Lung Cancer Clinical Trial

PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL

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

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Full 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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
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
Agreement to provide mandatory archival tissue or fresh biopsy
At least 18 years of age
For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
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
Additional inclusion criteria may apply

Exclusion Criteria:

Neuropathy > Grade 1
Serious concurrent illness, including clinically relevant active infection
Clinically significant iron metabolism disorders (eg, sickle cell anemia)
Significant cardiac disease such as recent myocardial infarction
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;
Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
Currently receiving anticoagulation therapy with warfarin;
Major surgery (requiring general anesthesia) within 3 months prior to dosing.
Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
Transfusion dependent anemia with transfusion dependency of ≥3 months
Use of iron chelators
Additional exclusion criteria may apply

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT03543813

Recruitment Status:

Active, not recruiting

Sponsor:

CytomX Therapeutics

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Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT03543813

Recruitment Status:

Active, not recruiting

Sponsor:


CytomX Therapeutics

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