part 1 (Dose Escalation) Schedule D	9.5
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa	12.5
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone	66.7
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa	24
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone	25

Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa Secondary · Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)

As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.

Cycle 1 Day 1

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg	14.7	± 47.6
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg	154	± 95.5
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg	2980	± 29.0
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg	11800	± 33.5
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg	1260	± 106.1
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	2230	± 53.8
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg	2460	± 38.6
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg	15000	± 20.0
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg	11600	± 30.9
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg	15900	± 27.1

Cycle 1 Day 15

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg	16.9	± 75.4
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg	289	± 71.8
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg	2750	± 18.1
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg	11900	± 40.8
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg	1030	± 183.5
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	2600	± 37.9

Cycle 2 Day 1

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg	47.5	± 175.1
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg	158	± NA
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg	3030	± 10.1
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	1970	± NA
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg	2490	± 41.5
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg	15100	± 2.3
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg	9690	± 21.3
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg	16800	± 31.3

Cycle 2 Day 15

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg	1730	± NA
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	1270	± NA

Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa Secondary · Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)

As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.

Cycle 1 Day 1

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg	4.03	3.97 – 4.15
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg	3.99	1.95 – 4.25
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg	4.40	3.92 – 6.10
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg	4.27	4.00 – 6.28
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg	4.75	3.97 – 5.60
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	4.03	4.00 – 4.10
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg	4.78	3.87 – 6.05
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg	3.07	2.07 – 4.07
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg	4.94	4.00 – 6.02
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg	4.03	3.77 – 7.65

Cycle 1 Day 15

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg	3.93	2.02 – 4.05
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg	4.02	3.93 – 4.20
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg	4.25	4.08 – 4.35
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg	5.87	5.78 – 5.95
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg	4.28	4.15 – 6.17
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	4.00	4.00 – 4.10

Cycle 2 Day 1

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg	2.97	1.97 – 3.98
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg	4.23	4.23 – 4.23
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg	3.98	3.90 – 4.05
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	4.45	4.45 – 4.45
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg	4.00	3.90 – 5.92
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg	3.21	2.23 – 4.18
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg	4.13	3.90 – 5.95
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg	5.52	3.98 – 7.05

Cycle 2 Day 15

Group	Value	95% CI
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg	5.65	5.65 – 5.65
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg	4.00	4.00 – 4.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 (Dose Escalation) Schedule A

Serious: 8/20 (40%)

Deaths: 15/20

Part 1 (Dose Escalation) Schedule B

Serious: 6/8 (75%)

Deaths: 6/8

Part 1 (Dose Escalation) Schedule C

Serious: 2/7 (29%)

Deaths: 6/7

Part 1 (Dose Escalation) Schedule D

Serious: 13/21 (62%)

Deaths: 8/21

Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa

Serious: 1/8 (13%)

Deaths: 3/8

Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone

Serious: 1/3 (33%)

Deaths: 1/3

Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa

Serious: 7/25 (28%)

Deaths: 5/25

Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone

Serious: 9/25 (36%)

Deaths: 6/25

Part 3 (Dose Extension): Modakafusp Alfa 120 mg

Serious: 28/71 (39%)

Deaths: 19/71

Part 3 (Dose Extension): Modakafusp Alfa 240 mg

Serious: 33/75 (44%)

Deaths: 20/75

Japan Lead-in: Modakafusp Alfa 60 mg

Serious: 0/3 (0%)

Deaths: 0/3

Japan Lead-in: Modakafusp Alfa 120 mg

Serious: 0/2 (0%)

Deaths: 0/2

Serious adverse events (104 terms)

Reaction	System	Part 1 (Dose Escalation) S…	Part 1 (Dose Escalation) S…	Part 1 (Dose Escalation) S…	Part 1 (Dose Escalation) S…	Part 2 (Dose Expansion): S…	Part 2 (Dose Expansion): S…	Part 2 (Dose Expansion): S…	Part 2 (Dose Expansion): S…	Part 3 (Dose Extension): M…	Part 3 (Dose Extension): M…	Japan Lead-in: Modakafusp …	Japan Lead-in: Modakafusp …
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Encephalopathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Anal incontinence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Bacterial infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (150 terms — click to expand)

Reaction	System	Part 1 (Dose Escalation) S…	Part 1 (Dose Escalation) S…	Part 1 (Dose Escalation) S…	Part 1 (Dose Escalation) S…	Part 2 (Dose Expansion): S…	Part 2 (Dose Expansion): S…	Part 2 (Dose Expansion): S…	Part 2 (Dose Expansion): S…	Part 3 (Dose Extension): M…	Part 3 (Dose Extension): M…	Japan Lead-in: Modakafusp …	Japan Lead-in: Modakafusp …
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Acute kidney injury, Thrombocytopenia, Hypercalcaemia, Infusion related reaction, Respiratory tract infection, Anaemia, Asthenia.

Data from ClinicalTrials.gov NCT03215030 adverse events section.

Sponsor's own description

The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Engineering cytokine therapeutics.
Deckers J, Anbergen T, Hokke AM, de Dreu A, et al · · 2023 · cited 132× · PMID 37064653 · DOI 10.1038/s44222-023-00030-y
Next-generation cytokines for cancer immunotherapy.
Xue D, Hsu E, Fu YX, Peng H. · · 2021 · cited 59× · PMID 34263141 · DOI 10.1093/abt/tbab014
Multiple Myeloma Therapy: Emerging Trends and Challenges.
Dima D, Jiang D, Singh DJ, Hasipek M, et al · · 2022 · cited 51× · PMID 36077618 · DOI 10.3390/cancers14174082
Targeted Therapy With Immunoconjugates for Multiple Myeloma.
Bruins WSC, Zweegman S, Mutis T, van de Donk NWCJ. · · 2020 · cited 42× · PMID 32636838 · DOI 10.3389/fimmu.2020.01155
Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924
HLA Desensitization in Solid Organ Transplantation: Anti-CD38 to Across the Immunological Barriers.
Joher N, Matignon M, Grimbert P. · · 2021 · cited 31× · PMID 34093594 · DOI 10.3389/fimmu.2021.688301
Monoclonal Antibodies and Antibody Drug Conjugates in Multiple Myeloma.
Radocha J, van de Donk NWCJ, Weisel K. · · 2021 · cited 30× · PMID 33805481 · DOI 10.3390/cancers13071571
Myeloma: next generation immunotherapy.
Cohen AD. · · 2019 · cited 22× · PMID 31808859 · DOI 10.1182/hematology.2019000068

Verify or expand the search:

Other trials of Modakafusp alfa

Trials testing the same drug.

NCT05556616 — A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma · Phase 1 · terminated

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

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NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other Teva Branded Pharmaceutical Products R&D LLC trials

Trials by the same sponsor.

NCT07197866 — An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy · Phase 2 · recruiting
NCT06807463 — A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease · Phase 2 · active not recruiting
NCT06911567 — A Study to Assess New Formulations of TEV-56286 · Phase 1 · completed
NCT06625177 — A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo · Phase 1 · active not recruiting
NCT06568237 — A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03215030 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D LLC
Last refreshed: 29 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03215030.

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NCT03215030: iinnovate-1

Quick facts

Drugs / interventions tested

Conditions studied

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Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (104 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Modakafusp alfa

Other recruiting trials for Multiple Myeloma

Other Teva Branded Pharmaceutical Products R&D LLC trials

Verify against primary sources