PBP1510 + Gemcitabine for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Prestige Biopharma Limited

Must be taking: Gemcitabine

Disqualifiers: Brain metastases, HIV, Hepatitis B, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called PBP1510, alone or with gemcitabine, in patients with advanced pancreatic cancer that hasn't responded to previous treatments. The goal is to see if PBP1510 can help stop or slow down the growth of their tumors. Gemcitabine has been a standard treatment for advanced pancreatic cancer, often used alone or in combination with other drugs to improve efficacy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.

What data supports the effectiveness of the drug combination PBP1510 + Gemcitabine for pancreatic cancer?

Research shows that gemcitabine, when combined with other drugs like nab-paclitaxel, can improve survival in advanced pancreatic cancer compared to using gemcitabine alone. This suggests that combining gemcitabine with other treatments might be more effective than using it by itself. ^{1 2 3 4 5}

What safety data exists for Gemcitabine in combination with other treatments for pancreatic cancer?

Gemcitabine, when combined with other treatments like nab-paclitaxel, has shown an acceptable safety profile in patients with advanced solid tumors, including pancreatic cancer. ^{1 5 6 7 8}

What makes the drug PBP1510 + Gemcitabine unique for treating pancreatic cancer?

PBP1510 combined with Gemcitabine is unique because it introduces a novel component, Ulenistamab, which may offer a new mechanism of action compared to existing treatments that primarily focus on targeting the epidermal growth factor receptor (EGFR) or other pathways. This combination could potentially provide a different approach to managing pancreatic cancer, which is known for being difficult to treat. ^{5 7 9 10 11}

Eligibility Criteria

Adults over 18 with advanced/metastatic pancreatic cancer, who have had at least one line of standard chemotherapy, can join this trial. They must be in relatively good health (ECOG score ≤1), expect to live more than 3 months, and have no other major illnesses or recent surgeries that could affect the study. Women must not be pregnant and agree to use effective contraception.

Inclusion Criteria

You have at least one specific spot that can be measured according to a certain set of rules.

Patients enrolling into Part 1 (Phase 1) of the study must also meet the following inclusion criteria:

Criterion: Your blood counts, liver function, kidney function, and heart function need to be within certain normal ranges for you to participate in the trial.

Exclusion Criteria

Patients who are not eligible to participate in this study, as judged by Investigators.

I have heart problems that are not well-controlled.

You are allergic to any ingredients in the PBP1510 drug, or have had a bad reaction to similar medications made from Chinese hamster ovary cells or other genetically engineered antibodies.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation (Phase 1)

PBP1510 is administered as monotherapy or in combination with gemcitabine to determine the recommended Phase 2a dose (RP2D).

4 cycles of 28 days each

Multiple visits per cycle (C1D1, C1D8, C1D15, etc.)

Dose-Expansion (Phase 2a)

Patients receive the RP2D of PBP1510 in combination with gemcitabine to assess efficacy and safety.

4 cycles of 28 days each

Multiple visits per cycle (C1D1, C1D8, C1D15, etc.)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

90 days after last dose

Safety Follow Up visit

Treatment Details

Interventions

• Gemcitabine (Anti-metabolites)
• PBP1510 (Monoclonal Antibodies)

Trial Overview The trial is testing PBP1510 alone and combined with gemcitabine in patients with pancreatic cancer. It's a two-part study: first part tests different doses of PBP1510 alone and then with gemcitabine; second part expands the dose found to be safe in combination with gemcitabine.

Participant Groups

Group I: Cohort 5M Experimental Treatment 1 Intervention

15 mg/kg of PBP1510 as monotherapy will be administered

Group II: Cohort 5C Experimental Treatment 2 Interventions

15 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Group III: Cohort 4M Experimental Treatment 1 Intervention

10 mg/kg of PBP1510 as monotherapy will be administered

Group IV: Cohort 4C Experimental Treatment 2 Interventions

10 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Group V: Cohort 3M Experimental Treatment 1 Intervention

6 mg/kg of PBP1510 as monotherapy will be administered

Group VI: Cohort 3C Experimental Treatment 2 Interventions

6 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Group VII: Cohort 2M Experimental Treatment 1 Intervention

3 mg/kg of PBP1510 as monotherapy will be administered

Group VIII: Cohort 2C Experimental Treatment 2 Interventions

3 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Group IX: Cohort 1M Experimental Treatment 1 Intervention

1 mg/kg of PBP1510 as monotherapy will be administered

Group X: Cohort 1C Experimental Treatment 2 Interventions

1 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

🇺🇸 Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

🇨🇦 Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

🇯🇵 Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwell Health / R.J. Zuckerberg Cancer Center New Hyde Park, NY

Who Is Running the Clinical Trial?

Prestige Biopharma Limited Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate. [2022] This phase III, randomized, open-label, multicenter study compared the overall survival associated with irinotecan plus gemcitabine (IRINOGEM) versus gemcitabine monotherapy (GEM) in patients with chemotherapy-naive, locally advanced or metastatic pancreatic cancer.

2. United States pubmed.ncbi.nlm.nih.gov

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer. [2023] Gemcitabine-nab-paclitaxel (GEMNAB) and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) both improve survival of patients with advanced pancreatic cancer when compared with single-agent gemcitabine in clinical trials.

3. England pubmed.ncbi.nlm.nih.gov

The combination of a chemotherapy doublet (gemcitabine and capecitabine) with a biological doublet (bevacizumab and erlotinib) in patients with advanced pancreatic adenocarcinoma. The results of a phase I/II study. [2022] Preclinical data support the combined inhibition of vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR) pathways in the treatment of pancreatic cancer. Following a dose finding phase I study the efficacy and toxicity of a four-drug regimen utilising the cytotoxic doublet of gemcitabine and capecitabine (GemCap), with the biological doublet of erlotinib and bevacizumab were further assessed in patients with advanced pancreatic cancer.

4. England pubmed.ncbi.nlm.nih.gov

P21-activated kinase 1 (Pak1) signaling influences therapeutic outcome in pancreatic cancer. [2022] Therapeutic resistance to gemcitabine in pancreatic ductal adenocarcinoma (PDAC) is attributed to various cellular mechanisms and signaling molecules that influence as a single factor or in combination.

5. England pubmed.ncbi.nlm.nih.gov

A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. [2022] Label="LESSONS LEARNED">Itacitinib in combination with nab-paclitaxel plus gemcitabine demonstrated an acceptable safety profile with clinical activity in patients with advanced solid tumors including pancreatic cancer.The results support future studies of itacitinib as a component of combination regimens with other immunologic and targeted small molecule anticancer agents.

6. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. [2022] This phase III trial compared the efficacy and safety of gemcitabine (Gem) plus capecitabine (GemCap) versus single-agent Gem in advanced/metastatic pancreatic cancer.

7. United States pubmed.ncbi.nlm.nih.gov

Dose finding and early efficacy study of gemcitabine plus capecitabine in combination with bevacizumab plus erlotinib in advanced pancreatic cancer. [2022] This study evaluated safety and efficacy of chemotherapy (gemcitabine plus capecitabine) plus bevacizumab/erlotinib in advanced pancreatic cancer because dual epidermal growth factor receptor/vascular endothelial growth factor blockade has a rational biologic basis in this malignancy.

8. England pubmed.ncbi.nlm.nih.gov

Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. [2022] Cediranib and olaparib combination did not result in clinically meaningful activity in patients with metastatic pancreatic ductal adenocarcinoma without known BRCA mutation.

9. England pubmed.ncbi.nlm.nih.gov

Her signaling in pancreatic cancer. [2022] Pancreatic cancer remains a treatment-refractory cancer. Standard therapy for metastatic cancer is gemcitabine chemotherapy, with a median survival of 5-6 months. The epidermal growth factor receptor (EGFR) is commonly expressed in pancreatic cancer and has been evaluated as a therapeutic target. A Phase III trial of gemcitabine with or without the EGFR inhibitor, erlotinib, demonstrated a modest but significant prolongation of survival with the addition of erlotinib. A Phase II trial of gemcitabine with the anti-EGFR antibody cetuximab resulted in a 1-year survival of 32%. A Phase III trial of gemcitabine with or without cetuximab and a randomized Phase II trial of the Murren regimen with or without cetuximab are completed; results for both are anticipated in 2007. A Phase I trial of gemcitabine with the EGFR/Her-2 inhibitor, lapatinib, is completed. Improved patient selection and rational combination of targeted therapies will be necessary to optimize the management of patients with this tragic disease.

10. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium. [2022] Sorafenib, an inhibitor of B-raf, VEGFR2, and PDGFR-β, has activity against pancreatic cancer in preclinical models. In a phase I trial of gemcitabine plus sorafenib, 57% of pancreatic cancer patients achieved stable disease.

11. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine plus nab-paclitaxel versus FOLFIRINOX for unresected pancreatic cancer: Comparative effectiveness and evaluation of tumor growth in Veterans. [2023] Advanced, unresectable pancreatic cancer is often treated with either gemcitabine plus nab-paclitaxel (Gem/NabP) or FOLFIRINOX, although these regimens have never been compared in a head-to-head trial. In this study, we compared these two regimens using Veterans Administration (VA) data and evaluated the use of a novel tumor growth formula to predict outcomes.