A Phase 1-2 First-in-Human Study of CX-2029 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029)
Bert O'Neil, MD
Primary Investigator
Brief description of study
The study is being done to look at:
1. the possible side effects, safety and tolerability of CX-2029. 2. the highest dose of CX-2029 that can be taken safely (maximum tolerated dose, abbreviated as MTD). 3. evidence of anti-cancer activity responses in patients receiving CX-2029, including how long patients live. 4. whether or not your body develops antibodies to CX-2029 that may affect its ability to attach to your tumor (immunogenicity). 5. the amount of CX-2029 in your blood and how long CX-2029 stays in your body. 6. whether certain markers of iron metabolism affect the safety or activity of CX-2029 in your body. 7. whether CX-2029 binds to its target (CD71) in your body. 8. levels of certain markers which might help characterize the cancer within your tumor, blood or urine (for some patients). 9. how much CX-2029 is actually active within the tumor (for some patients).
Detailed description of study
This study will evaluate the safety, tolerability, and PK profile of CX-2029 as well as preliminary evidence of the antitumor activity of CX-2029. Through its dose escalation and safety, it will determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) for CX-2029 in adults with metastatic or locally advanced unresectable solid tumors or DLBCL without approved life-prolonging treatment options for their malignancy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: diffuse large B-cell lymphoma,non-small cell lung cancer,pancreatic cancer,1805728059
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Age: 18 years - 100 years
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Gender: All
