Trial · NCT06904378
ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
NCT06904378, Phase 1, Phase 2, Recruiting, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma. Trials, record NCT06904378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06904378
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma
- NCT number
- NCT06904378
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 61 participants, estimated
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Interventions
- ONT01, Gemcitabine, Nab paclitaxel
- First posted
- 2025-04-01
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose (RP2D) (Phase I only) | After completion of cycle 1 (each cycle is 28 day) for all Phase I participants (estimated to be 12 months) | The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. In the absence of excess toxicity, the maximum tolerated dose will become the recommended phase 2 dose (RP2D). |
| Primary | Number of participants with dose-limiting toxicities (DLTs) (Phase I only) | After completion of cycle 1 (each cycle is 28 days) | DLTs are defined in the protocol. |
| Primary | Progression-free rate at 6 months (RP2D participants in Phase I and Phase II participants only) | At 6 months from start of treatment | |
| Secondary | Frequency of adverse events (RP2D participants in Phase I and Phase II participants in experimental arm only) | From start of treatment through 30 days after last dose of treatment (estimated to be 7 months) | \- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. |
| Secondary | Objective response rate (ORR) (RP2D participants in Phase I and Phase II participants in experimental arm only) | Through completion of treatment (estimated to be 6 months) | * ORR is defined as the proportion of patients with disease control (Complete response + Partial response). * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Progression-free survival (PFS) (RP2D participants in Phase I and Phase II participants in experimental arm only) | Through completion of follow-up (estimated to be 18 months) | * PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
| Secondary | Overall survival (OS) (RP2D participants in Phase I and Phase II participants in experimental arm only) | Through completion of follow-up (estimated to be 18 months) | OS is defined as the duration of time from start of treatment to time of death from any cause. The alive patients are censored at last follow-up date. |
| Secondary | Disease control rate (DCR) (RP2D participants in Phase I and Phase II participants in experimental arm only) | Through completion of follow-up (estimated to be 18 months) | * DCR is defined as the proportion of patients with disease control (Complete response + Partial response + Stable Disease) per RECIST 1.1. * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50CA272213 | Washington University SPORE in Pancreatic Cancer | DENARDO, DAVID G; HAWKINS, WILLIAM G; LIM, KIAN H | WASHINGTON UNIVERSITY | NATIONAL CANCER INSTITUTE | 2023 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06904378
GET https://conductscience.org/api/trials/v1/NCT06904378/registered