Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer (NCT NCT04467515)

NCT ID: NCT04467515

Last Updated: 2025-05-06

Results Overview

Dose-limiting toxicity (DLT) rate of CAM-H2 assessed by toxicities occurring within the first cycle

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Within the first cycle of CAM-H2, up to 12 weeks

Results posted on

2025-05-06

Participant Flow

The recruitment period began in September 2021 and ended in May 2023. The majority of patients were recruited from major hospitals.

Patient 203-001 (Cohort 3) passed screening but was withdrawn prior to being administered study drug due to an SAE.

Participant milestones

Participant milestones
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) Cohort 1: Patients will receive at least 1 cycle of CAM-H2 (2 x 1.85 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 2 CAM-H2 (2 x 3.7) GBq Cohort 2: Patients will receive at least 1 cycle of CAM-H2 (2 x 3.7 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 3 CAM-H2 (2 x 5.55) GBq Cohort 3: Patients will receive at least 1 cycle of CAM-H2 (2 x 5.55 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.
Overall Study STARTED	3	3	7
Overall Study COMPLETED	1	1	3
Overall Study NOT COMPLETED	2	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) Cohort 1: Patients will receive at least 1 cycle of CAM-H2 (2 x 1.85 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 2 CAM-H2 (2 x 3.7) GBq Cohort 2: Patients will receive at least 1 cycle of CAM-H2 (2 x 3.7 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 3 CAM-H2 (2 x 5.55) GBq Cohort 3: Patients will receive at least 1 cycle of CAM-H2 (2 x 5.55 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	1	0	1
Overall Study Progressive Disease	0	1	3
Overall Study Death	0	1	0

Baseline Characteristics

A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n=3 Participants Cohort 1: Patients will receive at least 1 cycle of CAM-H2 (2 x 1.85 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 2 CAM-H2 (2 x 3.7) GBq n=3 Participants Cohort 2: Patients will receive at least 1 cycle of CAM-H2 (2 x 3.7 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 3 CAM-H2 (2 x 5.55) GBq n=7 Participants Cohort 3: Patients will receive at least 1 cycle of CAM-H2 (2 x 5.55 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Canada	3 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	13 participants n=4 Participants
Weight	52.8 kg n=5 Participants	71.2 kg n=7 Participants	73.3 kg n=5 Participants	68.1 kg n=4 Participants
Baseline ECOG PS ECOG - 0	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants
Baseline ECOG PS ECOG - 1	1 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants	5 participants n=4 Participants
Cancer Type Breast	3 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants	9 participants n=4 Participants
Cancer Type Gastric	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Cancer Type GEJ	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Brain Metastases Status Yes	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Brain Metastases Status No	2 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	11 participants n=4 Participants

PRIMARY outcome

Timeframe: Within the first cycle of CAM-H2, up to 12 weeks

Population: Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle by patients

Dose-limiting toxicity (DLT) rate of CAM-H2 assessed by toxicities occurring within the first cycle

Outcome measures

Outcome measures
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 2 CAM-H2 (2 x 3.7) GBq n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 3 CAM-H2 (2 x 5.55) GBq n=7 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle
Dose-limiting Toxicity (DLT) Rate Within the First Cycle	0 DLTs	0 DLTs	1 DLTs

PRIMARY outcome

Timeframe: 18 months

Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Outcome measures

Outcome measures
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 2 CAM-H2 (2 x 3.7) GBq n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 3 CAM-H2 (2 x 5.55) GBq n=7 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs) Grade 3 - Severe	2 Adverse Events	3 Adverse Events	8 Adverse Events
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs) Grade 4 - Life-Threatening	0 Adverse Events	0 Adverse Events	0 Adverse Events
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs) Grade 5 - Death	0 Adverse Events	0 Adverse Events	0 Adverse Events
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs) Grade 1 - Mild	27 Adverse Events	24 Adverse Events	43 Adverse Events
Safety and Tolerability - Number of Treatment-emergent Adverse Events (TEAEs) Grade 2 - Moderate	7 Adverse Events	6 Adverse Events	22 Adverse Events

SECONDARY outcome

Timeframe: 18 months

Evaluate proportion of patients with a Complete Response, Partial Response, and Stable Disease in the dose escalation phase

Outcome measures

Outcome measures
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 2 CAM-H2 (2 x 3.7) GBq n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 3 CAM-H2 (2 x 5.55) GBq n=7 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle
To Assess the Clinical Benefit (CB) of CAM-H2 Stable Disease (SD)	1 Participants	0 Participants	2 Participants
To Assess the Clinical Benefit (CB) of CAM-H2 Progressive Disease (PD)	2 Participants	3 Participants	4 Participants
To Assess the Clinical Benefit (CB) of CAM-H2 Complete Response (CR)	0 Participants	0 Participants	0 Participants
To Assess the Clinical Benefit (CB) of CAM-H2 Partial Response (PR)	0 Participants	0 Participants	0 Participants
To Assess the Clinical Benefit (CB) of CAM-H2 Not Evaluable	0 Participants	0 Participants	0 Participants
To Assess the Clinical Benefit (CB) of CAM-H2 Not Applicable (NA) - Stable disease less than 8 weeks	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Number of patients on CAM-H2 who develop anti-drug antibodies (ADAs)

Percentage of patients on CAM-H2 who develop anti-drug antibodies (ADAs)

Outcome measures

Outcome measures
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 2 CAM-H2 (2 x 3.7) GBq n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 3 CAM-H2 (2 x 5.55) GBq n=7 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle
Anti-drug Antibodies (ADAs) Development	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 18 months

Thirteen patients in 3 different dose levels were evaluated. The total absorbed dose for the 3 source organs (kidneys, liver, red marrow)

Outcome measures

Outcome measures
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 2 CAM-H2 (2 x 3.7) GBq n=3 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle	Cohort 3 CAM-H2 (2 x 5.55) GBq n=7 Participants Any Dose-Limiting Toxicities (DLTs) that occur during the first cycle
Dosimetry Efficacy - Total Absorbed Dose Kidney	2.94 Gy Interval 2.05 to 3.47	4.68 Gy Interval 3.49 to 6.36	6.78 Gy Interval 1.45 to 11.27
Dosimetry Efficacy - Total Absorbed Dose Liver	0.84 Gy Interval 0.52 to 1.28	1.62 Gy Interval 1.39 to 2.07	3.65 Gy Interval 0.88 to 6.46
Dosimetry Efficacy - Total Absorbed Dose Red Marrow	0.30 Gy Interval 0.2 to 0.51	0.53 Gy Interval 0.42 to 0.6	0.95 Gy Interval 0.27 to 1.44

Adverse Events

Cohort 1 CAM-H2 (2 x 1.85 GBq)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2 CAM-H2 (2 x 3.7) GBq

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 3 CAM-H2 (2 x 5.55) GBq

Serious events: 1 serious events

Other events: 7 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 CAM-H2 (2 x 1.85 GBq) n=3 participants at risk Cohort 1: Patients will receive at least 1 cycle of CAM-H2 (2 x 1.85 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 2 CAM-H2 (2 x 3.7) GBq n=3 participants at risk Cohort 2: Patients will receive at least 1 cycle of CAM-H2 (2 x 3.7 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.	Cohort 3 CAM-H2 (2 x 5.55) GBq n=7 participants at risk Cohort 2: Patients will receive at least 1 cycle of CAM-H2 (2 x 5.55 GBq). Patients with CB may receive up to 4 cycles of CAM-H2, as long as the cumulative kidney dose remains \<23 Gy (based on the dosimetry results during Cycle 1). Cycles will be given as 2 IV administrations, 4 weeks apart.
Gastrointestinal disorders Colitis	0.00% 0/3 • Adverse events were monitored from time signing informed consent through study completion, an average of 18 months	33.3% 1/3 • Number of events 1 • Adverse events were monitored from time signing informed consent through study completion, an average of 18 months	0.00% 0/7 • Adverse events were monitored from time signing informed consent through study completion, an average of 18 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Adverse events were monitored from time signing informed consent through study completion, an average of 18 months	0.00% 0/3 • Adverse events were monitored from time signing informed consent through study completion, an average of 18 months	14.3% 1/7 • Number of events 1 • Adverse events were monitored from time signing informed consent through study completion, an average of 18 months

Other adverse events

Additional Information

Jonathan Delara, Clinical Trial Manager

Precirix

Phone: +1 (512) 589-2114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60