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A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies

Study acronym: CaDAnCe-101
StatusRecruiting
PhasePhase 1/2
Started2021-09-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 4 changed
See other at-risk trials from BeOne Medicines

Amendment history

The 50 most recent of 65 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-09
Study Status, Contacts/Locations v64
Study sitesdetails revised at 2 of 115 sites
2026-08-20
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures v63
Primary endpoint(s) modified4 entries, revised
WasPhase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-16673, Phase 1: Number of Participants with Adverse Events (AEs), Phase 1: Recommended dose(s) for Expansion (RDFE) of BGB-16673, Phase 2: Overall response rate (ORR)
NowPhase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Tacabrutideg, Phase 1: Number of Participants with Adverse Events (AEs), Phase 1: Recommended dose(s) for Expansion (RDFE) of tacabrutideg, Phase 2: Overall response rate (ORR)
InterventionsBGB-16673 (Drug)→Tacabrutideg (Drug)
Secondary endpoints30 entries, revised
Single dose and steady-state maximum observed plasma concentration (Cmax) of BGB-16673tacabrutideg Single dose and steady-state minimum observed plasma concentration (Cmin) of BGB-16673tacabrutideg Single dose and steady-state time to reach Cmax (tmax) of BGB-16673tacabrutideg Single dose and steady-state elimination half-life (T1/2) of BGB-16673tacabrutideg Single dose and steady-state area under the plasma concentration-time curve (AUC) of BGB-16673tacabrutideg Single dose and steady-state apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673tacabrutideg [...] [...]
Study title+15 characters
A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies
2026-08-18
Study Status, Contacts/Locations v62
Study sites114→115
2026-08-05
Study Status, Contacts/Locations v61
Trial sites reduced: 127 → 114 locations
2026-07-22
Study Status, Contacts/Locations v60
Study sitesdetails revised at 1 of 127 sites
2026-06-17
Study Status, Contacts/Locations v59
Trial sites reduced: 130 → 127 locations
2026-06-01
Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v58
Enrollment target614→645
Study sites128→130
Eligibility criteria+368 characters
[...] continued the BTK inhibitor due to toxicity or intolerance. Phase 2 Cohorts in R/R CLL/SLL, R/R MCL, and R/R WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were [...] Measurable disease by radiographic assessment or serum IgM l [...]
Secondary endpoints30 entries, revised
Single dose and steady-state time to reachelimination half of Cmax-life (T1/2) of BGB-16673 Phase 1: Number of Participants with AE [...] Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionairequestionnaire
2026-05-26
Study Status, Contacts/Locations v57
Study sites128 entries, revised
Mount Sinai Medical Center Braman Comprehensive Cancer Center
2026-05-08
Study Status, Contacts/Locations v56
Study sites127→128
2026-04-20
Study Status, Contacts/Locations v55
Study sites126→127
2026-04-14
Study Status, Contacts/Locations v54
Trial sites expanded: 120 → 126 locations
2026-03-17
Study Status, Contacts/Locations v53
Study sites113→120
2026-03-04
Study Status, Contacts/Locations v52
Study sites115→113
2026-02-20
Study Status, Contacts/Locations v51
Study sites113→115
2026-02-03
Study Status, Contacts/Locations v50
Study sites111→113
2026-01-21
Study Status, Contacts/Locations v49
Study sites109→111
2026-01-09
Study Status, Study Description, Contacts/Locations v48
Study sites108→109
Study description+209 characters
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
2025-11-07
Study Status, Contacts/Locations v47
Study sites111→108
2025-10-23
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v46
Study sites115→111
Lead sponsorBeiGene→BeOne Medicines
2025-10-02
Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility v45
Primary completion date2025-12-31→2026-11
Completion date2028-12-31→2029-11
Enrollment target621→614
Eligibility criteria-23 characters
[...] ted) of one of the following: Marginal Zone Lymphoma (MZL), FollicularR/R Lymphomafollicular lymphoma (FL), R/Rmantle Mantlecell Cell Lymphomalymphoma (MCL), R/R chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), DiffuseR/R diffuse large B-cell lymphoma (DLBCL), or >2 treatments per the Richter's transformation to DLBCL. Participants who have pre [...]
Secondary endpoints22 to 30 entries
Phase 1: NumberResponse ofRate in Participants with R/R CLL/SLL Phase 1: Overall Response Rate in Participants with R/R WM Participants with major response rate (MRR) Phase 2: CompleteORR in Participants with CLL/SLL assessed by investigators Phase 2: Major Response Rate for Participants with WM assessed by investigator Phase 2: Overall Response Rate for Participants with WM assessed by investigator and IRC Phase 2: Rate of Very Good Partial Response (CRRVGPR) or Better in Participants with WM Assessed by Investigator and IRC Phase 2: Response rateRate ofin minorParticipants responsewith orR/R [...]
2025-09-23
Study Status, Contacts/Locations v44
Study sites117→115
2025-08-19
Study Status, Contacts/Locations v43
Study sitesdetails revised at 10 of 117 sites
2025-07-22
Study Status, Contacts/Locations v42
Study sitesdetails revised at 2 of 117 sites
2025-06-23
Study Status, Contacts/Locations v41
Study sitesdetails revised at 1 of 117 sites
2025-06-04
Study Status, Contacts/Locations v40
Study sites119→117
2025-04-29
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 119 sites
2025-04-10
Study Status, Contacts/Locations v38
Study sites119 entries, revised
Universitaetsklinikum Ulm, Innere Medizin Iii
2025-03-21
Study Status, Contacts/Locations v37
Study sitesdetails revised at 2 of 119 sites
2025-03-07
Study Status, Contacts/Locations v36
Study sites118→119
2025-02-14
Study Status, Contacts/Locations, IPDSharing v35
Study sitesdetails revised at 1 of 118 sites
2025-01-27
Study Status, Contacts/Locations v34
Primary completion date2025-03-31→2025-12-31
Completion date2028-03-31→2028-12-31
Study sitesdetails revised at 2 of 118 sites
2025-01-10
Study Identification, Study Status, Contacts/Locations v33
Study sitesdetails revised at 4 of 118 sites
2024-12-13
Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v32
Enrollment target466→621
Study sites62→118
Study arms4→7
Secondary endpoints26 to 22 entries
Single Dosedose Maximumand steady-state maximum observed plasma concentration (Cmax) of BGB-16673 Single Dosedose Minimumand steady-state minimum observed plasma concentration (Cmin) of BGB-16673 Single Dosedose Timeand steady-state time to reach Cmax (tmax) of BGB-16673 Single Dosedose Timeand steady-state time to reach half of Cmax (T1/2) of BGB-16673 Single Dosedose Areaand steady-state area under the plasma concentration-time curve (AUC) of BGB-16673 Single Dosedose and steady-state apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673 Single Dosedose a [...] [...]
Primary endpoints4 entries, revised
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-16673 Phase 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and Adverse Events (AEs) Phase graded1: according NCI-CTCAE V5. Recommended Phasedose(s) 2for DoseExpansion (RP2DRDFE) of BGB-16673
2024-10-23
Study Status, Contacts/Locations v31
Study sites107→62
2024-10-16
Study Status, Contacts/Locations v30
Study sites105→107
2024-09-27
Study Status, Contacts/Locations v29
Study sites97→105
2024-08-16
Study Status, Contacts/Locations v28
Study sites96→97
2024-07-30
Study Status, Contacts/Locations v27
Study sites92→96
2024-07-22
Study Status, Contacts/Locations v26
Study sites84→92
2024-06-05
Study Status, Contacts/Locations v25
Study sites77→84
2024-05-29
Study Status, Contacts/Locations v24
Primary completion date2024-09-30→2025-03-31
Completion date2027-09-30→2028-03-31
Study sites58→77
2024-04-01
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v23
Enrollment target291→466
Study sites49→58
Eligibility criteria+637 characters
[...] oted) of one of the following: Marginal Zone Lymphoma (MZL) (Part 1a 1b, and 1c only), Follicular Lymphoma (FL), R/R Mantle Cell Lymphoma (Part 1a and 1c onlyMCL), R/R MCLchronic (partslymphocytic 1a, 1b,leukemia and 2small onlylymphocytic lymphoma (CLL/SLL), R/RWaldenström CLL/SLLmacroglobulinemia (Parts 1a, 1b, and 2WM), WMDiffuse large B-cell lymphoma (Part 1a and 1c only), DLBCL (Part 1a and 1c only), or >2 treatments per the Richter's transformation to DLBCL (Part 1a and 1c only). Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi [...] [...]
Secondary endpoints29 to 26 entries
PartPhase 1: Overall response rate (ORR) PartPhase 1: Number of Waldenström Macroglobulinemia (WM) Participants with major response rate (MRR) Part 2: Number of R/R MCL Participants with overall response rate (ORR) Part 2: Number of R/R CLL/SLL Participants with overall response rate (ORR) PartPhase 2: Duration of Response (DOR) for R/R MCL Participants Part 2: Duration of Response (DOR) for R/R CLL/SLL Participants PartPhase 2: Time to Response (TTR) for R/R MCL Participants Part 2: Time to Response (TTR) for R/R CLL/SLL Participants PartPhase 2: Progression- Free Survival (PFS) for R/R MCL P [...] [...]
Primary endpoints5 to 4 entries
Part 2: ORR in relapsed/refractory chronic/small lymphocytic lymphoma (R/R CLL/SLL) Participants PartPhase 2: Overall response rate (ORR) in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Participants
2024-02-02
Study Status, Contacts/Locations v22
Study sites45→49
2024-01-17
Study Status, Contacts/Locations v21
Study sites44→45
2024-01-03
Study Status, Contacts/Locations v20
Study sites42→44
2023-11-08
Study Status, Contacts/Locations v19
Study sites38→42
2023-11-02
Study Status, Contacts/Locations v18
Study sites35→38
2023-10-08
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v17
PhasePhase 1→Phase 1/2
Enrollment target232→291
Study sites27→35
Study arms1→4
Eligibility criteria+59 characters
Inclusion Criteria : Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection Age ≥ 18 years Confirmed diagnosis (per World Health Organization [(WHO]) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL) (Part 1a 1b, and 1c only), Follicular Lymphoma (FL) (Part 1a and 1b1c only), FLR/R MCL (Partparts 1a, 1b, and 2 only), MCL,R/R CLL/SLL (Parts 1a, 1b, and 2), WM (Part 1a and 1b1c only), DLBCL (Part 1a and 1c only), or >2 treatments per the Richter's transformation to DLBCL (Part 1a and 1c o [...] [...]
Secondary endpoints18 to 29 entries
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood uponafter BGB-16673 monotherapy Part 1: Overall response rate (ORR) Part 1: Number of Waldenström Macroglobulinemia (WM) Participants with major response rate (MRR) Part 2: Number of R/R MCL Participants with overall response rate (ORR) Part 2: Number of WMR/R CLL/SLL Participants with majoroverall response rate (MRRORR) Part 2: Duration of Response (DOR) for R/R MCL Participants Part 2: Duration of Response (DOR) for R/R CLL/SLL Participants Part 2: Time to Response (TTR) for R/R MCL Participants Part 2: Time to Response ( [...] [...]
Primary endpoints2 to 5 entries
Maximum Tolerated Dose (MTD) of BGB-16673 Number of Participants Reporting One or More Treatment-emerg [...] (SAEs) with adverse events leading to discontinuation, and Adverse Events (AEs) graded according NCI-CTCAE V5. Part 2: ORR in relapsed/refractory chronic/small lymphocytic lymphoma (R/R CLL/SLL) Participants Part 2: Overall response rate (ORR) in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Participants Recommended Phase 2 Dose (RP2D) of Orally Administered BGB-16673
Study title-4 characters
A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in PatientsParticipants With B-Cell Malignancies
2023-08-23
Study Status, Contacts/Locations v16
Study sites23→27
2023-07-17
Study Status, Contacts/Locations v15
Study sites17→23
BeOne Medicines
59 trials monitored
See 7 trials at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
Non-Hodgkin Lymphoma
1,512 trials monitored
See 79 trials at risk
DLBCL
648 trials monitored
See 32 trials at risk
and 3 more diseases
Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
Trial Details
NCT Number NCT05006716
Lead Sponsor BeOne Medicines
Conditions B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Waldenström Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma +1 more
Enrollment 645 participants
Start Date 2021-09-13
Primary Completion 2026-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-28