## Protocol Section
### Identification Module
**NCT ID:** NCT06427369

**Brief Title:** An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer

**Official Title:** Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11

#### Organization Study ID Info
**ID:** I -1774023
#### Organization
**Class:** OTHER
**Full Name:** Roswell Park Cancer Institute
### Status Module
#### Completion Date
**Date:** 2027-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Roswell Park Cancer Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This phase I trial studies the side effects of 124I-hJAA-F11, and evaluates how well it works in diagnosing lung cancer. 124I-hJAA-F11 uses a known radioactive substance used in imaging called iodine 124 (124I). hJAA-F11 is an experimental (investigational) antibody that is currently being evaluated as a potential treatment for lung cancer. In animal studies, hJAA-F11 has shown anti-tumor activity against tumors bearing the Thomsen-Friedenreich antigen that is found in over 90% of lung cancers. 124I-hJAA-F11 has the 124I radioactive dye attached to this investigational antibody, which may be a potential tool for imaging-based diagnosis of lung cancer.

**Detailed Description:** PRIMARY OBJECTIVE:

I. To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer.

SECONDARY OBJECTIVES:

I. To assess the development of anti-drug antibodies following administration of 124I-hJAAF11.

II. To characterize concordance in lesions characterized by 124I-hJAA-F11-based positron emission tomography/computed tomography (PET/CT) compared to standard of care FDG (fluorodeoxyglucose)-PET.

III. To perform exploratory biomarker analyses based on conventional tissue and liquid-based platforms.

OUTLINE:

Patients receive 124I-hJAA-F11 intravenously (IV) on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial.

After completion of the study intervention, patients are followed up at day 8-14, weeks 4 and 8, and at 6 and 12 months.

### Conditions Module

**Conditions:**

- Extensive-stage Small-cell Lung Cancer

- Limited-stage Small-cell Lung Cancer

- Lung Non-Small Cell Carcinoma

- Stage IIIA Lung Cancer

- Stage IV Lung Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive 124I-hJAA-F11 IV on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial.

**Intervention Names:**

- Other: Radioconjugate

- Procedure: Positron Emission Tomography

- Procedure: Computed Tomography

- Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan

- Procedure: Biospecimen Collection

**Label:** Diagnostic

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diagnostic

**Description:** 1241-hJAA-F11 IV administration

**Name:** Radioconjugate

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Diagnostic

**Description:** PET/CT Imaging

**Name:** Positron Emission Tomography

**Other Names:**

- PET

- PET SCAN

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Diagnostic

**Description:** PET/CT Imaging

**Name:** Computed Tomography

**Other Names:**

- CAT

- CAT Scan

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- Diagnostic

**Description:** FDG PET/CT Imaging

**Name:** FDG-Positron Emission Tomography and Computed Tomography Scan

**Other Names:**

- FDG PET/CT

**Type:** PROCEDURE

#### Intervention 5

**Arm Group Labels:**

- Diagnostic

**Description:** Blood sample collection imaging

**Name:** Biospecimen Collection

**Other Names:**

- Biological Sample Collection

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0

**Measure:** Incidence of grade 3+ I-hJAA-F11 related adverse events

**Time Frame:** Up to 6 months after final PET/CT

**Description:** uptake values for tumor and normal organs will be measured and tumor to normal orgrans background ratios will be obtained.

**Measure:** Diagnostic efficacy of I-hJAA-F11

**Time Frame:** Within 30 days of final I/hJAA-f11 PET/CT

#### Secondary Outcomes

**Measure:** Development of anti-drug antibodies

**Time Frame:** Up to approximately 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with histologically or cytologically diagnosed small cell lung cancer (SCLC; either extensive stage or limited stage) or non-small cell lung cancer (NSCLC; at least clinical stage IIIA according to the American Joint Cancer Committee \[AJCC\] 8th edition)
* Patients undergoing FDG-PET scan as standard of care testing.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (exceptions allowed include patients on chronic antiviral or anti-bacterial medications without acute flares in the preceding 2 weeks), symptomatic congestive heart failure, unstable angina pectoris, Child-Pugh class C, dialysis-dependence, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing female participants

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Askrpci@roswellpark.org

**Name:** ASK RPCI

**Phone:** 1-877-275-7724

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Roswell Park Comprehensive Cancer Center

**Name:** Grace Dy, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Lung Non-Small Cell Carcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M28323

- Name: Small Cell Lung Carcinoma

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: T5271

- Name: Small Cell Lung Cancer

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000055752

- Term: Small Cell Lung Carcinoma

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Misc Info Module

- Version Holder: 2024-05-31
