First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
NCT04665947 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-29
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
Interventions
- DRUG
-
[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.
Sponsors & Collaborators
-
University of California, Davis
lead OTHER
Principal Investigators
-
Julie L Sutcliffe · University of California, Davis
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-18
- Primary Completion
- 2027-07-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
NCT04233866 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor AZD1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT02194829 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
NCT00003810 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas
NCT00038701 ·Status: TERMINATED ·Phase: PHASE2
-
Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations
NCT06998940 ·Status: RECRUITING ·Phase: PHASE3
-
Phase 1 Study of Preoperative Gemcitabine Plus CP-870, 893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma
NCT01456585 ·Status: COMPLETED ·Phase: PHASE1
-
CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer
NCT05685602 ·Status: SUSPENDED ·Phase: PHASE1
-
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
NCT01505530 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery
NCT02336087 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
NCT00320749 ·Status: COMPLETED ·Phase: PHASE1
-
Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer
NCT04447092 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
NCT05047991 ·Status: UNKNOWN ·Phase: PHASE2
-
First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI
NCT03693677 ·Status: COMPLETED ·Phase: PHASE2
-
Dinaciclib and Akt Inhibitor MK2206 in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery
NCT01783171 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
NCT02399137 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer
NCT05669482 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer
NCT02283372 ·Status: COMPLETED ·Phase: PHASE1
-
Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
NCT03412799 ·Status: COMPLETED ·Phase: PHASE1
-
In Vitro Organoid Drug Sensitivity-Guided Treatment for Metastatic Pancreatic and Gastric Cancer
NCT05842187 ·Status: UNKNOWN ·Phase: NA
-
Irinotecan Liposome,Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer
NCT06513455 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients
NCT02707159 ·Status: COMPLETED ·Phase: PHASE2
-
Adebrelimab Infusion Plus Standard Care for Pancreatic Cancer With Pleural or Peritoneal Effusions
NCT07230301 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer
NCT01232829 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer
NCT02707315 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
NCT07283705 ·Status: RECRUITING ·Phase: PHASE2