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An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined with Atezolizumab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506820-10-00
Acronym
GO29781
Enrollment
65
Registered
2024-06-10
Start date
2024-06-11
Completion date
2025-09-01
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Malignancies

Brief summary

1. Safety: Incidence and nature of dose-limiting toxicity (DLTs) when mosunetuzumab is given as a single agent IV or SC, 2. Safety: Incidence and nature of DLTs when mosunetuzumab is given in combination with atezolizumab, 3. Efficacy: Independent Review Facility (IRF)-assessed complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR based upon IRF assessment using standard criteria for NHL, 4. PK: Serum concentration of mosunetuzumab at specified timepoints, 5. PK: The following PK parameters (if data allows): AUC, Cmax, Cmin, CL, and Vss, 6. PK: Other parameters such as accumulation ratio, half-life, and dose proportionality may also be calculated, 7. PKNI: Observed Cycle 3 (i.e., pre-dose Cycle 4) serum Ctrough concentration (CtroughCYC3_OBS), 8. PKNI: Cumulative AUC over 0−84 days (AUC0-84)

Detailed description

1. Safety: Incidence, nature, and severity of adverse events (AEs), 2. Safety: Incidence of anti-drug antibodies (ADAs) against mosunetuzumab and atezolizumab, and their relationship to clinical outcomes, 3. Safety: Changes in vital signs and clinical laboratory values, 4. Efficacy: Investigator-assessed CR rate, defined as the proportion of patients whose best overall response is a CR based upon investigator assessment using standard criteria for NHL, 5. Efficacy: IRF and investigator assessed objective response rate (ORR), defined as the proportion of patients whose best overall response is a PR or CR using standard criteria for NHL, 6. Efficacy: IRF and investigator assessed duration of complete response, defined as the time from the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first, using standard criteria for NHL, 7. Efficacy: IRF and investigator assessed duration of response, defined as the time from the initial occurrence of a documented PR or CR until documented disease progression or death due to any cause, whichever occurs first, using standard criteria for NHL, 8. Efficacy: IRF and investigator assessed progression-free survival (PFS), defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first, using standard criteria for NHL, 9. Efficacy: Overall survival (OS), defined as the time from the first study treatment to the date of death from any cause, 10. PRO: The HRQoL and health status measures that will be used in NHL expansion cohorts to evaluate PROs are as follows: Summary statistics and change from baseline in HRQoL based on EORTC QLQ C30 Summary statistics and change from baseline in disease-related symptoms based on the FACT-Lym subscale Descriptive results of the EQ-5D-5L data during patients’ participation in the study, 11. Pharmacokinetic Non-Inferiority (PKNI): Observed Cycle 2 (i.e., pre-dose Cycle 3) serum Ctrough concentration (CtroughCYC2_OBS), 12. PKNI: Modeled Cycle 2 (i.e., pre-dose Cycle 3) serum Ctrough concentration (CtroughCYC2), derived using EBEs or virtual trial simulations, data permitting, 13. PKNI: Modeled Cycle 3 (pre-dose Cycle 4) serum Ctrough concentration (CtroughCYC3), derived using EBEs or virtual trial simulations, data permitting, 14. PKNI: Modeled AUC at steady state (AUCSS), as approximated by AUC of Cycle 4 using EBEs or virtual trial simulations, data permitting

Interventions

DRUGMosunetuzumab
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Sponsors

Genentech Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Safety: Incidence and nature of dose-limiting toxicity (DLTs) when mosunetuzumab is given as a single agent IV or SC, 2. Safety: Incidence and nature of DLTs when mosunetuzumab is given in combination with atezolizumab, 3. Efficacy: Independent Review Facility (IRF)-assessed complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR based upon IRF assessment using standard criteria for NHL, 4. PK: Serum concentration of mosunetuzumab at specified timepoints, 5. PK: The following PK parameters (if data allows): AUC, Cmax, Cmin, CL, and Vss, 6. PK: Other parameters such as accumulation ratio, half-life, and dose proportionality may also be calculated, 7. PKNI: Observed Cycle 3 (i.e., pre-dose Cycle 4) serum Ctrough concentration (CtroughCYC3_OBS), 8. PKNI: Cumulative AUC over 0−84 days (AUC0-84)

Secondary

MeasureTime frame
1. Safety: Incidence, nature, and severity of adverse events (AEs), 2. Safety: Incidence of anti-drug antibodies (ADAs) against mosunetuzumab and atezolizumab, and their relationship to clinical outcomes, 3. Safety: Changes in vital signs and clinical laboratory values, 4. Efficacy: Investigator-assessed CR rate, defined as the proportion of patients whose best overall response is a CR based upon investigator assessment using standard criteria for NHL, 5. Efficacy: IRF and investigator assessed objective response rate (ORR), defined as the proportion of patients whose best overall response is a PR or CR using standard criteria for NHL, 6. Efficacy: IRF and investigator assessed duration of complete response, defined as the time from the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first, using standard criteria for NHL, 7. Efficacy: IRF and investigator assessed duration of response, defined as the time from the

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026