Description:
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)
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CTMX-M-072-002
- NCT ID:
NCT03993379
Conditions
- Solid Tumor
- Unresectable or Metastatic Melanoma
Interventions
Drug | Synonyms | Arms |
---|
CX-072 | | CX-072 in combination with anti-cancer therapy-Neoadjuvant |
Ipilimumab | | CX-072 in combination with ipilimumab |
Purpose
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)
Trial Arms
Name | Type | Description | Interventions |
---|
CX-072 in combination with anti-cancer therapy-front line | Experimental | histologically or cytologically confirmed solid tumor who have received no prior treatment | |
CX-072 in combination with ipilimumab | Experimental | 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-Progressed | Experimental | 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 anti-cancer therapy-Neoadjuvant | Experimental | neo-adjuvant study in subjects with histologically confirmed solid tumor | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate by RECIST v 1,1 |
Time Frame: | 1 year |
Safety Issue: | |
Description: | ORR by RECIST v1.1 |
Secondary Outcome Measures
Measure: | The percentage of patients experiencing Treatment Related Adverse Events |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Safety and Tolerability of CX-072 in Combination Therapy |
Measure: | The numbers of patients experiencing anti-tumor activity by irRECIST |
Time Frame: | 2 years |
Safety Issue: | |
Description: | ORR by irRECIST |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | CytomX Therapeutics |
Trial Keywords
- Combination
- ipilimumab
- Cancer
- checkpoint inhibitor
- PD-L1
- CTLA-4
- PROCLAIM
- PROCLAIM-CX-072
- Relapsed
- Refractory
Last Updated
July 23, 2020