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Trial Title:
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
NCT ID:
NCT06402201
Condition:
Select Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
IV dose escalation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CDR404
Description:
IV infusions
Arm group label:
CDR404
Summary:
CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody
designed for the treatment of cancers positive for the tumor-associated antigen
melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to
evaluate the safety, tolerability, and preliminary anti-tumor activity of CDR404 in adult
patients who have the appropriate germline human leukocyte antigen HLA-A*02:01 tissue
marker and whose cancer is positive for MAGE-A4.
Detailed description:
The CDR404-001 Phase 1 study will enrol patients with locally advanced, unresectable or
metastatic tumors expressing MAGE-A4, which include advanced solid tumors, and will be
conducted in multiple phases:
1. To identify the maximum tolerated dose (MTD) and pharmacologically effective dose
range (PEDR) for CDR404
2. To assess preliminary evidence of anti-tumor activity of CDR404
3. To characterise the pharmacokinetics of CDR404
4. To characterise the immunogenicity of CDR404
5. To assess translational biomarkers
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provision of written informed consent
2. HLA-A*02:01 positive
3. MAGE-A4 positive tumor
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
5. Selected advanced solid tumors
6. Relapsed from, refractory to, or intolerant of standard therapy
7. Measurable disease per RECIST v1.1
8. Adequate organ function
9. If applicable, must agree to use highly effective contraception
Exclusion Criteria:
1. Symptomatic or untreated central nervous system metastasis
2. Inadequate washout from prior anticancer therapy
3. Significant ongoing toxicity from prior anticancer treatment
4. Recent surgery
5. Clinically significant cardiac disease
6. Active infection requiring systemic antibiotic treatment
7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome
(AIDS)-related outcomes
8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
10. Significant secondary malignancy
11. History of chronic or recurrent active autoimmune disease requiring treatment
12. Uncontrolled intercurrent illness
13. Pregnancy or lactation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Lauren Miro
Email:
lem183@med.miami.edu
Contact backup:
Phone:
+1-305-243-7590
Investigator:
Last name:
Gilberto de Lima Lopes, MD
Email:
Principal Investigator
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Answer Line
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Investigator:
Last name:
Paul Swiecicki, MD
Email:
Principal Investigator
Facility:
Name:
Providence Cancer Institute
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Providence Cancer Institute
Email:
CanRsrchStudies@providence.org
Contact backup:
Phone:
+1-503-215-5763
Investigator:
Last name:
Rom Leidner, MD
Email:
Principal Investigator
Facility:
Name:
Pennsylvania Hospital
Address:
City:
Philadelphia
Zip:
19106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Team
Phone:
215-829-7089
Email:
PAhemoncResearch@uphs.upenn.edu
Investigator:
Last name:
Mark Diamond, MD
Email:
Principal Investigator
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
DK-2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Phase 1 Unit
Email:
RH-FP-ThePhase1Unit@regionh.dk
Contact backup:
Phone:
+45 35 45 35 45
Investigator:
Last name:
Iben Spanggaard, MD
Email:
Principal Investigator
Start date:
May 24, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
CDR-Life AG
Agency class:
Industry
Source:
CDR-Life AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06402201
