Clinical trial · Interventional
PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). The antitumor activity of CX-2029 will be evaluated in subjects with head and neck squamous cell carcinoma (HNSCC), DLBCL, non-small cell lung cancer (NSCLC) (squamous cell histology only), or esophageal (esophageal adenocarcinoma \[EAC\], esophageal squamous cell carcinoma \[ESCC\], or gastroesophageal \[GE\] junction) cancer. PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CX-2029 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- CX-2029 Escalation
- description
- Dose Escalation and Determination
- interventionNames
- Drug: CX-2029
- type
- EXPERIMENTAL
- label
- CX-2029 Biomarker
- description
- Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types
- interventionNames
- Drug: CX-2029
- type
- EXPERIMENTAL
- label
- CX-2029 Expansion
- description
- Evaluate antitumor activity of CX-2029
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors 2. Patients demonstrating disease progression after treatment with approved therapies that are known to confer life-prolonging benefit, or who are intolerant to or have declined treatment 3. Agreement to provide mandatory archival tissue or fresh biopsy 4. At least 18 years of age 5. For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor 6. For Arms B and C, histologically or cytologically confirmed metastatic or locally advanced unresectable HNSCC, DLBCL, NSCLC (squamous cell histology only), or esophageal (EAC, ESCC, or GE junction) cancer 7. Additional inclusion criteria may apply Exclusion Criteria: 1. Neuropathy \> Grade 1 2. Serious concurrent illness, including clinically relevant active infection 3. Clinically significant iron metabolism disorders (eg, sickle cell anemia) 4. Significant cardiac disease such as recent myocardial infarction 5. History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease; 6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm; 7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy; 8. Currently receiving anticoagulation therapy with warfarin; 9. Major surgery (requiring general anesthesia) within 3 months prior to dosing. 10. Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C) 11. Transfusion dependent anemia with transfusion dependency of ≥3 months 12. Use of iron chelators 13. Additional exclusion criteria may apply
References
Publications (0)
Data not yet available