TAK-573 for Multiple Myeloma

Phase-Based Progress Estimates

Effectiveness

Safety

Multiple MyelomaTAK-573 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial will test the safety and efficacy of modakafusp alfa in people with relapsed or refractory multiple myeloma.

Eligible Conditions

Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

RO7425781

Group 3 (RRMM Triplets) Arm C: Modakafusp alfa + Daratumumab + Carfilzomib

Cevostamab

Study Objectives

20 Primary · 57 Secondary · Reporting Duration: Up to 1 year

Day 28

Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa

Day 28

AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-573

AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for TAK-573

CL: Clearance for TAK-573

Cmax: Maximum Observed Serum Concentration for TAK-573

Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa

Part 1: CL: Clearance for Modakafusp alfa

Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa

Part 1: T1/2: Terminal Elimination Half-life for Modakafusp alfa

Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa

Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa

Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa

T1/2: Terminal Elimination Half-life for TAK-573

Tmax: Time to Reach the Cmax for TAK-573

Vss: Volume of Distribution at Steady State for TAK-573

λz: Terminal Disposition Rate Constant for TAK-573

Up to 1 year

Percentage of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

Phase 1- Clinical Benefit Rate (CBR)

Phase 1- DOR

Phase 1- Disease Control Rate (DCR)

Phase 1- ORR

Phase 1- PFS

Phase 1- Percentage of Participants Reporting one or More TEAEs, Serious Adverse Events, >=Grade 3 TEAEs, Dose Modification, Adverse Events Leading to Discontinuation of Study Drug, Clinically Significant Laboratory Values and Vital Signs

Phase 1- Time to Response

Phase 2- Clinical Benefit Rate (CBR)

Phase 2- Disease Control Rate (DCR)

Phase 2- Duration of Response (DOR)

Phase 2- Overall Response Rate (ORR)

Phase 2- Percentage of Participants Reporting one or More TEAEs, Dose Modification, Leading to Discontinuation of Study Drug, DLT-like, Clinically Significant Laboratory Values and Vital Signs

Phase 2- Progression-free Survival (PFS)

Phase 2- Time to Response

Day 28

Mutagenicity Tests

Phase 1- Percentage of Participants With Dose-limiting Toxicities (DLTs)

Month 90

Part 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events

Part 1: Objective Response Rate (ORR)

Part 1: Percentage of Participants Reporting one or More Grade 3 TEAEs

Part 1: Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)

Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

Part 1: Percentage of Participants Who Discontinue the Treatment Because of TEAE

Part 1: Percentage of Participants With Clinically Significant Laboratory Values

Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements

Part 1: Percentage of Participants With Dose Modifications: Dose Delay

Part 1: Percentage of Participants With Dose Modifications: Dose Interruptions

Part 1: Percentage of Participants With Dose Modifications: Dose Reductions

Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa

Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa

Part 2: CL: Clearance for Modakafusp alfa

Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa

Part 2: Overall Response Rate (ORR)

Part 2: T1/2z: Terminal Elimination Half-life for Modakafusp alfa

Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa

Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa

Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa

Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment

Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment

Part 3: Duration of Clinical Benefit

Part 3: Duration of Disease Control

Part 3: Health Care Utilization: Length of Hospital Stays

Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter

Part 3: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Status

Part 3: Objective Response Rate (ORR) by Investigator Assessment

Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)

Part 3: Patient-reported Outcome (PRO): Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)

Part 3: Percentage of Participants With Adverse Events (AEs)

Part 3: Percentage of Participants With Clinically Significant Laboratory Values

Part 3: Percentage of Participants With Neutralizing Antibodies (NAb)

Part 3: Percentage of Participants With Serious Adverse Events (SAEs)

Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

Part 3: Time to Progression (TTP) by IRC and Investigator Assessment

Part 3:Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

Parts 1 and 2: Clinical Benefit Rate (CBR)

Parts 1 and 2: Disease Control Rate (DCR)

Parts 1 and 2: Time to Response

Parts 1, 2 and 3: Duration of Response (DOR)

Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibodies (ADA)

Parts 1, 2 and 3: Progression Free Survival (PFS)

Parts 2 and 3: Overall Survival (OS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

RO7425781

Group 3 (RRMM Triplets) Arm C: Modakafusp alfa + Daratumumab + Carfilzomib

Cevostamab

Trial Design

12 Treatment Groups

Phase 2: TAK-573 TBD

1 of 12

Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg

1 of 12

Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD

1 of 12

Phase 1 Schedule B: TAK-573 TBD

1 of 12

Phase 1 Schedule A: TAK-573 0.001 to 14 mg/kg

1 of 12

Phase 1 Schedule C: TAK-573 TBD

1 of 12

Phase 1 Schedule D: TAK-573 TBD

1 of 12

Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD

1 of 12

Part 3 (Dose Extension): Modakafusp alfa 120 mg

1 of 12

Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD

1 of 12

Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg

1 of 12

Part 3 (Dose Extension): Modakafusp alfa 240 mg

1 of 12

Experimental Treatment

336 Total Participants · 12 Treatment Groups

Primary Treatment: TAK-573 · No Placebo Group · Phase 1 & 2

Phase 2: TAK-573 TBDExperimental Group · 2 Interventions: TAK-573, Dexamethasone · Intervention Types: Drug, Drug

Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg

Drug

Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug

Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD

Drug

Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug

Phase 1 Schedule B: TAK-573 TBD

Drug

Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug

Phase 1 Schedule A: TAK-573 0.001 to 14 mg/kg

Drug

Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug

Phase 1 Schedule C: TAK-573 TBD

Drug

Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug

Phase 1 Schedule D: TAK-573 TBD

Drug

Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug

Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD

Drug

Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug

Part 3 (Dose Extension): Modakafusp alfa 120 mg

Drug

Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug

Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD

Drug

Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug

Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mgExperimental Group · 2 Interventions: Modakafusp alfa, Dexamethasone · Intervention Types: Drug, Drug

Part 3 (Dose Extension): Modakafusp alfa 240 mg

Drug

Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: up to 1 year

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor

404 Previous Clinical Trials

51,697 Total Patients Enrolled

82 Trials studying Multiple Myeloma

9,654 Patients Enrolled for Multiple Myeloma

TakedaLead Sponsor

1,116 Previous Clinical Trials

4,053,794 Total Patients Enrolled

45 Trials studying Multiple Myeloma

16,879 Patients Enrolled for Multiple Myeloma

Medical Director Clinical ScienceStudy DirectorMillennium Pharmaceuticals, Inc.

195 Previous Clinical Trials

62,896 Total Patients Enrolled

8 Trials studying Multiple Myeloma

2,351 Patients Enrolled for Multiple Myeloma

Study DirectorStudy DirectorTakeda

1,068 Previous Clinical Trials

475,063 Total Patients Enrolled

22 Trials studying Multiple Myeloma

3,860 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

You are refractory to or intolerant of at least 1 PI and a least 1 IMiD.

You have a serum M-protein level of 500 mg/dL (5 g/L) or higher.

You have myeloma and need additional therapy.

You have received at least 3 lines of myeloma therapy.

You have a performance status of ≤2.

References

2017. "A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03215030.

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TAK-573 for Multiple Myeloma

Study Summary

Treatment Effectiveness

Effectiveness Progress

Similar Trials

Study Objectives

Trial Safety

Safety Progress

Similar Trials

Trial Design

12 Treatment Groups

Phase 2: TAK-573 TBD

1 of 12

Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg

1 of 12

Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD

1 of 12

Phase 1 Schedule B: TAK-573 TBD

1 of 12

Phase 1 Schedule A: TAK-573 0.001 to 14 mg/kg

1 of 12

Phase 1 Schedule C: TAK-573 TBD

1 of 12

Phase 1 Schedule D: TAK-573 TBD

1 of 12

Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD

1 of 12

Part 3 (Dose Extension): Modakafusp alfa 120 mg

1 of 12

Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD

1 of 12

Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg

1 of 12

Part 3 (Dose Extension): Modakafusp alfa 240 mg

1 of 12

Trial Logistics

Trial Timeline

Who is running the clinical trial?

Eligibility Criteria

Other Trials to Consider

RO7425781for Multiple Myeloma

Group 3 (RRMM Triplets) Arm C: Modakafusp Alfa + Daratumumab + Carfilzomibfor Multiple Myeloma

Cevostamabfor Multiple Myeloma

NMS-03597812for Multiple Myeloma

Dose Escalationfor Multiple Myeloma

TNB-383Bfor Multiple Myeloma

HPN217for Multiple Myeloma

CC-92480for Multiple Myeloma

Phase 1 Dose Escalationfor Multiple Myeloma

Main Cohort: TAK-341 Dose 2for Multiple System Atrophy

INBRX-109for Chondrosarcoma

JNJ-68284528for Multiple Myeloma

Daratumumab Injectionfor Multiple Myeloma

Magrolimabfor Multiple Myeloma

Selinexorfor Multiple Myeloma

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