Clinical trial · Interventional

Imaging of Solid Tumors Using DLL3 SPECT

NCT07052760CI-TRIAL-00109765withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Sponsor funding

Summary

Brief summary (as posted)

This is a single arm, pilot trial that evaluates the ability of a novel imaging agent (111In-ABD147) to detect metastatic cancer in participants with solid tumors. 111In-ABD147 is a high affinity Delta-like ligand 3 (DLL3) antigen binding domain fused to an engineered humanized Fc to create an antibody (VHH-Fc) that is bio-conjugated with a DOTA linker-chelator to a 111In radiometal. DLL3 is expressed on a variety of tumors, particularly those with neuroendocrine features.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Castration Resistant Prostate Cancer	Castration-Resistant Prostate Carcinoma	ALIAS	0.90
Castration Resistant Prostate Cancer (CRPC)	Castration-Resistant Prostate Carcinoma	ALIAS	0.85
Neuroendocrine (NE) Tumors	—	UNRESOLVED	—
Solid Tumor Cancer	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
111In-ABD147	Drug	—	UNRESOLVED
Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Cohort 1: Castration resistant prostate cancer
description
Participants will receive a single administration of 185 megabecquerels (MBq) (5 millicurie (mCi)) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
interventionNames
1. Drug: 111In-ABD147
2. Procedure: Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
type
EXPERIMENTAL
label
Cohort 2: High grade neuroendocrine tumor
description
Participants will receive a single administration of 185 MBq (5 mCi) +/- 10% of 111In-ABD147 prior to SPECT/CT imaging 48 hours after injection. Repeat administration of 111In-ABD147 and SPECT/CT imaging may be performed. Participants will be followed for up to 7 days after the injection of 111In-ABD147 for evaluation of adverse events.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age ≥ 18 years
2. Histopathologically confirmed solid tumors in one of the following cohorts:

   1. Cohort 1 (n=15): Histologically confirmed prostate cancer, with castration resistant disease per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.
   2. Cohort 2 (n=15): Histologically confirmed high grade neuroendocrine tumor, with a Ki-67 over 20.
   3. Cohort 3 (n=15): Agnostic to tumor type.
3. Metastatic disease present on conventional imaging defined as having Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease or multiple bone metastases.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
2. Has known hypersensitivity to Chinese hamster ovary cell products.
3. Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
4. Known pregnancy.

References

Publications (0)

Data not yet available

No reference posted for this study.