Recruiting
Early Phase 1

[68Ga]Ga DOTA-5G & [177Lu]Lu DOTA-ABM-5G

Sponsor:

UCLA

Code:

NCT04665947

Conditions

Metastatic Pancreatic Cancer

Locally Advanced Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT04665947

Start date

Dec 18, 2020

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

\[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.
2. Age 18 or more years
3. 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)
4. 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
5. Eastern Cooperative Oncology Group Performance Status ≤ 2
6. 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.
7. Hematologic parameters defined as:

1. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
2. Platelet count ≥ 100,000/mm3
3. Hemoglobin ≥ 8 g/dL
8. Blood chemistry levels defined as:

1. AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
2. Total bilirubin ≤ 2 times ULN
3. Creatinine ≤ 2 times ULN
9. Anticipated life expectancy ≥ 3 months
10. Able to remain motionless for up to 30-60 minutes per scan

\[177Lu\]Lu DOTA-ABM-5G therapy Inclusion Criteria:

1. Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan
2. The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal lung or liver)

Exclusion Criteria:

  • \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy Exclusion Criteria:

1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
2. Participants with Class 3 or 4 NYHA Congestive Heart Failure
3. Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
4. Pregnant or lactating women
5. 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
6. Has an additional active malignancy requiring therapy within the past 2 years
7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
8. Psychiatric illness/social situations that would interfere with compliance with study requirements
9. Previous radiation therapy for the treatment of advanced or metastatic disease
10. Cannot undergo PET/CT scanning because of weight limits (350 lbs)
11. INR>1.2; PTT>5 seconds above UNL

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: [177Lu]Lu DOTA-ABM-5G dose escalation therapy study

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.

experimental: Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy study

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

Interventions

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

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.

Primary outcome measure

  • [68Ga]Ga DOTA-5G PET/CT imaging [ Time Frame: 2 hours from time of injection ]
  • [177Lu]Lu DOTA-ABM-5G dose escalation therapy [ Time Frame: 30 days from time of injection ]

Central Contacts and Locations

Central contacts

Locations

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Principal Investigator:

Julie Sutcliffe

More Information

Sponsor

University of California, Davis

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • integrin
  • metastatic pancreatic cancer
  • PET
  • theranostic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-04-29.