A Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

BicycleTx

Status and phase

Enrolling

Phase 2

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Treatments

Drug: BT5528

Study type

Interventional

Funder types

Industry

Identifiers

NCT07450859

BT5528-201

Details and patient eligibility

About

This is a Phase 2 study for BT5528 in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one previous treatment.

The drug, BT5528, is designed to find a specific protein called EphA2.

The main aims of the study are to see how well the drug works against the tumor (efficacy), what side effects it may have (safety), and how the body processes it (pharmacokinetics). All participants in this study will receive BT5528, and both they and their doctors will know what is being administered (single-arm, open-label). The trial will take place at several different medical centers.

Full description

This is a Phase 2, open-label, multicenter, single-arm study to evaluate the efficacy, safety, and pharmacokinetics (PK) of BT5528 in adult participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after one prior line of systemic therapy. BT5528 is a novel Bicycle® drug conjugate (BDC®) that targets EphA2, a protein often found on cancer cells, and delivers a potent anti-cancer agent (MMAE).

Enrollment

39 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

At least 18 years of age at the time of signature of the informed consent form
Measurable disease as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 12 weeks
Histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC)
Participants must have failed only 1 prior line of therapy with evidence of radiographic progression. Neoadjuvant or adjuvant systemic therapy may count as the first line if the participant progressed less than 6 months from the end of systemic therapy. Prior treatment with KRAS inhibitors is permitted
Participants must have sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers
Adequate organ function (hematologic, renal, and hepatic)
Negative pregnancy test for participants of childbearing potential (POCBP)
Must be willing and able to comply with the protocol and study procedures

Exclusion Criteria

Chemotherapy or radiotherapy within 14 days prior to the first dose of study treatment
Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of BT5528 study treatment
Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer or prior treatment with any MMAE-containing agent
Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy
Prior toxicities must have resolved to Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Untreated central nervous system (CNS) metastases

Note: Additional protocol defined Inclusion/Exclusion criteria apply