Trial Outcomes & Findings for An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma (NCT NCT05315713)
NCT ID: NCT05315713
Last Updated: 2024-10-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
Results posted on
2024-10-04
Participant Flow
Participant milestones
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Progressive disease
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study terminated by sponsor
|
1
|
Baseline Characteristics
An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=8 Participants
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
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Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)Outcome measures
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=8 Participants
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
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Percentage of Participants With Adverse Events - Phase 1b
|
100 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Cycle 17 (cycle length = 21 days)Population: This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days)Best ORR is defined as the fraction of participants with complete response (CR) or partial response (PR) at any time as determined by the investigator using Lugano 2014 criteria.
Outcome measures
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=8 Participants
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
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Best ORR as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b
|
62.5 Percentage of participants
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SECONDARY outcome
Timeframe: Cycle 1 Day 1 - Cycle 8 Day 1 (cycle length = 21 days)Population: The PK population included all participants with at least one serum sample post-dose for mosunetuzumab.
Outcome measures
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=8 Participants
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
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Serum Concentration of Mosunetuzumab - Phase 1b
C2D1 pre-dose
|
4.02 ug/mL
Geometric Coefficient of Variation 86.3
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C1D1 pre-dose
|
NA ug/mL
Geometric Coefficient of Variation NA
Pre-dose serum concentrations were below the limit of quantification.
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C1D1 3 hrs post-dose
|
0.00983 ug/mL
Geometric Coefficient of Variation NA
There were insufficient data points above the limit of quantification to calculate the CV.
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|
Serum Concentration of Mosunetuzumab - Phase 1b
C1D2 24 hrs post-dose
|
0.0556 ug/mL
Geometric Coefficient of Variation 109.6
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C1D4 72 hrs post-dose
|
0.164 ug/mL
Geometric Coefficient of Variation 90.5
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C1D8 pre-dose
|
0.166 ug/mL
Geometric Coefficient of Variation 83.2
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C1D15 pre-dose
|
2.18 ug/mL
Geometric Coefficient of Variation 48.8
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C3D1 pre-dose
|
2.90 ug/mL
Geometric Coefficient of Variation 81.8
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C4D1 pre-dose
|
2.34 ug/mL
Geometric Coefficient of Variation 49.0
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C4D1 3 hrs post-dose
|
2.10 ug/mL
Geometric Coefficient of Variation 48.2
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C5D1 pre-dose
|
2.59 ug/mL
Geometric Coefficient of Variation 25.7
|
|
Serum Concentration of Mosunetuzumab - Phase 1b
C8D1 pre-dose
|
2.97 ug/mL
Geometric Coefficient of Variation 17.7
|
SECONDARY outcome
Timeframe: Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days)Outcome measures
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=8 Participants
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
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Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b
|
37.5 Percentage of participants
|
SECONDARY outcome
Timeframe: From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)Population: Phase 1b is reported. No data was collected for Phase 2.
Outcome measures
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=5 Participants
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
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Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b and Phase 2
|
NA Time
The endpoint could not be analyzed due to an insufficient number of participants with the event.
|
SECONDARY outcome
Timeframe: From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)Population: This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)Population: This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time of first study treatment to death from any cause (up to approximately 4 years)Population: This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of treatment until 90 days after the final dose of study treatmentPopulation: This endpoint was not evaluated due to early study termination (Phase 2 did not occur and no data was collected).
Outcome measures
Outcome data not reported
Adverse Events
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=8 participants at risk
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Pneumonia aspiration
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Septic shock
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Cerebellar haematoma
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
Other adverse events
| Measure |
Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab
n=8 participants at risk
Participants received SC mosunetuzumab on Cycle (C) 1 Day (D) 1, C1D8, C1D15, and on the first day of each subsequent 21-day treatment cycle. Participants also received IV tiragolumab every 3 weeks (Q3W).
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8 • Number of events 4 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
2/8 • Number of events 4 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Ear and labyrinth disorders
Ear congestion
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Retinal detachment
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Malignant dysphagia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
General disorders
Asthenia
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
General disorders
Injection site reaction
|
37.5%
3/8 • Number of events 4 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
General disorders
Oedema peripheral
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Immune system disorders
Cytokine release syndrome
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Rhinovirus infection
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Cachexia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
25.0%
2/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
37.5%
3/8 • Number of events 4 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 2 • From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER