Description:
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
Title
- 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
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CTMX-M-2029-001
- NCT ID:
NCT03543813
Conditions
- Solid Tumor, Adult
- Head and Neck Cancer
- Non Small Cell Lung Cancer
- Diffuse Large B Cell Lymphoma
- Esophageal Cancer
Interventions
Drug | Synonyms | Arms |
---|
CX-2029 | | CX-2029 Biomarker |
Purpose
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
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
Trial Arms
Name | Type | Description | Interventions |
---|
CX-2029 Escalation | Experimental | Dose Escalation and Determination | |
CX-2029 Biomarker | Experimental | Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types | |
CX-2029 Expansion | Experimental | Evaluate antitumor activity of CX-2029 | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy |
Time Frame: | 21 days (dose-limiting toxicity period) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | CytomX Therapeutics |
Trial Keywords
- cancer
- solid tumor
- DLBCL
- CX-2029
- PROBODY™ Therapeutic
- Drug Conjugate
- Antibody drug conjugate
- CD71
- Transferrin receptor 1
Last Updated
August 23, 2021