PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

CytomX

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumor; Lymphoma

Treatments: Drug: vemurafenib; Drug: ipilimumab; Drug: CX-072

Study type: Interventional

Funder types: Industry

Identifiers

NCT03013491

CTMX-M-072-001

Details and patient eligibility

About

The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial

CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity.

PROBODY is a trademark of CytomX Therapeutics, Inc.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy
2. Agreement to provide mandatory archival tissue or fresh biopsy.
3. At least 18 years of age.

Exclusion criteria

1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.
3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.
4. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.
5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.
6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.
8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 5 patient groups

CX-072

Experimental group

Description:

Monotherapy CX-072

Treatment:

Drug: CX-072

CX-072 with Ipilimumab #1

Experimental group

Description:

Combination CX-072 + ipilimumab (Schedule 1)

Treatment:

Drug: ipilimumab

Drug: CX-072

CX-072 with Ipilimumab #2

Experimental group

Description:

Combination CX-072 + ipilimumab (Schedule 2)

Treatment:

Drug: ipilimumab

Drug: CX-072

CX-072 with Vemurafenib

Experimental group

Description:

Combination CX-072 + vemurafenib

Treatment:

Drug: CX-072

Drug: vemurafenib

CX-072 expansion

Experimental group

Description:

Monotherapy CX-072

Treatment:

Drug: CX-072