A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma

Dong-A ST

Status and phase: Enrolling; Phase 1

Conditions: Pancreatic Ductal Adenocarcinoma (mPDAC); GastroEsophageal Cancer; Gastric (Stomach) Cancer

Treatments: Drug: DA-3501

Study type: Interventional

Funder types: Industry

Identifiers

NCT07481357

DA3501_AMST_I/IIa

Details and patient eligibility

About

The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC/GEJ and advanced CLDN18.2+ PDAC.

Participants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.

Enrollment: 51 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged ≥ 19 years
2. Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC
3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
4. Life expectancy ≥12 weeks as judged by the Investigator

Exclusion criteria

1. Cardiac abnormalities
2. Gastrointestinal abnormalities
3. Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV).
4. Active systemic infection requiring IV antibiotics therapy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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51 participants in 11 patient groups

Dose Level 1

Experimental group

Description:

Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks.

Treatment:

Drug: DA-3501

Dose Level 2

Experimental group

Treatment:

Drug: DA-3501

Dose Level 3

Experimental group

Treatment:

Drug: DA-3501

Dose Level 4

Experimental group

Treatment:

Drug: DA-3501

Dose Level 5

Experimental group

Treatment:

Drug: DA-3501

Dose Level 6

Experimental group

Treatment:

Drug: DA-3501

Dose Level 7

Experimental group

Treatment:

Drug: DA-3501

Dose Level 8

Experimental group

Treatment:

Drug: DA-3501

Dose Level 9

Experimental group

Treatment:

Drug: DA-3501

Dose Level 10

Experimental group

Treatment:

Drug: DA-3501

Dose Level 11

Experimental group

Treatment:

Drug: DA-3501