Trial Outcomes & Findings for PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors (NCT NCT03993379)

NCT ID: NCT03993379

Last Updated: 2025-12-26

Results Overview

ORR by RECIST v1.1

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

1 year

Results posted on

2025-12-26

Participant Flow

This study was composed of 2 parts (Part A and Part B) and 4 cohorts (A1, A2, A3, B1).

Subjects who meet Inclusion / Exclusion criteria began the Screening Period within 30 days prior to the first dose of study treatment. Subjects for whom consent was provided underwent Screening Period assessments to determine eligibility for the study; assessments were to be performed within 30 days prior to the first dose of study treatment.

Participant milestones

Participant milestones
Measure	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A2: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A3: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: * Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w
Overall Study STARTED	0	3	0	0
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	0	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A2: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A3: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: * Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w
Overall Study The study was terminated early due to business decision.	0	2	0	0
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A2: CX-072 in Combination With Ipilimumab n=3 Participants 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 ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A3: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: * Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants	1 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants	1 Participants n=880 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	2 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants	2 Participants n=880 Participants
Sex: Female, Male Female	0 Participants n=30 Participants	1 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants	1 Participants n=880 Participants
Sex: Female, Male Male	0 Participants n=30 Participants	2 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants	2 Participants n=880 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=30 Participants	—	—	0 Participants n=880 Participants
Race (NIH/OMB) Asian	—	1 Participants n=30 Participants	—	—	1 Participants n=880 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=30 Participants	—	—	0 Participants n=880 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=30 Participants	—	—	0 Participants n=880 Participants
Race (NIH/OMB) White	—	2 Participants n=30 Participants	—	—	2 Participants n=880 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=30 Participants	—	—	0 Participants n=880 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=30 Participants	—	—	0 Participants n=880 Participants
Region of Enrollment Netherlands	—	0 participants n=30 Participants	—	—	0 participants n=880 Participants
Region of Enrollment South Korea	—	0 participants n=30 Participants	—	—	0 participants n=880 Participants
Region of Enrollment United States	—	3 participants n=30 Participants	—	—	3 participants n=880 Participants
Region of Enrollment Australia	—	0 participants n=30 Participants	—	—	0 participants n=880 Participants
Region of Enrollment Spain	—	0 participants n=30 Participants	—	—	0 participants n=880 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All subjects who have at least one measurable lesion at baseline, receive at least 1 infusion of CX-072 DP and have at least 1 postbaseline RECIST 1.1 assessment, or who discontinue treatment/study due to disease progression by RECIST v 1.1.

ORR by RECIST v1.1

Outcome measures

Outcome measures
Measure	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A2: CX-072 in Combination With Ipilimumab n=2 Participants 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 ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A3: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: * Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w
Overall Response Rate by RECIST v 1.1 Progressive Disease (PD)	0 Participants	2 Participants	0 Participants	0 Participants
Overall Response Rate by RECIST v 1.1 Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response Rate by RECIST v 1.1 Partial Response (PR)	0 Participants	0 Participants	0 Participants	0 Participants
Overall Response Rate by RECIST v 1.1 Stable Disease (SD)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: All subjects who receive any amount of CX-072.

Safety and Tolerability of CX-072 in Combination Therapy

Outcome measures

Outcome measures
Measure	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A2: CX-072 in Combination With Ipilimumab n=3 Participants 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 ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A3: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: * Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w
The Percentage of Patients Experiencing Treatment Related Adverse Events Hepatobiliary Disorders - Immune-mediated Hepatitis (treatment related) · Did not experience	0 Participants	1 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Gastrointestinal disorders - Vomitting (treatment related) · Experienced	0 Participants	1 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Gastrointestinal disorders - Vomitting (treatment related) · Did not experience	0 Participants	2 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Metabolism and nutrition disorders - Dehydration (treatment related) · Experienced	0 Participants	1 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Metabolism and nutrition disorders - Dehydration (treatment related) · Did not experience	0 Participants	2 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Skin and subcutaneous tissuedisorders - Rash Generalized (treatment related) · Experienced	0 Participants	1 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Skin and subcutaneous tissuedisorders - Rash Generalized (treatment related) · Did not experience	0 Participants	2 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Injury, poisoning and proceduralcomplications - Infusion Related Reaction · Experienced	0 Participants	1 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Injury, poisoning and proceduralcomplications - Infusion Related Reaction · Did not experience	0 Participants	2 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Gastrointestinal disorders - Diarrhea (treatment related) · Experienced	0 Participants	1 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Gastrointestinal disorders - Diarrhea (treatment related) · Did not experience	0 Participants	2 Participants	0 Participants	0 Participants
The Percentage of Patients Experiencing Treatment Related Adverse Events Hepatobiliary Disorders - Immune-mediated Hepatitis (treatment related) · Experienced	0 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: All subjects who have at least one measurable lesion at baseline, receive at least 1 infusion of CX-072 DP and have at least 1 postbaseline irRECIST assessment, or who discontinue treatment/study due to disease progression by irRECIST.

ORR by irRECIST

Outcome measures

Outcome measures
Measure	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A2: CX-072 in Combination With Ipilimumab n=2 Participants 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 ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A3: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: * Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST immune-related Complete Response (irCR)	0 Participants	0 Participants	0 Participants	0 Participants
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST immune-related Partial Response (irPR)	0 Participants	0 Participants	0 Participants	0 Participants
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST immune-related Stable Disease (irSD)	0 Participants	0 Participants	0 Participants	0 Participants
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST immune-related Progressive Disease (irPD)	0 Participants	2 Participants	0 Participants	0 Participants
The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST no target disease identified at baseline and at follow-up (irNN)	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort A2: CX-072 in Combination With Ipilimumab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A2: CX-072 in Combination With Ipilimumab n=3 participants at risk 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 ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort A3: 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 CX-072 in combination with ipilimumab Part A Dosing Regimen: * Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: * Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w * Monotherapy treatment: 800 mg CX-072, q2w
Hepatobiliary disorders Immune-mediated Hepatitis	— 0/0 • The pre-specified AE reporting period spans from signing of the ICF to 30 days after the last dose. Monitoring continued for immune-related AEs, AEs ≥ Grade 3, and serious AEs (SAEs) up to 90 days following the last dose of the study drug. All AEs are reported from signing of the informed consent through study completion, an average of 4 months. All AEs are reported from signing of the informed consent through study completion, regardless of attribution/causality.	33.3% 1/3 • The pre-specified AE reporting period spans from signing of the ICF to 30 days after the last dose. Monitoring continued for immune-related AEs, AEs ≥ Grade 3, and serious AEs (SAEs) up to 90 days following the last dose of the study drug. All AEs are reported from signing of the informed consent through study completion, an average of 4 months. All AEs are reported from signing of the informed consent through study completion, regardless of attribution/causality.	— 0/0 • The pre-specified AE reporting period spans from signing of the ICF to 30 days after the last dose. Monitoring continued for immune-related AEs, AEs ≥ Grade 3, and serious AEs (SAEs) up to 90 days following the last dose of the study drug. All AEs are reported from signing of the informed consent through study completion, an average of 4 months. All AEs are reported from signing of the informed consent through study completion, regardless of attribution/causality.	— 0/0 • The pre-specified AE reporting period spans from signing of the ICF to 30 days after the last dose. Monitoring continued for immune-related AEs, AEs ≥ Grade 3, and serious AEs (SAEs) up to 90 days following the last dose of the study drug. All AEs are reported from signing of the informed consent through study completion, an average of 4 months. All AEs are reported from signing of the informed consent through study completion, regardless of attribution/causality.

Other adverse events

Additional Information

Lawrence Lu

CytomX Therapeutics

Phone: (650) 515-3185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER