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

CytomX

Status and phase: Terminated; Phase 2

Conditions: Solid Tumor; Unresectable or Metastatic Melanoma

Treatments: Drug: Ipilimumab; Drug: CX-072

Study type: Interventional

Funder types: Industry

Identifiers

NCT03993379

CTMX-M-072-002

Details and patient eligibility

About

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)

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 4 patient groups

CX-072 in combination with anti-cancer therapy-front line

Experimental group

Description:

histologically or cytologically confirmed solid tumor who have received no prior treatment

Treatment:

Drug: CX-072

CX-072 in combination with ipilimumab

Experimental group

Description:

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

Treatment:

Drug: CX-072

Drug: Ipilimumab

CX-072 in combination with anti-cancer therapy-Progressed

Experimental group

Description:

histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy

Treatment:

Drug: CX-072

CX-072 in combination with anti-cancer therapy-Neoadjuvant

Experimental group

Description:

neo-adjuvant study in subjects with histologically confirmed solid tumor

Treatment:

Drug: CX-072