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

• ClinicalTrials.gov Identifier: NCT03993379
• Recruitment Status: Terminated
• First Posted: June 20, 2019
• Results First Posted: December 1, 2021
• Last Update Posted: December 1, 2021
• Sponsor: CytomX Therapeutics
• Information provided by (Responsible Party): CytomX Therapeutics

Tracking Information

• First Submitted Date: May 14, 2019
• First Posted Date: June 20, 2019
• Results First Submitted Date: September 2, 2021
• Results First Posted Date: December 1, 2021
• Last Update Posted Date: December 1, 2021
• Actual Study Start Date: November 20, 2019
• Actual Primary Completion Date: May 21, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2021)

Overall Response Rate by RECIST v 1.1 [ Time Frame: 1 year ]

ORR by RECIST v1.1

Original Primary Outcome Measures (submitted: June 19, 2019)

Overall response rate by RECIST v 1,1 [ Time Frame: 1 year ]

ORR by RECIST v1.1

Current Secondary Outcome Measures (submitted: September 2, 2021)

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

Original Secondary Outcome Measures (submitted: June 19, 2019)

• The percentage of patients experiencing Treatment Related Adverse Events [ Time Frame: 2 years ]
  Safety and Tolerability of CX-072 in Combination Therapy
• The numbers of patients experiencing anti-tumor activity by irRECIST [ Time Frame: 2 years ]
  ORR by irRECIST

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
• Official Title: A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Solid Tumor
• Unresectable or Metastatic Melanoma

Intervention

• Drug: CX-072
  CX-072 in combination with ipilimumab
• Drug: Ipilimumab
  CX-072 in combination with ipilimumab

Study Arms

• Experimental: CX-072 in combination with anti-cancer therapy-front line
  histologically or cytologically confirmed solid tumor who have received no prior treatment
  Intervention: Drug: CX-072
• Experimental: CX-072 in combination with 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
  Interventions:

  • Drug: CX-072
  • Drug: Ipilimumab
• Experimental: CX-072 in combination with anti-cancer therapy-Progressed
  histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
  Intervention: Drug: CX-072
• Experimental: CX-072 in combination with anti-cancer therapy-Neoadjuvant
  neo-adjuvant study in subjects with histologically confirmed solid tumor
  Intervention: Drug: CX-072

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 8, 2020): 3
• Original Estimated Enrollment (submitted: June 19, 2019): 160
• Actual Study Completion Date: May 21, 2020
• Actual Primary Completion Date: May 21, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Korea, Republic of, Netherlands, Spain, United States

Administrative Information

• NCT Number: NCT03993379
• Other Study ID Numbers: CTMX-M-072-002
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CytomX Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: CytomX Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Lawrence Lu, MD; CytomX Therapeutics

• PRS Account: CytomX Therapeutics
• Verification Date: November 2021