Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas

NCT06389123 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 1788760
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.

Conditions

Metastatic Cancer

Keywords

integrin; PET; Theranostics; metastatic cancer

Outcome Measures

Primary Outcomes (1)

• [68Ga]Ga DOTA-5G PET/CT imaging

  To assess the ability of \[68Ga\]Ga DOTA-5G to detect lesions in patients with metastatic cancer

  2 hours from time of injection

Secondary Outcomes (2)

• [177Lu]Lu DOTA-ABM-5G treatment

  30 days from time of treatment

• [177Lu]Lu DOTA-ABM-5G treatment efficacy

  60 days from time of treatment

Study Arms (1)

[177Lu]Lu DOTA-ABM-5G single dose therapy study

EXPERIMENTAL

Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy.

Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Interventions

[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. DRUG

Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up \[68Ga\]Ga DOTA-5G PET/CT scans to assess tretament efficacy.

Also known as: [68Ga]Ga DOTA-5G, [177Lu]Lu DOTA-ABM-5G, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair

[177Lu]Lu DOTA-ABM-5G single dose therapy study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document.
• Age 18 or more years
• Pathologically confirmed GU, GI, GYN breast, cervical, uterine, or head and neck cancers with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis)
• Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging.
• Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
• Eastern Cooperative Oncology Group Performance Status ≤ 2
• Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to \[68Ga\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.
• Hematologic parameters defined as:
• Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
• Blood chemistry levels defined as:
• AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN 10. Anticipated life expectancy ≥ 3 months 11. Able to remain motionless for up to 30-60 minutes per scan
• Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan
• The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging)

You may not qualify if:

• Participants with Class 3 or 4 NYHA Congestive Heart Failure
• Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
• Pregnant or lactating women
• Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
• Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)
• Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
• Pathologically confirmed NSCLC with metastatic disease
• INR \>2.0: PTT\>15 seconds above ULN
• Participant on therapeutic warfarin anticoagulation
• External beam radiation therapy (EBRT) or radiopharmaceutical treatment within 21 days prior to study day 1

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of California, Davis: lead

Study Sites (1)

The University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie L Sutcliffe

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie L Sutcliffe, Phd

CONTACT

9167345536; jlsutcliffe@ucdavis.edu

Julie L Sutcliffe

CONTACT

9167345536; jlsutcliffe@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single treatment

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)