BI 765883 Alone or With Chemotherapy for Pancreatic Cancer

No longer recruiting at 22 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Gemcitabine, Paclitaxel

Disqualifiers: Neurologic, Psychiatric, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 350 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BI 765883, for individuals with advanced pancreatic cancer. The main goal is to determine the highest safe dose of BI 765883, both alone and with chemotherapy, and to assess its effectiveness against cancer. Participants will receive either BI 765883 alone or in combination with chemotherapy drugs gemcitabine and nab-paclitaxel (also known as Abraxane or albumin-bound paclitaxel). It is open to those with confirmed pancreatic cancer for whom previous treatments have not worked. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have had prior radiotherapy or systemic therapy within 14 days before starting the trial.

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

Research shows that BI 765883 is being tested in people for the first time to assess its safety. As this is an early-stage study, the main goal is to determine how well participants tolerate the treatment. There is no previous information on side effects or health issues for BI 765883 because it is new to humans.

For those receiving BI 765883 with chemotherapy, more information is available. Previous studies have shown that the combination of gemcitabine and nab-paclitaxel is usually well-tolerated. These drugs have been used together to treat pancreatic cancer before, and their safety is well-known. Common side effects can include tiredness, low blood counts, and hair loss, but these can differ from person to person.

The study is designed to carefully monitor any health problems or side effects participants might experience. This approach helps ensure the treatment's safety as researchers determine the right dose. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BI 765883 because it offers a novel approach to treating pancreatic cancer, a condition typically managed with chemotherapy combinations like gemcitabine and nab-paclitaxel. Unlike traditional treatments, BI 765883 works by targeting specific pathways involved in the growth and spread of cancer cells, potentially offering a more precise and effective means of combating the disease. This drug is being investigated both alone and in combination with standard chemotherapy, which may enhance its effectiveness and offer new hope for patients with this challenging cancer.

What evidence suggests that this trial's treatments could be effective for advanced pancreatic cancer?

Research shows that BI 765883 is currently being tested for advanced pancreatic cancer. This treatment is new in human trials, so limited information exists on its effectiveness. In this trial, some participants will receive BI 765883 alone, while others will receive it with the chemotherapy drugs gemcitabine and nab-paclitaxel. Past studies have shown these chemotherapy drugs significantly improve survival rates for patients with advanced pancreatic cancer by preventing cancer cell growth. The hope is that BI 765883, especially when combined with these chemotherapy drugs, may offer new hope for patients who haven't had success with other treatments. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults with advanced pancreatic cancer who have not had success with previous treatments or for whom no treatment exists. They must be able to provide informed consent, have a life expectancy of at least 3 months, and agree to use effective birth control. A confirmed diagnosis of Pancreatic ductal adenocarcinoma (PDAC) is required, along with an ECOG performance status ≤1.

Inclusion Criteria

I have signed and understand the consent form for this trial.

6. Life expectancy ≥3 months in the opinion of the investigator 7. Archived tumor tissue from a tissue core biopsy (e.g. paraffin-embedded formalin-fixed tissue blocks), OR fresh tumor tissue available for retrospective biomarker analysis; in both cases, a minimum of at least two core needle biopsies (18 gauge or greater) is required. Only non-significant risk procedures per the investigator's judgment will be used to obtain any biopsies specified in this study in cases where a fresh tumor biopsy is required.

I am using or willing to use effective birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 765883 alone or in combination with chemotherapy. The treatment continues as long as participants benefit and can tolerate it.

Up to 350 days

Regular study visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 765883
• gemcitabine
• nab-paclitaxel

Trial Overview The trial is testing the highest tolerable dose of BI 765883 alone or combined with chemotherapy in treating advanced pancreatic cancer. It's the first time BI 765883 is given to humans, aiming to check its effectiveness against this type of cancer.

How Is the Trial Designed?

Group I: BI 765883 escalation arm Experimental Treatment 1 Intervention

phase Ia

Group II: BI 765883 + gemcitabine + nab-paclitaxel expansion arm Experimental Treatment 3 Interventions

phase Ib

Group III: BI 765883 + gemcitabine + nab-paclitaxel escalation arm Experimental Treatment 3 Interventions

phase Ia

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

Pancreatic cancer, despite being a small percentage of overall cancer cases, is highly lethal, with only 10%-15% of patients having tumors that can be surgically removed, highlighting the need for effective treatment strategies.

Current treatment for locally advanced pancreatic cancer typically involves chemotherapy combined with radiation, but there is ongoing debate about the best chemotherapy agent to use, with research exploring biologically targeted therapies to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locally advanced pancreatic cancer: current therapeutic approach. Cardenes, HR., Chiorean, EG., Dewitt, J., et al.[2006]

Chemotherapy for advanced pancreatic cancer shows low overall activity but can provide a slight survival benefit and improve quality of life for some patients, as indicated by a systematic review of eight small randomized trials.

While gemcitabine is an approved treatment in some countries, there is no standard chemotherapy regimen established, and conclusive evidence for the use of adjuvant chemotherapy remains lacking due to the small number of patients in relevant trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy in the treatment of cancer of the pancreas. Glimelius, B.[2022]

Dovitinib, when combined with gemcitabine and capecitabine, was found to be safe at a recommended dose of 300 mg daily, with manageable side effects such as fatigue and neutropenia in a study involving 29 patients with advanced pancreatic and biliary tract cancers.

The combination treatment showed promising efficacy, with partial responses observed in 5 patients, indicating potential benefits for those suffering from advanced pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib Study of the FGFR/VEGFR Inhibitor Dovitinib With Gemcitabine and Capecitabine in Advanced Solid Tumor and Pancreatic Cancer Patients. Ma, WW., Xie, H., Fetterly, G., et al.[2022]

Neoadjuvant chemotherapy using S-1 and gemcitabine significantly improves survival rates for patients with resectable pancreatic cancer compared to immediate surgery, while maintaining similar perioperative outcomes.

Japanese guidelines now recommend neoadjuvant chemotherapy for resectable pancreatic cancer due to its ability to increase R0 resection rates, although identifying predictive markers for chemotherapy response is crucial to avoid missing surgical opportunities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present status and perspective of perioperative chemotherapy for patients with resectable pancreatic cancer in Japan. Yamada, Y.[2022]

Gemcitabine has changed the perception of pancreatic cancer treatment, showing good tolerability and low side effects, making it a viable option for combination therapies with drugs like cisplatin and 5-fluorouracil.

Combination regimens with gemcitabine and cisplatin have shown response rates between 11.4% and 58% and median survival times of 7.4 to 10 months, while gemcitabine with 5-FU has lower response rates and survival times, indicating the need for further optimization of treatment combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine-based combination treatment of pancreatic cancer. Heinemann, V.[2022]

In a phase 2 study involving 36 patients with advanced pancreatic cancer, the combination of cisplatin and gemcitabine showed promising activity, with 62.8% of patients achieving stable disease or better, and a median survival of 9.5 months.

While significant hematological toxicities were observed, they were mostly asymptomatic, and the treatment regimen demonstrated potential for improving survival, warranting further investigation in a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of weekly cisplatin and gemcitabine in patients with advanced pancreatic cancer: is this a strategy still worth pursuing? Clayton, AJ., Mansoor, AW., Jones, ET., et al.[2022]

Itacitinib, a selective JAK1 inhibitor, combined with nab-paclitaxel and gemcitabine, showed an acceptable safety profile and clinical activity in patients with advanced solid tumors, including pancreatic cancer, with a 24% overall response rate across various doses.

The study indicated that while itacitinib was tolerated at lower doses, treatment-related toxicities such as neutropenia and fatigue were common, leading to dose adjustments; however, the study was terminated early due to negative results from a related phase III trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. Beatty, GL., Shahda, S., Beck, T., et al.[2022]

In a phase II study involving 7 patients with advanced pancreatic cancer, the combination of panobinostat and bortezomib showed no treatment responses and was associated with significant early treatment-related toxicity, leading to the study's suspension.

The median progression-free survival for patients was only 2.1 months, with severe side effects such as thrombocytopenia occurring in 57% of patients and diarrhea in 29%, indicating that this treatment regimen is not effective or safe for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of panobinostat and bortezomib in patients with pancreatic cancer progressing on gemcitabine-based therapy. Wang, H., Cao, Q., Dudek, AZ.[2022]

In a randomized phase II trial involving 51 patients with borderline-resectable pancreatic cancer, neoadjuvant chemotherapy using either FOLFIRINOX or GEM/nab-PTX was found to be feasible and well tolerated, achieving an R0 resection rate of 67.4%.

The study reported a 3-year overall survival rate of 54.7% and a median survival time of 39.4 months, indicating that neoadjuvant chemotherapy can provide significant survival benefits despite a notable incidence of adverse events (45.1% experienced grade >3 adverse events).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a Phase II Study on the Use of Neoadjuvant Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT-01). Yamaguchi, J., Yokoyama, Y., Fujii, T., et al.[2023]

In a study of 190 patients with advanced pancreatic cancer, the three chemotherapy regimens (CapOx, CapGem, and mGemOx) showed similar efficacy, with median progression-free survival rates of 4.2 months, 5.7 months, and 3.9 months, respectively.

While all regimens had manageable toxicity profiles, the Gem-containing treatments (CapGem and mGemOx) were associated with higher rates of severe hematological toxicities, indicating that while effective, they may require closer monitoring for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer. Boeck, S., Hoehler, T., Seipelt, G., et al.[2022]

The ESPAC-4 trial demonstrated that combining gemcitabine with capecitabine significantly improves 5-year survival rates for patients undergoing surgery for pancreatic cancer compared to gemcitabine alone.

This finding is expected to change the standard treatment approach for pancreatic cancer patients who are eligible for surgery, highlighting the importance of combination therapy in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic Cancer Survival Increases with Chemo Combo. [2022]

In a study of 985 patients with pancreatic adenocarcinoma, completing all six cycles of adjuvant chemotherapy significantly improved overall survival rates, with a hazard ratio of 0.516, indicating a strong benefit for those who completed the full course.

The timing of chemotherapy initiation did not affect overall survival for the entire group, suggesting that delaying treatment for up to 12 weeks post-surgery is acceptable to allow for recovery, particularly for patients who may not complete the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal duration and timing of adjuvant chemotherapy after definitive surgery for ductal adenocarcinoma of the pancreas: ongoing lessons from the ESPAC-3 study. Valle, JW., Palmer, D., Jackson, R., et al.[2022]

In a phase II study involving 45 patients with unresectable or metastatic pancreatic cancer, the combination of irinotecan and gemcitabine showed promising efficacy, with a 20% overall response rate and a median survival of 5.7 months.

The treatment was well tolerated, with severe toxicities being rare, primarily consisting of low rates of grade 4 neutropenia and vomiting, indicating a favorable safety profile for this chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer. Rocha Lima, CM., Savarese, D., Bruckner, H., et al.[2022]

Despite gemcitabine being the first-line treatment for advanced pancreatic cancer for 15 years, median survival times have not significantly improved, with a pooled median survival of only 6.15 months from 21 trials involving 6348 patients.

Only one trial showed a significant improvement in survival when combining a novel agent with gemcitabine, highlighting the need for further research into new treatments to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled survival and response data from phase III randomized controlled trials for gemcitabine-based regimes in the treatment of advanced pancreatic cancer. Arshad, A., Al-Leswas, D., Al-Taan, O., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06528093

A Study to Find a Suitable Dose of BI 765883 and to Test ... The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with ...

2. withpower.com withpower.com/trial/phase-1-pancreatic-adenocarcinoma-ductal-adenocarcinoma-7-2024-bc002

BI 765883 Alone or With Chemotherapy for Pancreatic Cancer This study is open to adults with advanced pancreatic cancer for whom previous treatment was not successful or no treatment exists.The purpose of this study is ...

3. trial.medpath.com trial.medpath.com/news/3fef3740f4fd5333/a-first-in-human-open-label-phase-ia-ib-multicenter-multiregional-dose-escalation-study

BI 765883 - advanced pancreatic cancer - MedPath Pancreatic cancerSearch disease remains one of the most challenging malignancies to treat, with a five-year survival rate of approximately 10%. The development ...

4. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2024-0338.html

A first-in-human open label phase Ia/Ib, multicenter/ ... The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-09079

A Study to Find a Suitable Dose of BI 765883 and to Test ... The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06528093/a-study-to-find-a-suitable-dose-of-bi-765883-and-to-test-whether-it-helps-people-with-advanced-pancreatic-cancer-when-taken-alone-or-together-with-chemotherapy

A Study to Find a Suitable Dose of BI 765883 and to Test ... The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with ...