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Metastatic Pancreatic CancerEarly Phase 1NCT04665947

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

A Early Phase 1 study testing [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. in people with Metastatic Pancreatic Cancer and Locally Advanced Pancreatic Adenocarcinoma, run by University of California, Davis at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
18 Dec 2020to 31 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • [68Ga]Ga DOTA-5G PET/CT Inclusion Criteria:
  • 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
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  • 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
  • Able to remain motionless for up to 30-60 minutes per scan
  • [177Lu]Lu DOTA-ABM-5G therapy Inclusion Criteria:
  • 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 lung or liver)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis

    Sacramento, California, 95817

Other trials in United States

About this study

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).

Read the detailed description

This is a Phase I, first-in-human study to evaluate the safety and efficacy of the [68Ga]Ga DOTA-5G /[177Lu]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). PET imaging using [68Ga]Ga DOTA-5G will be used to diagnose patients who are eligible for the [177Lu]Lu DOTA-ABM-5G. The overall purpose of this study is to identify the dose limiting toxicity (DLT) and recommended phase 2 dose (RP2D) of [177Lu]Lu DOTA-ABM-5G. A 3+3 study design in is proposed to identify the RP2D of [177Lu]Lu DOTA-ABM-5G. An expansion group will receive the RP2D in order to obtain initial estimates of response and additional information on safety of [177Lu]Lu DOTA-ABM-5G.

The hypotheses of this phase I study are that a) [68Ga]Ga DOTA-5G will detect lesions in patients with locally advanced or metastatic pancreas cancer b) the theranostic pair [68Ga]Ga DOTA-5G/ [177Lu]Lu DOTA-ABM-5G will be safe and well tolerated c) we will be able to identify a Recommended Phase 2 Dose (RP2D) for [177Lu]Lu DOTA-ABM-5G therapy to be used in subsequent Phase II trials.

Being tested
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Keywords
integrin, metastatic pancreatic cancer, PET, theranostic
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

    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.

Study groups in NCT04665947
Study groupRoleWhat they receive
[177Lu]Lu DOTA-ABM-5G dose escalation therapy studyExperimentalPatients 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.
Receives: Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy studyExperimentalPatients 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
Receives: Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [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

    Measured: 2 hours from time of injection

  2. [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

    Measured: 30 days from time of injection

Secondary outcomes (1)

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

    Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G using SPECT/CT imaging at various timepoints

    Measured: 7-14 days from time of injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start18 Dec 2020
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a first-in-human 3 + 3 study design to identify dose limiting toxicity and recommended phase 2 dose
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04665947
Sponsor's protocol ID
1667622
Status last verified
Sep 2026
First submitted
10 Dec 2020
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. in people with Metastatic Pancreatic Cancer and Locally Advanced Pancreatic Adenocarcinoma, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[68Ga]Ga DOTA-5G PET/CT imaging (time frame: 2 hours from time of injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04665947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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