A Phase Ib Dose Escalation/Dose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Dose Escalation Part Objectives:

To establish the preliminary recommended Phase II dose (RP2D) for PTM-101 when used as an adjunct to neoadjuvant therapy in subjects with treatment naïve, borderline resectable or locally advanced PDAC
To characterize the safety and pharmacokinetic profile of a single administration of PTM-101, at two dose levels, when used as an adjunct to neoadjuvant therapy in subjects with treatment naïve, borderline resectable or locally advanced PDAC

Dose Expansion Part Objective:

To assess early efficacy of PTM-101 when used at the preliminary RP2D as an adjunct to neoadjuvant therapy in subjects with treatment naïve, borderline resectable or locally advanced PDAC

Eligibility

Inclusion Criteria:

Imaging consistent with primary PDAC (if PDAC is to be confirmed at study-mandated laparoscopy) or imaging consistent with primary PDAC with prior biopsy/cytology
No radiographic or physical exam evidence of metastatic disease
No prior chemo-, radio-, or surgical therapy for PDAC
Acceptable laboratory values
CA 19-9 <500 U/mL at baseline after biliary decompression
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Ability to provide informed consent
No signs or symptoms of pancreatitis
No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation
Subjects with childbearing potential must agree to use adequate contraception throughout study participation

Exclusion Criteria:

Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancers, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to screening)
Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or chemotherapies in protocol (e.g., FOLFIRINOX, gemcitabine, nab-paclitaxel)
Known human immunodeficiency virus (HIV) or active viral hepatitis
Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor
Inability to comply with activities and therapeutic interventions as outlined in the schedule of events
Currently enrolled in another investigational drug or device trial
Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices