A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer

Who is this study for? Patients with Pancreatic Cancer
What treatments are being studied? PBP1510
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ Patients enrolling into Part 1 (Phase 1), or Part 2 (Phase 2a) must meet all of the following 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.

• At least one measurable lesion as per RECIST v1.1

• Adequate baseline organ function defined as:

• ANC ≥ 1.5 × 10\^9 /L; Haemoglobin ≥ 9 g/dL; Platelets ≥ 100 × 10\^9 /L; Total bilirubin ≤ 2 × ULN (≤ 3 x ULN for patients with biliary stenting and patients with Gilbert's syndrome); AST and ALT \< 3 x ULN (≤ 5 x ULN for patients with hepatic metastases); Serum creatinine OR creatinine clearance (as determined by the Cockcroft Gault formula) OR eGFR based on MDRD ≤ 1.5 x ULN OR ≥ 50 mL/min OR ≥ 50 mL/min/1.73 m\^2; LVEF ≥ 50% by ECHO or MUGA; 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, intra-uterine devices (IUDs), 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.

Locations
United States
New York
Northwell Health / R.J. Zuckerberg Cancer Center
RECRUITING
New Hyde Park
Other Locations
Australia
Monash Health
RECRUITING
Melbourne
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Contact Information
Primary
Mei Li Lim
meili.lim@prestigebio.com
+65-6924-6535
Backup
Fang Ting Pan
fangting.pan@prestigebio.com
+65-6924-6535
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 80
Treatments
Experimental: Cohort 1M
1 mg/kg of PBP1510 as monotherapy will be administered
Experimental: Cohort 1C
1 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
Experimental: Cohort 2M
3 mg/kg of PBP1510 as monotherapy will be administered
Experimental: Cohort 2C
3 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
Experimental: Cohort 3M
6 mg/kg of PBP1510 as monotherapy will be administered
Experimental: Cohort 3C
6 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
Experimental: Cohort 4M
10 mg/kg of PBP1510 as monotherapy will be administered
Experimental: Cohort 4C
10 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
Experimental: Cohort 5M
15 mg/kg of PBP1510 as monotherapy will be administered
Experimental: Cohort 5C
15 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
Related Therapeutic Areas
Sponsors
Leads: Prestige Biopharma Limited

This content was sourced from clinicaltrials.gov

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