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

CytomX

Status and phase: Completed; Phase 2; Phase 1

Conditions: Esophageal Cancer; Solid Tumor, Adult; Non Small Cell Lung Cancer; Head and Neck Cancer; Diffuse Large B Cell Lymphoma

Treatments: Drug: CX-2029

Study type: Interventional

Funder types: Industry

Identifiers

NCT03543813

CTMX-M-2029-001

Details and patient eligibility

About

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

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

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 3 patient groups

CX-2029 Escalation

Experimental group

Description:

Dose Escalation and Determination

Treatment:

Drug: CX-2029

CX-2029 Biomarker

Experimental group

Description:

Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types

Treatment:

Drug: CX-2029

CX-2029 Expansion

Experimental group

Description:

Evaluate antitumor activity of CX-2029

Treatment:

Drug: CX-2029