Clinical trial · Interventional
Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer
An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial has been terminated earlier following the company decision to discontinue the clinical development of Evofosfamide
Summary
Brief summary (as posted)
This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| TH-302 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TH-302 plus Nab-paclitaxel plus Gemcitabine
- interventionNames
- Drug: TH-302
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
- timeFrame
- Up to Day 28 of Cycle 1
Secondary outcomes (6)
- measure
- Progression Free Survival (PFS) Time
- timeFrame
- Time from enrollment to progressive disease (PD) or occurrence of death due to any cause within 120 days of either first administration of study drug or the last tumor assessment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects greater than or equal to (\>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than: * Radiosensitizing doses of 5-fluorouracil; * Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine; * Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection; * Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy * Subjects may have measurable or non-measurable disease according to RECIST 1.1. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Acceptable hematological status, liver and renal function as defined in the protocol * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Significant cardiac or peripheral vascular arterial disease * Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months) * Severe chronic obstructive or other pulmonary disease with hypoxemia * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Subjects receiving concomitant treatment with radiotherapy or other investigational drugs * Other protocol defined exclusion criteria could apply
References
Publications (1)
- DERIVEDSun JD, Liu Q, Ahluwalia D, Li W, Meng F, Wang Y, Bhupathi D, Ruprell AS, Hart CP. Efficacy and safety of the hypoxia-activated prodrug TH-302 in combination with gemcitabine and nab-paclitaxel in human tumor xenograft models of pancreatic cancer. Cancer Biol Ther. 2015;16(3):438-49. doi: 10.1080/15384047.2014.1003005. PMID 25679067