DOTA-5G Pair for Pancreatic Cancer

Overseen By Julie Sutcliffe

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Davis

Must not be taking: Anticoagulants

Disqualifiers: Heart failure, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for individuals with advanced pancreatic cancer. The goal is to determine the treatment's safety and effectiveness. It consists of two parts: a scan using a special marker ([68Ga]Ga DOTA-5G) to assess treatment suitability, followed by escalating doses of a radioactive drug ([177Lu]Lu DOTA-ABM-5G) to target the cancer. The trial seeks participants with pancreatic cancer that has spread or cannot be surgically removed and who have not succeeded with other treatments. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial requires that you stop any chemotherapy at least 2 weeks before the PET scan. If you are on chemical anticoagulants (blood thinners), you cannot participate in the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatment combination of [177Lu]Lu DOTA-ABM-5G and [68Ga]Ga DOTA-5G is under study for safety in humans. This marks the first human trial of this treatment. It uses two substances: one aids in visualizing the cancer, and the other targets and treats it, specifically focusing on pancreatic cancer.

At this early stage, the primary goal is to assess how well individuals tolerate the treatment. As this is the initial human trial, specific safety information remains limited. However, treatments like [177Lu]Lu DOTA-ABM-5G, which includes the radioactive element lutetium-177, have been used in other cancers and have shown promise for safety and effectiveness.

Since the study is in its early phases, researchers are still determining possible side effects and the optimal dosage. Early trials like this are crucial for understanding how the treatment functions in the body and ensuring its safety. Participants will be closely monitored for any adverse reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy or surgery, the DOTA-5G Pair offers a targeted approach using radiolabeled compounds. Researchers are excited because [177Lu]Lu DOTA-ABM-5G delivers radiation directly to cancer cells, minimizing damage to healthy tissue, a significant advantage over conventional treatments. Additionally, the use of [68Ga]Ga DOTA-5G PET/CT scans allows for precise patient selection, ensuring that only those likely to benefit receive the therapy. This targeted strategy not only has the potential to improve treatment effectiveness but also reduces side effects, making it a promising advancement in pancreatic cancer care.

What evidence suggests that the DOTA-5G theranostic pair could be effective for pancreatic cancer?

This trial will evaluate the use of [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G for treating pancreatic cancer. Research has shown that using these treatments together might be promising. Early studies provided positive results, indicating that [177Lu]Lu DOTA-ABM-5G can effectively target pancreatic cancer cells. In this trial, [68Ga]Ga DOTA-5G will locate the cancer, while [177Lu]Lu DOTA-ABM-5G will deliver radiation to kill the cancer cells. Initial findings suggest this approach may benefit patients with pancreatic cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Julie L Sutcliffe

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic pancreatic cancer who have finished chemotherapy at least two weeks prior and resolved any significant side effects. They must be able to lie still for scans, not have other active cancers needing treatment, no major surgery recently or coming up soon, and no severe infections or heart failure.

Inclusion Criteria

My scans show at least one cancer spot that's clearly visible.

Your blood counts need to be at a certain level: ANC (a type of white blood cell) should be at least 1000, platelet count should be at least 100,000, and hemoglobin should be at least 8.

Completion of entry into [68Ga]Ga DOTA-5G PET study and completion of scan

Exclusion Criteria

I haven't had major surgery in the last 28 days and don't plan any in the next 6 weeks.

Pregnant or lactating women

I am taking blood thinners other than aspirin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

PET/CT Imaging

Participants undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for [177Lu]Lu DOTA-ABM-5G therapy

1 day

1 visit (in-person)

Dose Escalation Therapy

Escalating doses of [177Lu]Lu DOTA-ABM-5G are administered in a 3+3 dose escalation design to identify the recommended phase 2 dose

30 days

Multiple visits (in-person)

Dose Expansion Cohort

10 additional patients receive the highest dose achieved in the dose escalation therapy study

30 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests a new theranostic pair [68Ga]Ga DOTA-5G (for imaging) and [177Lu]Lu DOTA-ABM-5G (for therapy) in patients with pancreatic cancer. It aims to assess the safety and effectiveness of these agents in detecting and treating the disease.

How Is the Trial Designed?

Group I: [177Lu]Lu DOTA-ABM-5G dose escalation therapy study Experimental Treatment 1 Intervention

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.

Group II: Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy study Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/64/supplement_1/p1300

First-in-human study of the theranostic pair [68Ga]Ga DOTA ... This is a Phase I, first-in-human study to evaluate the safety of the radiotheranostic peptide pair, [ 68 Ga]Ga DOTA-5G and [ 177 Lu]Lu DOTA-ABM-5G in patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36207137/

Preclinical Evaluation of 68 Ga- and 177 Lu-Labeled Integrin ... Favorable human dosimetry data suggest the potential of 177Lu-2 as a treatment for pancreatic ductal adenocarcinoma. Keywords: 177Lu; 68Ga; albumin-binding ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04665947

NCT04665947 | First-in-human Study of the Theranostic ... 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 ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-13843

Gallium Ga 68-DOTA-5G and Lutetium Lu 177-DOTA-ABM ... Gallium Ga 68-DOTA-5G and lutetium Lu 177-DOTA-ABM-5G may be an effective combination for diagnosing and treating patients with pancreatic cancer.

5. mycancergenome.org mycancergenome.org/content/drugs/[177Lu]Lu%20DOTA-ABM-5G/

[177lu]lu dota-abm-5g Pancreatic adenocarcinoma is the most common disease being investigated in [177lu]lu dota-abm-5g clinical trials [2]. References. 1. National Cancer Institute.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11002837/

Current clinical application of lutetium‑177 in solid tumors ... As a result, 177Lu can be used for both diagnosis and treatment for diseases such as prostatic and gastric cancer. Therefore, based on the available data, the ...