Lymphoma, Solid Tumor
Conditions
Keywords
cancer, checkpoint inhibitor, monotherapy, combination, PD-L1, CTLA-4, solid tumor, lymphoma, BRAF, PROCLAIM, CX-072, PROCLAIM-CX-072
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 U.S. registered trademark of CytomX Therapeutics, Inc.
Interventions
Sponsors
CytomX Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy 2. Agreement to provide mandatory archival tissue or fresh biopsy. 3. At least 18 years of age.
Exclusion criteria
1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen. 2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic. 3. 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. 4. 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. 5. History of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications. 6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant. 7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) 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) | Adverse events (AEs) that were considered DLTs: * Grade 5 AEs * Grade 4 AEs judged by the Investigator to be treatment-related or judged by the Sponsor as a DLT, regardless of Investigator-attribution (with some exceptions) • Any Grade 4 endocrinopathy. * Grade 3 AEs judged by the Investigator to be treatment-related or by the Sponsor, regardless of Investigator-attribution (with some exceptions) • Any Grade 3 central nervous system event, regardless of duration or reversibility. * Grade 2 pneumonitis necessitating CX-072 discontinuation * Grade 2 ocular toxicity necessitating CX-072 discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy | 2 years | The primary efficacy endpoint, ORR, was defined as the proportion of subjects with complete response (CR) or partial response (PR) on two consecutive tumor assessments according to RECIST v1.1. |
Countries
Netherlands, Poland, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
A total of 278 patients were screened for the study, and 196 patients received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| CX-072 0.03 mg/kg (Part A and Part A2) Monotherapy CX-072 0.03 mg/kg (Part A and Part A2)
CX-072: Solution for infusion | 2 |
| CX-072 0.1 mg/kg (Part A and Part A2) Monotherapy CX-072 0.1 mg/kg (Part A and Part A2)
CX-072: Solution for infusion | 2 |
| CX-072 0.3 mg/kg (Part A and Part A2) Monotherapy CX-072 0.3 mg/kg (Part A and Part A2)
CX-072: Solution for infusion | 8 |
| CX-072 1 mg/kg (Part A and Part A2) Monotherapy CX-072 1 mg/kg (Part A and Part A2)
CX-072: Solution for infusion | 9 |
| CX-072 3 mg/kg (Part A and Part A2) Monotherapy CX-072 3 mg/kg (Part A and Part A2)
CX-072: Solution for infusion | 13 |
| CX-072 10 mg/kg (Part A and Part A2) Monotherapy CX-072 10 mg/kg (Part A and Part A2)
CX-072: Solution for infusion | 16 |
| CX-072 30 mg/kg (Part A and Part A2) Monotherapy CX-072 30 mg/kg (Part A and Part A2)
CX-072: Solution for infusion | 3 |
| CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 0.3 mg/kg + ipilimumab 3 mg/kg (Part B1)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 6 |
| CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 1 mg/kg + ipilimumab 3 mg/kg (Part B1)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 3 |
| CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B1)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 3 |
| CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 3 mg/kg (Part B1)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 8 |
| CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 6 mg/kg (Part B1)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 6 |
| CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) Combination CX-072 10 mg/kg + ipilimumab 10 mg/kg (Part B1)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 1 |
| CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 6 |
| CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) Combination CX-072 3 mg/kg + ipilimumab 3 mg/kg (Part B2)
CX-072: Solution for infusion
Ipilimumab: Solution for infusion | 1 |
| CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 1 mg/kg + Vemurafenib 960 mg (Part C)
CX-072: Solution for infusion
Vemurafenib: Tablet | 3 |
| CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 3 mg/kg + Vemurafenib 960 mg (Part C)
CX-072: Solution for infusion
Vemurafenib: Tablet | 6 |
| CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) Combination CX-072 10 mg/kg + Vemurafenib 960 mg (Part C)
CX-072: Solution for infusion
Vemurafenib: Tablet | 2 |
| CX-072 10 mg/kg (Part D) Monotherapy CX-072 10 mg/kg expansion (Part D) | 98 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Long-term Extension | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Long-term Extension | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Long-term Extension | Disease progression | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Long-term Extension | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Main Study | Death | 2 | 2 | 5 | 3 | 9 | 12 | 3 | 5 | 1 | 2 | 4 | 1 | 1 | 4 | 0 | 3 | 5 | 1 | 47 |
| Main Study | Disease progression | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| Main Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Main Study | Partial withdrawal with survival follow-up only | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Main Study | Protocol version 8.0 approval | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Main Study | Start of new anticancer therapy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Main Study | Symptomatic deterioration | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Main Study | Termination of the study by Sponsor | 0 | 0 | 2 | 0 | 1 | 2 | 0 | 0 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 13 |
| Main Study | Withdrawal by Subject | 0 | 0 | 0 | 4 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 18 |
Baseline characteristics
| Characteristic | CX-072 0.03 mg/kg (Part A and Part A2) | CX-072 0.1 mg/kg (Part A and Part A2) | CX-072 0.3 mg/kg (Part A and Part A2) | CX-072 1 mg/kg (Part A and Part A2) | CX-072 3 mg/kg (Part A and Part A2) | CX-072 10 mg/kg (Part A and Part A2) | CX-072 30 mg/kg (Part A and Part A2) | CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) | CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) | CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) | CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) | CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) | CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) | CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) | CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) | CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) | CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) | CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) | CX-072 10 mg/kg (Part D) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.5 Years STANDARD_DEVIATION 2.12 | 72.0 Years STANDARD_DEVIATION 2.83 | 60.8 Years STANDARD_DEVIATION 9.88 | 59.2 Years STANDARD_DEVIATION 9.43 | 63.3 Years STANDARD_DEVIATION 15.12 | 55.3 Years STANDARD_DEVIATION 13.11 | 58.0 Years STANDARD_DEVIATION 10.44 | 56.5 Years STANDARD_DEVIATION 16.94 | 38.0 Years STANDARD_DEVIATION 1.73 | 53.0 Years STANDARD_DEVIATION 8.72 | 53.9 Years STANDARD_DEVIATION 9.14 | 51.8 Years STANDARD_DEVIATION 10.19 | 67.0 Years | 56.7 Years STANDARD_DEVIATION 8.38 | 40 Years | 47.3 Years STANDARD_DEVIATION 17.24 | 46.3 Years STANDARD_DEVIATION 20.88 | 53.5 Years STANDARD_DEVIATION 9.19 | 59.9 Years STANDARD_DEVIATION 12.28 | 58.1 Years STANDARD_DEVIATION 12.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 6 Participants | 7 Participants | 10 Participants | 14 Participants | 2 Participants | 6 Participants | 2 Participants | 3 Participants | 6 Participants | 4 Participants | 1 Participants | 6 Participants | 1 Participants | 3 Participants | 6 Participants | 2 Participants | 70 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 21 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 20 Participants | 31 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 6 Participants | 7 Participants | 10 Participants | 15 Participants | 2 Participants | 6 Participants | 2 Participants | 2 Participants | 5 Participants | 5 Participants | 1 Participants | 5 Participants | 1 Participants | 3 Participants | 6 Participants | 1 Participants | 67 Participants | 148 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 4 Participants | 3 Participants | 8 Participants | 9 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 6 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 60 Participants | 116 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 4 Participants | 6 Participants | 5 Participants | 7 Participants | 2 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 38 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 2 | 2 / 2 | 5 / 8 | 4 / 9 | 9 / 13 | 13 / 16 | 3 / 3 | 5 / 6 | 2 / 3 | 2 / 3 | 4 / 8 | 1 / 6 | 1 / 1 | 4 / 6 | 0 / 1 | 3 / 3 | 5 / 6 | 1 / 2 | 50 / 98 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 8 / 8 | 9 / 9 | 13 / 13 | 16 / 16 | 3 / 3 | 6 / 6 | 3 / 3 | 3 / 3 | 7 / 8 | 6 / 6 | 1 / 1 | 6 / 6 | 1 / 1 | 3 / 3 | 6 / 6 | 2 / 2 | 94 / 98 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 3 / 8 | 3 / 9 | 7 / 13 | 8 / 16 | 0 / 3 | 3 / 6 | 3 / 3 | 0 / 3 | 4 / 8 | 3 / 6 | 0 / 1 | 3 / 6 | 0 / 1 | 2 / 3 | 5 / 6 | 1 / 2 | 33 / 98 |
Outcome results
Primary
The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib
Adverse events (AEs) that were considered DLTs: * Grade 5 AEs * Grade 4 AEs judged by the Investigator to be treatment-related or judged by the Sponsor as a DLT, regardless of Investigator-attribution (with some exceptions) • Any Grade 4 endocrinopathy. * Grade 3 AEs judged by the Investigator to be treatment-related or by the Sponsor, regardless of Investigator-attribution (with some exceptions) • Any Grade 3 central nervous system event, regardless of duration or reversibility. * Grade 2 pneumonitis necessitating CX-072 discontinuation * Grade 2 ocular toxicity necessitating CX-072 discontinuation
Time frame: 28 days (dose limiting toxicity period)
Population: The safety analysis population includes all enrolled subjects who receive at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CX-072 0.03 mg/kg (Part A and Part A2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 0.1 mg/kg (Part A and Part A2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 0.3 mg/kg (Part A and Part A2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 1 mg/kg (Part A and A2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 1 Participants |
| CX-072 3 mg/kg (Part A and Part A2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 1 Participants |
| CX-072 10 mg/kg (Part A and Part A2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 30 mg/kg (Part A and Part A2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 0.3 mg/kg + Ipilimumab 3 mg/kg (Part B1) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 1 Participants |
| CX-072 1 mg/kg + Ipilimumab 3 mg/kg (Part B1) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B1) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B1) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 10 mg/kg + Ipilimumab 6 mg/kg (Part B1) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 2 Participants |
| CX-072 10 mg/kg + Ipilimumab 10 mg/kg (Part B1) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 3 mg/kg + Ipilimumab 3 mg/kg (Part B2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 10 mg/kg + Ipilimumab 3 mg/kg (Part B2) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 1 mg/kg + Vemurafenib 960 mg (Part C) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 3 mg/kg + Vemurafenib 960 mg (Part C) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
| CX-072 10 mg/kg + Vemurafenib 960 mg (Part C) | The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib | 0 Participants |
Secondary
The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy
The primary efficacy endpoint, ORR, was defined as the proportion of subjects with complete response (CR) or partial response (PR) on two consecutive tumor assessments according to RECIST v1.1.
Time frame: 2 years
Population: Per CX-072-001 Statistical Analysis Plan, efficacy analyses will be limited to subjects who received 10 mg/kg CX-072 as monotherapy during the study. This efficacy subset includes subjects from Parts A, A2 and D. Efficacy summaries will have parts A and A2 combined
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CX-072 0.03 mg/kg (Part A and Part A2) | The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy | 1 Participants |
| CX-072 0.1 mg/kg (Part A and Part A2) | The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy | 13 Participants |