Trial · NCT04492033
A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
NCT04492033, Phase 1, Phase 2, Terminated, Handok Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients. Trials, record NCT04492033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04492033
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
- NCT number
- NCT04492033
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Handok Inc.
- Conditions
- P1b: Advanced Solid Tumors, P2: Biliary Tract Cancer
- Interventions
- CTX-009 (ABL001), Paclitaxel, Irinotecan
- First posted
- 2020-07-30
- Last updated
- 2025-01-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT) | From Day 1 until disease progression or Day 28, whichever came first | Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects |
| Primary | P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC | Up to approximately 24 months | The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review |
| Secondary | Adverse Events (AEs) | Up to approximately 24 months | Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Secondary | Pharmacokinetics (PK) of CTX-009 (ABL001) | Up to approximately 24 months | Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001) |
| Secondary | Objective response rate (ORR) | Up to approximately 24 months | Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review |
| Secondary | Disease control rate (DCR) | Up to approximately 24 months | Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) |
| Secondary | Time to treatment failure (TTF) | Up to approximately 24 months | Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first |
| Secondary | Duration of response (DOR) | Up to approximately 24 months | Time interval from first occurrence of a documented objective response to the time of disease progression |
| Secondary | Progression-free survival (PFS) | Up to approximately 24 months | The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death |
| Secondary | P2: Survival rate | 6 months and 12 months | The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Grants0
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.
None in this release.
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/NCT04492033
GET https://conductscience.org/api/trials/v1/NCT04492033/registered