Trial Outcomes & Findings for Sym004 Versus Futuximab or Modotuximab in Patients With mCRC (NCT NCT03549338)
NCT ID: NCT03549338
Last Updated: 2020-09-28
Results Overview
Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 5) (CTCAE v5). AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology and the severity of the toxicities will be graded according to the CTCAE v5, where applicable.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
4 months
Results posted on
2020-09-28
Participant Flow
The intended number of patients to be included in this trial was approximately 54 (18 evaluable per Arm). As of the trial termination date, 2 patients were enrolled.
The first patient was randomized to Arm B prior to the trial termination date and crossed over to Sym004 at the EOC1. The second patient was randomized to Arm B after the trial termination date, but enrolled to Arm A per Sponsor decision.
Participant milestones
| Measure |
Arm A (Sym004)
Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8.
For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover.
|
Arm B (Futuximab)
Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
|
Arm C (Modotuximab)
Modotuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the EOC2, ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of PD.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Sym004)
Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8.
For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover.
|
Arm B (Futuximab)
Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
|
Arm C (Modotuximab)
Modotuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the EOC2, ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of PD.
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
0
|
0
|
|
Overall Study
Clinical Progression
|
0
|
1
|
0
|
Baseline Characteristics
Sym004 Versus Futuximab or Modotuximab in Patients With mCRC
Baseline characteristics by cohort
| Measure |
Arm A (Sym004)
n=1 Participants
Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1/Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8.
|
Arm B (Futuximab)
n=1 Participants
Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will be crossed-over to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD). Sym004 will be given at the dose level that contains the corresponding dose level of the individual antibody futuximab prior to crossover.
|
Arm C (Modotuximab)
Modotuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the EOC2, ongoing patients will be crossed-over to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of PD. Sym004 will be given at the dose level that contains the corresponding dose level of the individual antibody modotuximab prior to crossover.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
—
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The first patient was randomized to Arm B prior to the trial termination date and crossed over to Sym004 at the EOC1. The second patient was randomized to Arm B after the trial termination date, but enrolled to Arm A per Sponsor decision.
Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 5) (CTCAE v5). AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology and the severity of the toxicities will be graded according to the CTCAE v5, where applicable.
Outcome measures
| Measure |
Arm A (Sym004)
n=2 Participants
Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8.
For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover.
|
Arm B (Futuximab)
n=1 Participants
Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.
At least one AE
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.
At least one SAE
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.
At least one AE related to Sym004
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.
At least one AE related to futuximab
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.
At least one SAE related to Sym004
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.
At least one SAE related to futuximab
|
0 participants
|
0 participants
|
Adverse Events
Arm A (Sym004)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B (Futuximab)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Sym004)
n=2 participants at risk
Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8. For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover.
|
Arm B (Futuximab)
n=1 participants at risk
Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
Other adverse events
| Measure |
Arm A (Sym004)
n=2 participants at risk
Sym004 will be given as a loading dose of 9 mg/kg on Cycle 1 Day 1 (C1D1), followed by weekly doses of 6 mg/kg beginning C1D8. For patients that crossover from Arm B and Arm C, Sym004 will be given at the dose level that contains the corresponding dose level of the respective individual antibody (futuximab or modotuximab) prior to crossover.
|
Arm B (Futuximab)
n=1 participants at risk
Futuximab will be given as a loading dose of 4.5 mg/kg on C1D1, followed by weekly doses of 3 mg/kg beginning C1D8. At the End of Cycle 2 (EOC2), ongoing patients will crossover to Sym004; crossover may occur prior to the EOC2 in the event of early radiographic documentation of progressive disease (PD).
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
100.0%
2/2 • 4 months
|
100.0%
1/1 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • 4 months
|
0.00%
0/1 • 4 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • 4 months
|
0.00%
0/1 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication before the completion of the trial without written approval from the Sponsor. Publications shall not disclose any Sponsor confidential information and property (not including the trial results). The Sponsor reserves the right to review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER