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

NCT03013491 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: CTMX-M-072-001
• Study Type: interventional
• Target: 196
• Locations: 6 countries
• Sites: 31

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 U.S. registered trademark of CytomX Therapeutics, Inc.

Conditions

Solid Tumor; Lymphoma

Keywords

cancer; checkpoint inhibitor; monotherapy; combination; PD-L1; CTLA-4; solid tumor; lymphoma; BRAF; PROCLAIM; CX-072; PROCLAIM-CX-072

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib

  Adverse events (AEs) that were considered DLTs: * Grade 5 AEs * Grade 4 AEs judged by the Investigator to be treatment-related or judged by the Sponsor as a DLT, regardless of Investigator-attribution (with some exceptions) • Any Grade 4 endocrinopathy. * Grade 3 AEs judged by the Investigator to be treatment-related or by the Sponsor, regardless of Investigator-attribution (with some exceptions) • Any Grade 3 central nervous system event, regardless of duration or reversibility. * Grade 2 pneumonitis necessitating CX-072 discontinuation * Grade 2 ocular toxicity necessitating CX-072 discontinuation

  28 days (dose limiting toxicity period)

Secondary Outcomes (1)

• The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy

  2 years

Study Arms (7)

CX-072 #1

EXPERIMENTAL

Monotherapy CX-072 (Part A)

Drug: CX-072

CX-072 #2

EXPERIMENTAL

Monotherapy CX-072 (Part A2)

Drug: CX-072

CX-072 with Ipilimumab #1

EXPERIMENTAL

Combination CX-072 + ipilimumab (Part B1)

Drug: CX-072; Drug: ipilimumab

CX-072 with Ipilimumab #2

EXPERIMENTAL

Combination CX-072 + ipilimumab (Part B2)

Drug: CX-072; Drug: ipilimumab

CX-072 with Vemurafenib

EXPERIMENTAL

Combination CX-072 + vemurafenib (Part C)

Drug: CX-072; Drug: vemurafenib

CX-072 expansion

EXPERIMENTAL

Monotherapy CX-072 (Part D)

Drug: CX-072

CX-072 long-term extension

EXPERIMENTAL

Monotherapy CX-072

Drug: CX-072

Interventions

CX-072 DRUG

Solution for infusion

CX-072 #1; CX-072 #2; CX-072 expansion; CX-072 long-term extension; CX-072 with Ipilimumab #1; CX-072 with Ipilimumab #2; CX-072 with Vemurafenib

ipilimumab DRUG

Solution for infusion

CX-072 with Ipilimumab #1; CX-072 with Ipilimumab #2

vemurafenib DRUG

Tablet

CX-072 with Vemurafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
• History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.
• 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.
• 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.
• History of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications.
• History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
• Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.
• 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.

Sponsors & Collaborators

• CytomX Therapeutics: lead

Study Sites (31)

PROCLAIM Investigative Site

Los Angeles, California, 90025, United States

Location

PROCLAIM Investigative Site

Los Angeles, California, 90033, United States

Location

PROCLAIM Investigative Site

New Haven, Connecticut, 06520, United States

Location

PROCLAIM Investigative Site

Chicago, Illinois, 60612, United States

Location

PROCLAIM Investigative Site

Indianapolis, Indiana, 46202, United States

Location

PROCLAIM Investigative Site

Boston, Massachusetts, 02215, United States

Location

PROCLAIM Investigative Site

Detroit, Michigan, 48201, United States

Location

PROCLAIM Investigative Site

New York, New York, 10016, United States

Location

PROCLAIM Investigative Site

New York, New York, 10032, United States

Location

PROCLAIM Investigative Site

New York, New York, 10065, United States

Location

PROCLAIM Investigative Site

Portland, Oregon, 97213, United States

Location

PROCLAIM Investigative Site

Nashville, Tennessee, 37203, United States

Location

PROCLAIM Investigative Site

Dallas, Texas, 75230, United States

Location

PROCLAIM Investigative Site

Houston, Texas, 77030, United States

Location

PROCLAIM Investigative Site

Fairfax, Virginia, 22031, United States

Location

PROCLAIM Investigative Site

Madison, Wisconsin, 53579, United States

Location

PROCLAIM Investigative Site

Amsterdam, 1007, Netherlands

Location

PROCLAIM Investigative Site

Groningen, 9713 GZ, Netherlands

Location

PROCLAIM Investigative Site

Rotterdam, 3000 CA, Netherlands

Location

PROCLAIM Investigative Site

Katowice, 40-960, Poland

Location

PROCLAIM Investigative Site

Pamplona, Navarre, 31008, Spain

Location

PROCLAIM Investigative Site

Barcelona, 08908, Spain

Location

PROCLAIM Investigative Site

Barcelona, 8036, Spain

Location

PROCLAIM Investigative Site

Madrid, 28046, Spain

Location

PROCLAIM Investigative Site

Madrid, 28050, Spain

Location

PROCLAIM Investigative Ssite

Valencia, 46009, Spain

Location

PROCLAIM Investigative Site

Dnipro, 49102, Ukraine

Location

PROCLAIM Invetigative Site

Glasgow, G12 0YN, United Kingdom

Location

PROCLAIM Investigative Site

London, W1G 6AD, United Kingdom

Location

PROCLAIM Investigative Site

Manchester, M20 4BX, United Kingdom

Location

PROCLAIM Investigative Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (3)

• Naing A, Thistlethwaite F, De Vries EGE, Eskens FALM, Uboha N, Ott PA, LoRusso P, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Randhawa M, Durm G, Gil-Martin M, Stroh M, Hannah AL, Arkenau HT, Spira A. CX-072 (pacmilimab), a Probody (R) PD-L1 inhibitor, in advanced or recurrent solid tumors (PROCLAIM-CX-072): an open-label dose-finding and first-in-human study. J Immunother Cancer. 2021 Jul;9(7):e002447. doi: 10.1136/jitc-2021-002447.

  PMID: 34301809 DERIVED

• Sanborn RE, Hamid O, de Vries EG, Ott PA, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Cho DC, Plummer R, Stroh M, Lu L, Thistlethwaite F. CX-072 (pacmilimab), a Probody PD-L1 inhibitor, in combination with ipilimumab in patients with advanced solid tumors (PROCLAIM-CX-072): a first-in-human, dose-finding study. J Immunother Cancer. 2021 Jul;9(7):e002446. doi: 10.1136/jitc-2021-002446.

  PMID: 34301808 DERIVED

• Giesen D, Broer LN, Lub-de Hooge MN, Popova I, Howng B, Nguyen M, Vasiljeva O, de Vries EGE, Pool M. Probody Therapeutic Design of 89Zr-CX-072 Promotes Accumulation in PD-L1-Expressing Tumors Compared to Normal Murine Lymphoid Tissue. Clin Cancer Res. 2020 Aug 1;26(15):3999-4009. doi: 10.1158/1078-0432.CCR-19-3137. Epub 2020 Jan 17.

  PMID: 31953313 DERIVED

MeSH Terms

Conditions

Lymphoma; Neoplasms; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Ipilimumab; Vemurafenib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: CytomX Therapeutics, Inc.

clinicaltrials@cytomx.com

(650) 515-3185

Study Officials

• Monika Vainorius, M.D.

  CytomX Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: January 6, 2017
• Study Start: January 19, 2017
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2020
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-05

Locations

US (16); PL (1); NL (3); UA (1); ES (6); GB (4)