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Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC

NCT06592664 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-06-06

No results posted yet for this study

Summary

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.

The main questions it aims to answer are:

* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment

Participants will:

* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

Conditions

Interventions

DRUG

certepetide

certepetide given as an IV push over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given

DRUG

nab-paclitaxel

nab-paclitaxel 125 mg/m\^2 IV administered on Day 1, 8, and 15 every 28 days

DRUG

gemcitabine

gemcitabine 1000 mg/m\^2 IV administered on Day 1, 8, and 15 every 28 days

DRUG

placebo matching certepetide

placebo given as two IV pushes over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given

DRUG

certepetide

certepetide given as two IV pushes over 1 minute when standard treatment(s) are given

DRUG

placebo matching certepetide

placebo given as an IV infusion over 4 hours when standard treatment(s) are given

DRUG

placebo matching certepetide

certepetide given as a slow IV push over 1 minute when standard treatment(s) are given

Sponsors & Collaborators

  • Lisata Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Kristen K. Buck, MD · Lisata Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2030-01-31
Primary Completion
2035-01-31
Completion
2040-01-31
FDA Drug
Yes

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592664 on ClinicalTrials.gov