Trial Outcomes & Findings for Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2) (NCT NCT03773133)
NCT ID: NCT03773133
Last Updated: 2022-09-13
Results Overview
TERMINATED
PHASE1/PHASE2
9 participants
From Day 1 (first administration of 177Lu-satoreotide tetraxetan) up to 6 weeks after the second administration; no longer applicable due to early study termination.
2022-09-13
Participant Flow
This phase I/II, multicenter, open-label single-arm study of 177Lu-satoreotide tetraxetan therapy with companion diagnostic imaging Gallium-68 (68Ga)-satoreotide trizoxetan (formerly 68Ga-OPS202) positron emission tomography (PET)/computed tomography (CT) was terminated early on 20 November 2019 due to unsuccessful screening.
Overall, 9 subjects were enrolled of which 8 received the screening investigational imaging product (IIP) 68Ga-satoreotide trizoxetan and 1 did not due to consent withdrawn by subject. None of the subjects received the therapeutic investigational radiopharmaceutical product (IRPP), 177Lu-satoreotide tetraxetan.
Participant milestones
| Measure |
Screened Subjects
In the screening period, 8 subjects received a single intravenous (i.v.) injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 micrograms (ug) and a radioactivity dose range of 150-200 Megabequerel (MBq) for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
Received the Screening IIP
|
8
|
|
Overall Study
Received the Therapeutic IRPP
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Screened Subjects
In the screening period, 8 subjects received a single intravenous (i.v.) injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 micrograms (ug) and a radioactivity dose range of 150-200 Megabequerel (MBq) for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.
|
|---|---|
|
Overall Study
Screen Failure
|
8
|
Baseline Characteristics
Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)
Baseline characteristics by cohort
| Measure |
Screened Subjects
n=8 Participants
In the screening period, 8 subjects received a single i.v. injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 ug and a radioactivity dose range of 150-200 MBq for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (first administration of 177Lu-satoreotide tetraxetan) up to 6 weeks after the second administration; no longer applicable due to early study termination.Population: No efficacy data was collected since none of the subjects received the IRPP, 177Lu-satoreotide tetraxetan.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 weeks after each administration of 177Lu-satoreotide tetraxetan during the core study or at occurrence of first clinical signs of disease progression as determined by the investigator, up to 90 days; no longer applicable due to early study termination.Population: No efficacy data was collected since none of the subjects received the IRPP, 177Lu-satoreotide tetraxetan.
Outcome measures
Outcome data not reported
Adverse Events
68Ga-satoreotide Trizoxetan Safety Population
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
68Ga-satoreotide Trizoxetan Safety Population
n=8 participants at risk
The 68Ga-satoreotide trizoxetan safety population included all subjects who received at least 1 dose of 68Ga-satoreotide trizoxetan.
|
|---|---|
|
Immune system disorders
Iodine allergy
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events were assessed after first administration of the IIP, 68Ga-satoreotide trizoxetan, until the data cut-off for study termination (maximum of 21 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place