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

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Solid Tumor; Unresectable or Metastatic Melanoma
• Interventions: Drug: CX-072; Drug: Ipilimumab
• Enrollment: 3

Participant Flow

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

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description	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	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	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	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
Period Title: Overall Study
Started	0	3	0	0
Completed	0 [1]	0 [2]	0 [1]	0 [1]
Not Completed	0	3	0	0
Reason Not Completed
The study was terminated early due to business decision.	0	2	0	0
Withdrawal by Subject	0	1	0	0
[1] No subjects enrolled in this arm/group.; [2] Subjects did not complete due to early termination of the study due to business reasons.

Baseline Characteristics

Arm/Group Title		Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant	Total
Arm/Group Description		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	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	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	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 of all reporting groups
Overall Number of Baseline Participants		0	3	0	0	3
Baseline Analysis Population Description		Due to the early study termination, a statistical analysis plan was not generated. The statistical analyses per the study protocol were not performed due to insufficient sample size and the efficacy and pharmacokinetic analyses were not performed.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	3 participants	0 participants	0 participants	3 participants
	<=18 years	0	0 0.0%	0	0	0 0.0%
	Between 18 and 65 years	0	1 33.3%	0	0	1 33.3%
	>=65 years	0	2 66.7%	0	0	2 66.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	3 participants	0 participants	0 participants	3 participants
	Female	0	1 33.3%	0	0	1 33.3%
	Male	0	2 66.7%	0	0	2 66.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	3 participants	0 participants	0 participants	3 participants
	American Indian or Alaska Native		0 0.0%			0 0.0%
	Asian		1 33.3%			1 33.3%
	Native Hawaiian or Other Pacific Islander		0 0.0%			0 0.0%
	Black or African American		0 0.0%			0 0.0%
	White		2 66.7%			2 66.7%
	More than one race		0 0.0%			0 0.0%
	Unknown or Not Reported		0 0.0%			0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	0 participants	3 participants	0 participants	0 participants	3 participants
Netherlands			0			0
South Korea			0			0
United States			3			3
Australia			0			0
Spain			0			0

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate by RECIST v 1.1
Description	ORR by RECIST v1.1
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description:	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	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	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	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 Number of Participants Analyzed	0	2	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response (CR)	0	0 0.0%	0	0
Partial Response (PR)	0	0 0.0%	0	0
Stable Disease (SD)	0	0 0.0%	0	0
Progressive Disease (PD)	0	2 100.0%	0	0

2. Secondary Outcome

Title	The Percentage of Patients Experiencing Treatment Related Adverse Events
Description	Safety and Tolerability of CX-072 in Combination Therapy
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

All subjects who receive any amount of CX-072.

Arm/Group Title		Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description:		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	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	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	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 Number of Participants Analyzed		0	3	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
Gastrointestinal disorders - Diarrhea (treatment related)	Experienced	0	1 33.3%	0	0
	Did not experience	0	2 66.7%	0	0
Hepatobiliary Disorders - Immune-mediated Hepatitis (treatment related)	Experienced	0	2 66.7%	0	0
	Did not experience	0	1 33.3%	0	0
Gastrointestinal disorders - Vomitting (treatment related)	Experienced	0	1 33.3%	0	0
	Did not experience	0	2 66.7%	0	0
Metabolism and nutrition disorders - Dehydration (treatment related)	Experienced	0	1 33.3%	0	0
	Did not experience	0	2 66.7%	0	0
Skin and subcutaneous tissuedisorders - Rash Generalized (treatment related)	Experienced	0	1 33.3%	0	0
	Did not experience	0	2 66.7%	0	0
Injury, poisoning and proceduralcomplications - Infusion Related Reaction	Experienced	0	1 33.3%	0	0
	Did not experience	0	2 66.7%	0	0

3. Secondary Outcome

Title	The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST
Description	ORR by irRECIST
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description:	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	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	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	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 Number of Participants Analyzed	0	2	0	0
Measure Type: Count of Participants; Unit of Measure: Participants
immune-related Complete Response (irCR)	0	0 0.0%	0	0
immune-related Partial Response (irPR)	0	0 0.0%	0	0
immune-related Stable Disease (irSD)	0	0 0.0%	0	0
immune-related Progressive Disease (irPD)	0	2 100.0%	0	0
no target disease identified at baseline and at follow-up (irNN)	0	0 0.0%	0	0

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	All AEs are reported from signing of the informed consent through study completion, regardless of attribution/causality.
Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description	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		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		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		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
All-Cause Mortality
	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/0		0/3 (0.00%)		0/0		0/0
Serious Adverse Events
	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0		1/3 (33.33%)		0/0		0/0
Hepatobiliary disorders
Immune-mediated Hepatitis †	0/0		1/3 (33.33%)		0/0		0/0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0		3/3 (100.00%)		0/0		0/0
Gastrointestinal disorders
Diarrhea †	0/0		1/3 (33.33%)	1	0/0		0/0
Nausea †	0/0		1/3 (33.33%)	1	0/0		0/0
Vomitting †	0/0		1/3 (33.33%)	1	0/0		0/0
General disorders
Generalized Oedema †	0/0		1/3 (33.33%)	1	0/0		0/0
Oedema Peripheral †	0/0		1/3 (33.33%)	1	0/0		0/0
Hepatobiliary disorders
Immune-mediated Hepatitis †	0/0		2/3 (66.67%)	2	0/0		0/0
Infections and infestations
Cellulitis †	0/0		1/3 (33.33%)	1	0/0		0/0
Injury, poisoning and procedural complications
Infusion Related Reaction †	0/0		1/3 (33.33%)	2	0/0		0/0
Investigations
Blood Creatinine Increased †	0/0		1/3 (33.33%)	1	0/0		0/0
Metabolism and nutrition disorders
Dehydration †	0/0		1/3 (33.33%)	2	0/0		0/0
Hypokalemia †	0/0		1/3 (33.33%)	1	0/0		0/0
Hypophosphataemia †	0/0		1/3 (33.33%)	1	0/0		0/0
Hyperglycaemia †	0/0		1/3 (33.33%)	1	0/0		0/0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain †	0/0		1/3 (33.33%)	1	0/0		0/0
Skin and subcutaneous tissue disorders
Rash Generalized †	0/0		1/3 (33.33%)	1	0/0		0/0
Pruritus †	0/0		1/3 (33.33%)	1	0/0		0/0
† Indicates events were collected by systematic assessment

Limitations and Caveats

Due to developmental strategic reasons and slow enrollment because of the COVID-19 pandemic, the study was terminated early. Three subjects were enrolled, all in Cohort A2. The last subject observation for this study was on 21 May 2020. Since the study terminated early, a statistical analysis plan was not generated.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

 

Results Point of Contact

• Name/Title: Lawrence Lu
• Organization: CytomX Therapeutics
• Phone: (650) 515-3185
• EMail: clinicaltrials@cytomx.com

• Responsible Party: CytomX Therapeutics
• ClinicalTrials.gov Identifier: NCT03993379
• Other Study ID Numbers: CTMX-M-072-002
• First Submitted: May 14, 2019
• First Posted: June 20, 2019
• Results First Submitted: September 2, 2021
• Results First Posted: December 1, 2021
• Last Update Posted: December 1, 2021