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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06392477




Registration number
NCT06392477
Ethics application status
Date submitted
23/04/2024
Date registered
30/04/2024
Date last updated
18/06/2024

Titles & IDs
Public title
A Study of DR-0201 in Subjects With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Scientific title
A Multicenter, Multiple Expansion Cohort Phase 1 Study Evaluating the Safety and Activity of DR-0201 as Multiple Ascending Doses in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma
Secondary ID [1] 0 0
DR-0201-ONC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Non Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DR-0201

Experimental: DL1 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 0.3 mg DR-0201

Experimental: DL2 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 1 mg DR-0201

Experimental: DL3 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 3 mg DR-0201

Experimental: DL4 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 10 mg DR-0201

Experimental: DL5 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 30 mg DR-0201

Experimental: DL6 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 100 mg DR-0201

Experimental: DL7 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 300 mg DR-0201

Experimental: DL8 of DR-0201 - Subjects in this arm will receive up to 12 months of dosing with 500 mg DR-0201


Treatment: Drugs: DR-0201
DR-0201 is a bispecific antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events as assessed by CTCAE v5.0.(Safety and Tolerability)
Timepoint [1] 0 0
Up to 12 months

Eligibility
Key inclusion criteria
Key

* At least 2 prior lines of therapy and without treatment options that are recognized to offer clinical benefit
* Adequate marrow reserve, renal function, and hepatic function
* Measurable disease defined as = 1 bi-dimensionally measurable nodal lesion of > 1.5 cm in the longest dimension for subjects with PET avid disease for subtypes with nodular disease or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy of = 12 weeks
* Use of a highly effective contraceptive measure all males and all females of childbearing potential during study through 180 days post last dose; Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to first dose.
* Tumor tissue block or 3 to 5 unstained slides from lymph node or other relevant biopsy collected in the past 6 months or subject must be willing to provide a baseline biopsy, unless not safely accessible
* In subjects with prior CAR-T therapy, >90 days post CAR-T at day of first dosing

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Burkitt's or Burkitt's like lymphoma or lymphoplastic lymphoma
* Current or past history of central nervous system (CNS) lymphoma
* Prior allogeneic stem cell transplantation except for those with FL and MCL, who are excluded if transplant occurred less than 100 days prior to Screening or if they exhibit active signs of or received treatment for graft versus host disease (GvHD)
* Prior solid organ transplantation
* Autologous stem cell transplantation = 100 days
* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulamatosis, Sjorgen's syndrome, Guillain-Barre-syndrome, multiple sclerosis vasculitis, or glomerulonephritis (subjects with a remote history of, or well-controlled autoimmune disease, may be eligible)
* Major surgery in the last 28 days prior to dosing
* Evidence of significant, uncontrolled concomitant disease that could affect compliance with study
* Current or past history of CNS disease (Subjects with remote history of non-lymphoma CNS disease and with no residual neurologic deficits may be eligible to enroll)
* QT interval corrected by Fridericia's formula (QTcF) > 480 msec
* Significant cardiovascular disease
* Received systemic therapy with anti-cancer therapies 4 weeks prior to first DR-0201 administration or 5 half-lives of the drug, whatever is shorter. Treatment with corticosteroid = 25mg/day prednisone or equivalent is allowed. Inhaled and topical steroids are allowed.
* Prior treatment with systemic immunotherapy agents included, but not limited to radio immunoconjugates, antibody drug conjugates, cytokines, immune checkpoint inhibitors 4 weeks or 5 half-lives of the drug, whatever is shorter
* Positive hepatitis B virus (HBV) polymerase chain reaction (PCR) test. Subjects with a positive serologic test for HBV (i.e., positive hepatitis B core antibody [HBcAb] and negative for hepatitis B surface antigen [HBsAg]) must have a negative PCR test
* Known infection with HIV, HBV, or hepatitis C virus (HCV). Subjects who are HIV-positive with undetectable HIV RNA and at least 3 months on a highly effective antiviral therapy (HART) and subjects who are HCV-positive who have completed at least 1 month of highly effective antiviral therapy may be eligible.
* Acute bacterial, viral, or fungal infection at baseline
* Active infection requiring systemic (IV) treatment with antimicrobial, antifungal, or antiviral agents in the 2 weeks prior to dosing.
* Administration of a live, attenuated vaccine within 4 weeks prior to first DR-0201 administration or anticipation that such vaccine administration would be necessary during the course of the study
* Another invasive malignancy in the last 2 years (except basal cell carcinoma and tumors deemed by the investigator to be of low likelihood for recurrence)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Dren Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Dren Investigational Site - Douglas
Recruitment hospital [3] 0 0
Dren Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Busan
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Goyang-si
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Singapore
State/province [5] 0 0
Kent Ridge
Country [6] 0 0
Taiwan
State/province [6] 0 0
Chang Hua
Country [7] 0 0
Taiwan
State/province [7] 0 0
Kaohsiung
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dren Bio
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, multiple expansion cohort, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-0201 in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Trial website
https://clinicaltrials.gov/study/NCT06392477
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roel Funke, PhD
Address 0 0
Dren Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dren Central Contact
Address 0 0
Country 0 0
Phone 0 0
415-737-5277
Fax 0 0
Email 0 0
clinops@drenbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06392477