PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors

Phase 2

Terminated

• Conditions: Unresectable or Metastatic Melanoma; Solid Tumor
• Interventions: Drug: CX-072; Drug: Ipilimumab

• Registration Number: NCT03993379
• Lead Sponsor: CytomX Therapeutics

Brief Summary

To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Study Start: 2019-11-20
• Primary Completion: 2020-05-21
• Study Completion: 2020-05-21
• Results First Submitted: 2021-09-02
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Results First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. At least 18 years of age
2. Measurable disease as defined by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
4. Agree to provide tumor tissue and blood samples for biomarker assessment

Exclusion Criteria

1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
4. History of myocarditis regardless of the cause
5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CX-072 in combination with anti-cancer therapy-front line	CX-072	histologically or cytologically confirmed solid tumor who have received no prior treatment
CX-072 in combination with anti-cancer therapy-Progressed	CX-072	histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
CX-072 in combination with ipilimumab	CX-072	histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
CX-072 in combination with anti-cancer therapy-Neoadjuvant	CX-072	neo-adjuvant study in subjects with histologically confirmed solid tumor
CX-072 in combination with ipilimumab	Ipilimumab	histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor

Primary Outcome Measures

Name	Time	Method
Overall Response Rate by RECIST v 1.1	1 year	ORR by RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST	2 years	ORR by irRECIST
The Percentage of Patients Experiencing Treatment Related Adverse Events	2 years	Safety and Tolerability of CX-072 in Combination Therapy

Trial Locations

Locations (27)

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

The Angeles Clinic and Research Institute; 🇺🇸 Los Angeles, California, United States

Beacon Cancer Care; 🇺🇸 Coeur d'Alene, Idaho, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

NYC Cancer Institute; 🇺🇸 New York, New York, United States

Columbia Medical Center; 🇺🇸 New York, New York, United States

Oregon Health & Science Center; 🇺🇸 Portland, Oregon, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

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