First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With… (NCT05141149) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer
United States, Australia, Singapore80 participantsStarted 2023-06-05
Plain-language summary
The first in human clinical study is planned as an open-label, dose-escalation, and dose-expansion, multicentre, two-part, Phase 1/2a study of PBP1510 administered to patients with advanced/metastatic pancreatic cancer. The study will be conducted in two parts, Part 1 as a PBP1510 single agent dose-escalation, and PBP1510 dose-escalation in combination with gemcitabine, and Part 2 as PBP1510 dose-expansion at the RP2D in combination with gemcitabine.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults ≥ 18 years of age (or the legal age of majority in the country of recruitment) at the time consent is obtained.
. 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 cancer that is advanced and/or metastatic.
. Have a life expectancy of ≥ 3 months.
. No other malignancy present that would interfere with the current intervention.
. Prior radiation therapy for treatment of cancer is allowed to \< 25% of the bone marrow, and patients must have recovered from the acute toxic effects of their treatment prior to study enrolment. Prior radiotherapy must be completed at least 4 weeks before the first dose of study treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PART 1 (PHASE 1): To evaluate safety and tolerability of PBP1510
Timeframe: Baseline to Safety Follow Up visit (90 days after last dose of PBP1510)
2
PART 1 (PHASE 1): Dose limiting toxicity (DLT) evaluation
Timeframe: During first treatment cycle (each cycle is 28 days)
3
PART 2 (PHASE 2a): To establish safety of PBP1510 in combination with gemcitabine
Timeframe: Baseline to Safety Follow Up visit (90 days after last dose of PBP1510)
4
PART 2 (PHASE 2a): To assess the efficacy of PBP1510 in combination with gemcitabine
Timeframe: Baseline to End of Treatment visit (28 days after last dose of PBP1510)
5
PART 1 (PHASE 1): Determine the recommended Phase 2a dose (R2PD) of PBP1510
Timeframe: After last patient enrolled in last dosing cohort completes 4 cycles of treatment. Each cycle is 28 days.
. At least one measurable lesion as per RECIST v1.1
Exclusion criteria
. 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 who have undergone a major surgery within 4 weeks prior to the start of PBP1510 administration, other than endoscopic/radiation procedures, bypass surgery (i.e., gastrojejunostomy), laparoscopy, port placement or a diagnostic surgery (i.e., surgery done to obtain a diagnostic biopsy, without removal of an organ), as long as the patient has recovered from these minor surgical procedures.
. 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 has known history of or currently active hepatitis B (e.g., hepatitis B antigen \[HBsAg\] reactive), hepatitis C (e.g., HCV RNA \[qualitative\] is detected) or syphilis \[Venereal Disease Research Laboratory (VDRL) to detect antibodies in blood\]).
. 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 5 years, except for adequately treated and cured basal or squamous cell skin cancer.