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

Sponsor

CytomX Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03013491

Collaborator

(none)

300

Enrollment

Locations

Arms

57.1

Duration (Months)

9.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Lymphoma	Drug: CX-072 Drug: ipilimumab Drug: vemurafenib	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas

Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Oct 6, 2021

Actual Study Completion Date :

Oct 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CX-072 Monotherapy CX-072	Drug: CX-072
Experimental: CX-072 with Ipilimumab #1 Combination CX-072 + ipilimumab (Schedule 1)	Drug: CX-072 Drug: ipilimumab
Experimental: CX-072 with Ipilimumab #2 Combination CX-072 + ipilimumab (Schedule 2)	Drug: CX-072 Drug: ipilimumab
Experimental: CX-072 with Vemurafenib Combination CX-072 + vemurafenib	Drug: CX-072 Drug: vemurafenib
Experimental: CX-072 expansion Monotherapy CX-072	Drug: CX-072

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PROCLAIM Investigative Site	Los Angeles	California	United States	90025
2	PROCLAIM Investigative Site	Los Angeles	California	United States	90033
3	PROCLAIM Investigative Site	New Haven	Connecticut	United States	06520
4	PROCLAIM Investigative Site	Chicago	Illinois	United States	60612
5	PROCLAIM Investigative Site	Indianapolis	Indiana	United States	46202
6	PROCLAIM Investigative Site	Boston	Massachusetts	United States	02215
7	PROCLAIM Investigative Site	Detroit	Michigan	United States	48201
8	PROCLAIM Investigative Site	New York	New York	United States	10016
9	PROCLAIM Investigative Site	New York	New York	United States	10032
10	PROCLAIM Investigative Site	New York	New York	United States	10065
11	PROCLAIM Investigative Site	Portland	Oregon	United States	97213
12	PROCLAIM Investigative Site	Nashville	Tennessee	United States	37203
13	PROCLAIM Investigative Site	Dallas	Texas	United States	75230
14	PROCLAIM Investigative Site	Houston	Texas	United States	77030
15	PROCLAIM Investigative Site	Fairfax	Virginia	United States	22031
16	PROCLAIM Investigative Site	Madison	Wisconsin	United States	53579
17	PROCLAIM Investigative Site	Amsterdam		Netherlands	1007
18	PROCLAIM Investigative Site	Groningen		Netherlands	9713 GZ
19	PROCLAIM Investigative Site	Rotterdam		Netherlands	3000 CA
20	PROCLAIM Investigative Site	Katowice		Poland	40-960
21	PROCLAIM Investigative Site	Pamplona	Navarre	Spain	31008
22	PROCLAIM Investigative Site	Barcelona		Spain	08908
23	PROCLAIM Investigative Site	Barcelona		Spain	8036
24	PROCLAIM Investigative Site	Madrid		Spain	28046
25	PROCLAIM Investigative Site	Madrid		Spain	28050
26	PROCLAIM Investigative Ssite	Valencia		Spain	46009
27	PROCLAIM Investigative Site	Dnepropetrovsk		Ukraine	49102
28	PROCLAIM Invetigative Site	Glasgow		United Kingdom	G12 0YN
29	PROCLAIM Investigative Site	London		United Kingdom	W1G 6AD
30	PROCLAIM Investigative Site	Manchester		United Kingdom	M20 4BX
31	PROCLAIM Investigative Site	Newcastle upon Tyne		United Kingdom	NE7 7DN