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

Phase 1

Completed

• Conditions: Solid Tumor; Lymphoma
• Interventions: Drug: CX-072; Drug: ipilimumab; Drug: vemurafenib

• Registration Number: NCT03013491
• Lead Sponsor: CytomX Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-26
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-06
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CX-072 with Vemurafenib	CX-072	Combination CX-072 + vemurafenib
CX-072 with Ipilimumab #1	CX-072	Combination CX-072 + ipilimumab (Schedule 1)
CX-072 with Ipilimumab #2	CX-072	Combination CX-072 + ipilimumab (Schedule 2)
CX-072	CX-072	Monotherapy CX-072
CX-072 expansion	CX-072	Monotherapy CX-072
CX-072 with Ipilimumab #1	ipilimumab	Combination CX-072 + ipilimumab (Schedule 1)
CX-072 with Ipilimumab #2	ipilimumab	Combination CX-072 + ipilimumab (Schedule 2)
CX-072 with Vemurafenib	vemurafenib	Combination CX-072 + vemurafenib

Primary Outcome Measures

Name	Time	Method
The number of subjects experiencing a dose limiting toxicity at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib	28 days (dose limiting toxicity period)

Secondary Outcome Measures

Name	Time	Method
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib	2 Years

Trial Locations

Locations (3)

PROCLAIM Invetigative Site; 🇬🇧 Glasgow, United Kingdom

PROCLAIM Investigative Site; 🇬🇧 Newcastle upon Tyne, United Kingdom

PROCLAIM Investigative Ssite; 🇪🇸 Valencia, Spain