ClinTrial Refer

Trial Acronym
CaDAnCe-101

Registration Number
NCT05006716

Scientific Title
A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies

Study consists of two main parts to explore BGB-16673 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)

1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL) , Follicular Lymphoma (FL), R/R Mantle Cell Lymphoma (MCL), R/R chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), Diffuse large B-cell lymphoma (DLBCL), or >2 treatments per the Richter's transformation to DLBCL.
2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
4. Measurable disease by radiographic assessment or serum IgM level (WM only)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
6. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).

1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
2. Requires ongoing systemic treatment for any other malignancy
3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).

Trial Location Name

Address

Status

Calvary Mater Newcastle Hospital (Haematology)

Edith St & Platt St, Waratah NSW 2298, Australia

Recruiting

Primary Contact : Kath Hall, Kathy.Hall@calvarymater.org.au , 02 4014 4891

Concord Repatriation General Hospital (Haematology)

Hospital Rd, Concord NSW 2139, Australia

Recruiting

Primary Contact : Jennifer Harman, SLHD-ConcordHaematologyClinicalResearch@health.nsw.gov.au , 02 9767 6348

Peninsula Private Hospital

Peninsula Private Hospital, McClelland Drive, Frankston VIC, Australia

Recruiting

Primary Contact : David McArdle, McArdleD@ramsayhealth.com.au , (03) 9788 3647

Secondary Contact : Fatima Husaini, HusainiF@ramsayhealth.com.au , (03) 9788 0993

Perth Blood Institute

Perth Blood Institute, Prowse Street, West Perth WA, Australia

Recruiting

Primary Contact : Jarod Horobin, jarod@pbi.org.au , 08 9200 5303

Princess Alexandra Hospital (Haematology)

199 Ipswich Rd, Woolloongabba QLD 4102, Australia

Recruiting

Primary Contact : David Barnes, david.barnes2@health.qld.gov.au , +617 3176 6827

Secondary Contact : Steven Ivanhoe, steven.ivanhoe@health.qld.gov.au , (07) 3176 6826

BeiGene

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT05006716

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT05006716

Secondary IDs
BGB-16673-101

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 1/Phase 2

Minimum Age
18

Maximum Age
100

Date Registered
18/10/2021

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
Yes

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Cohort Details

Cohort Name

Description

Status

Part 1a Monotherapy Dose Escalation

MZL; FL Grade 1, 2, and 3a; MCL; CLL/SLL; diffuse large B-cell lymphoma (DLBCL); Richter’s transformation (RT); and WM

Closed

Part 1b Monotherapy Safety Expansion

MZL; MCL; CLL/SLL; and WM

Closed

Part 2 Monotherapy Dose Expansion - Cohort 1

R/R CLL/SLL previously treated with a BTK inhibitor

Open

Part 2 Monotherapy Dose Expansion - Cohort 2

R/R blastoid or non-blastoid-variant MCL previously treated with a BTK inhibitor

Open

Discipline

Health Condition

Back to List/Filter

to List/Filter