Brief Summary
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
PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
Brief Title
PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
Detailed Description
This is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging treatment options for their malignancy.
The study is divided into 3 parts (arms), as follows:
* Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D)
* Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A
* Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A
The study is divided into 3 parts (arms), as follows:
* Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D)
* Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A
* Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A
Categories
Completion Date
Completion Date Type
Actual
Conditions
Solid Tumor, Adult
Head and Neck Cancer
Non Small Cell Lung Cancer
Diffuse Large B Cell Lymphoma
Esophageal Cancer
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
cancer
solid tumor
DLBCL
CX-2029
PROBODY™ Therapeutic
Drug Conjugate
Antibody drug conjugate
CD71
Transferrin receptor 1
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03543813
Org Class
Industry
Org Full Name
CytomX Therapeutics
Org Study Id
CTMX-M-2029-001
Overall Status
Completed
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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)
Primary Outcomes
Outcome Measure
The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy
Outcome Time Frame
21 days (dose-limiting toxicity period)
Secondary Outcomes
Outcome Time Frame
2 years
Outcome Measure
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luca Paoluzzi
Investigator Email
lpaoluzzi@montefiore.org
Investigator Phone
6470000000