First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

Phase 1, First-in-Human Study to Assess the Safety, Tolerability and Anti-tumor Activity of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

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.

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

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.