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A first-in-human clinical study of PBP1510 in patients with pancreatic cancer.
EU CTIS ID: 2024-514379-16-00
What this study is testing
Part 1 (Phase 1): To evaluate the safety and tolerability of PBP1510 administered as monotherapy, and in combination with gemcitabine, following intravenous (IV) administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. Part 2 (Phase 2a): To establish the safety and assess the efficacy of PBP1510 administered at the RP2D in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults ≥ 18 years of age (or the legal age of majority in the country of recruitment) at the time consent is obtained.
- Have a life expectancy of ≥ 3 months.
- At least one measurable lesion as per RECIST v1.1.
- Adequate baseline organ function defined as: a) ANC: ≥ 1.5 × 10^9 /L; b) Haemoglobin: ≥ 9 g/dL; c) Platelets: ≥ 100 × 10^9 /L; d) Total bilirubin: ≤ 2 × ULN (≤ 3 x ULN for patients with biliary stenting and patients with Gilbert’s syndrome); e) AST and ALT: < 3 x ULN (≤ 5 x ULN for patients with hepatic metastases); f) Creatine clearance (as determined by the Cockcroft Gault formula): ≥ 50 mL/min; g) LVEF: ≥ 50% by ECHO or MUGA; h) QTc: ≤ 470 ms
- Female patients of nonchildbearing potential, must meet at least 1 of the following criteria: have undergone a documented hysterectomy, and/or bilateral oophorectomy; have medically confirmed ovarian failure or achieved postmenopausal status. A postmenopausal state is defined as cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a follicle-stimulating hormone (FSH) level confirming the postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. Female patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to and negative urine pregnancy test just prior to the first dose of PBP1510 and agree to use effective contraception, in accordance with the recommendations of the Clinical Trials Facilitation and Coordination Group (CTFG) from study entry and until for at least 6 months after the last dose of PBP1510.
- For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) from study entry and until for at least 6 months after the last dose of PBP1510. Investigator or his/her representative should discuss acceptable pregnancy prevention method(s) with the patients. Highly effective methods of birth control include those that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, levonorgestrel-releasing intrauterine system, intrauterine devices (IUD), and true sexual abstinence.
You likely can't join if
- Patients who have known brain metastases will be excluded from the study. However, a patient may be included in the study, if has been previously treated for brain metastasis, the disease is well controlled for at least 3 months, and the patient is off steroids.
- Patients currently receiving radiation therapy or those having received radiation within 2 weeks prior to first dose of PBP1510. Patients must have recovered from the toxic effects of their treatment prior to first dose of study drug.
- Patients having received investigational anti-cancer drug within 28 days (or 5 half-lives, whichever is shorter) preceding the first dose of PBP1510 or chemotherapy within the last 2 weeks prior to the first dose of PBP1510. Patients must have recovered from the toxic effects of their treatment prior to first dose of study drug.
- Patients with known allergy or hypersensitivity to components of the PBP1510 formulation including the excipients and history of hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Patients who are pregnant, or breast feeding.
- Patients who are unwilling or unable to comply with study procedures.
See the full eligibility criteria
Who can join
- Adults ≥ 18 years of age (or the legal age of majority in the country of recruitment) at the time consent is obtained.
- Have a life expectancy of ≥ 3 months.
- At least one measurable lesion as per RECIST v1.1.
- Adequate baseline organ function defined as: a) ANC: ≥ 1.5 × 10^9 /L; b) Haemoglobin: ≥ 9 g/dL; c) Platelets: ≥ 100 × 10^9 /L; d) Total bilirubin: ≤ 2 × ULN (≤ 3 x ULN for patients with biliary stenting and patients with Gilbert’s syndrome); e) AST and ALT: < 3 x ULN (≤ 5 x ULN for patients with hepatic metastases); f) Creatine clearance (as determined by the Cockcroft Gault formula): ≥ 50 mL/min; g) LVEF: ≥ 50% by ECHO or MUGA; h) QTc: ≤ 470 ms
- Female patients of nonchildbearing potential, must meet at least 1 of the following criteria: have undergone a documented hysterectomy, and/or bilateral oophorectomy; have medically confirmed ovarian failure or achieved postmenopausal status. A postmenopausal state is defined as cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a follicle-stimulating hormone (FSH) level confirming the postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. Female patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to and negative urine pregnancy test just prior to the first dose of PBP1510 and agree to use effective contraception, in accordance with the recommendations of the Clinical Trials Facilitation and Coordination Group (CTFG) from study entry and until for at least 6 months after the last dose of PBP1510.
- For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) from study entry and until for at least 6 months after the last dose of PBP1510. Investigator or his/her representative should discuss acceptable pregnancy prevention method(s) with the patients. Highly effective methods of birth control include those that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, levonorgestrel-releasing intrauterine system, intrauterine devices (IUD), and true sexual abstinence.
- Patients must be willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
- Patients enrolling into Part 1 (Phase 1) of the study must also meet the following inclusion criteria: Monotherapy and combination cohorts: advanced/metastatic pancreatic cancer patients whose tumours have progressed after at least one prior line of standard chemotherapy.
- Patients enrolling into Part 2 (Phase 2a) of the study must also meet the following inclusion criteria: Advanced/metastatic pancreatic cancer patients whose tumours have progressed after one prior line of standard chemotherapy.
- Patient should understand, voluntarily sign, and date the written consent form prior to any protocol-specific procedures.
- Performance Status score less than or equal to 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Have histological or cytological evidence of a diagnosis of pancreatic adenocarcinoma that is advanced and/or metastatic.
What rules you out
- Patients who have known brain metastases will be excluded from the study. However, a patient may be included in the study, if has been previously treated for brain metastasis, the disease is well controlled for at least 3 months, and the patient is off steroids.
- Patients currently receiving radiation therapy or those having received radiation within 2 weeks prior to first dose of PBP1510. Patients must have recovered from the toxic effects of their treatment prior to first dose of study drug.
- Patients having received investigational anti-cancer drug within 28 days (or 5 half-lives, whichever is shorter) preceding the first dose of PBP1510 or chemotherapy within the last 2 weeks prior to the first dose of PBP1510. Patients must have recovered from the toxic effects of their treatment prior to first dose of study drug.
- Patients with known allergy or hypersensitivity to components of the PBP1510 formulation including the excipients and history of hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Patients who are pregnant, or breast feeding.
- Patients who are unwilling or unable to comply with study procedures.
- Patients who are not eligible to participate in this study, as judged by Investigators.
- A history of allergic reactions attributed to gemcitabine or compounds of similar chemical composition to gemcitabine and/or previous treatment discontinuation due to gemcitabine toxicity.
- Patients who have undergone a major surgery within 4 weeks prior to the start of PBP1510 administration.
- Patients who have active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, e.g., an active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii (P. carinii), or other microorganisms that is under treatment with myelotoxic drugs.
- Patient has a known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
- Patient currently has active hepatitis B, hepatitis C, or syphilis.
- Patient has impaired cardiac function and uncontrolled cardiac diseases/hypertension that are deemed clinically significant by the Investigator and which could compromise the patient’s safety or the study data integrity.
- Patient has serious psychiatric disorders, which could compromise the patient’s safety or the study data integrity.
- Any other malignancy from which the patient has been disease-free for less than 2 years, except for adequately treated and cured basal or squamous cell skin cancer.
- Patients who are enrolled in any other therapeutic clinical trial, unless they have confirmed disease progression in the trial and area in follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.