First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer

NCT04665947 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 1667622
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, first-in-human study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreatic adenocarcinoma (PDAC).

Conditions

Metastatic Pancreatic Cancer; Locally Advanced Pancreatic Adenocarcinoma

Keywords

integrin; metastatic pancreatic cancer; PET; theranostic

Outcome Measures

Primary Outcomes (2)

• [68Ga]Ga DOTA-5G PET/CT imaging

  Assessment of \[68Ga\]Ga DOTA-5G PET/CT imaging to detect lesions in patients with locally advanced or metastatic pancreatic cancer

  2 hours from time of injection

• [177Lu]Lu DOTA-ABM-5G dose escalation therapy

  Frequency of dose-limiting toxicities (DLT) of \[177Lu\]Lu DOTA-ABM-5G at escalating dose levels of \[177Lu\]Lu DOTA-ABM-5G

  30 days from time of injection

Secondary Outcomes (1)

• Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G

  7-14 days from time of injection

Study Arms (2)

[177Lu]Lu DOTA-ABM-5G dose escalation 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. Escalating doses of 25-200 mCi of \[177Lu\]Lu DOTA-ABM-5G will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.

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

Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G 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.10 patients will be enrolled in the dose expansion cohort and recieve the highest dose achieved in the \[177Lu\]Lu DOTA-ABM-5G dose escalation therapy study

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

Interventions

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

PET imaging using \[68Ga\]Ga DOTA-5G will be used to diagnose patients who are eligible for treatment with the \[177Lu\]Lu DOTA-ABM-5G.

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

Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy study; [177Lu]Lu DOTA-ABM-5G dose escalation 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
• Confirmed presence of locally advanced, unresectable or metastatic pancreatic adenocarcinoma (other pancreatic malignant histologies are excluded) with 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 during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment
• Eastern Cooperative Oncology Group Performance Status ≤ 2
• Participant must have completed prior chemotherapy 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
• Anticipated life expectancy ≥ 3 months

You may not qualify if:

• Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
• 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
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Previous radiation therapy for the treatment of advanced or metastatic disease
• Cannot undergo PET/CT scanning because of weight limits (350 lbs)
• INR\>1.2; PTT\>5 seconds above UNL

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Julie L Sutcliffe

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie L Sutcliffe

CONTACT

916-734-5536; jlsutcliffe@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a first-in-human 3 + 3 study design to identify dose limiting toxicity and recommended phase 2 dose

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 14, 2020
• Study Start: December 18, 2020
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)