NCT05249101

A Phase 1b/2, Dose-escalation, Randomized, Multicenter Study of Maintenance Ivaltinostat Plus Capecitabine or Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on FOLFIRINOX

Active, enrolled Phase 1/Phase 2 Last updated 17 December 2025

What this trial tests

Phase 1/Phase 2 trial testing Ivaltinostat in Metastatic Pancreatic Adenocarcinoma in 70 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 August 2022

Primary endpoint
1 June 2026

1 July 2026

Quick facts

Lead sponsor	CG Pharmaceuticals, Inc
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	15 August 2022
Primary completion	1 June 2026
Estimated completion	1 July 2026
Sites	16 locations across United States

Drugs / interventions tested

• Ivaltinostat — full drug profile →
• Capecitabine (capecitabine) — full drug profile →

Conditions studied

• Metastatic Pancreatic Adenocarcinoma — all drugs for Metastatic Pancreatic Adenocarcinoma →

Sponsor

CG Pharmaceuticals, Inc

Who can join

18 and older, any sex, with Metastatic Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of dose-limiting toxicities (DLTs) in phase 1
  Time frame: 15 months
  The percentage of subjects who experience a grade 3 or higher adverse event that qualifies as a DLT
• Incidence of treatment emergent AEs in phase 1
  Time frame: 15 months
  The number of subjects who experience an adverse event that was possibly related to study drug
• Treatment emergent changes in clinical laboratory tests in phase 1
  Time frame: 15 months
  The number of subjects who experience a change in laboratory parameters that was possibly related to study drug.
• Progression-Free Survival (PFS) in Phase 2
  Time frame: 15 months
  Investigator assessed PFS

Sponsor's own description

This study is a Phase 1b/2, dose-escalation, randomized, multicenter study to assess the efficacy, safety, tolerability, and PK of ivaltinostat in combination with capecitabine and capecitabine monotherapy in patients with metastatic pancreatic adenocarcinoma whose disease has not progressed on a first line fluoropyrimidine-based chemotherapy (e.g., FOLFIRINOX).

In Phase 1b, 3 dose levels of ivaltinostat will be studied in combination with a fixed dose of capecitabine to determine the RP2D of ivaltinostat.

In Phase 2, patients will be randomized in a 1:1 ratio to the combination of ivaltinostat and capecitabine or to capecitabine monotherapy. A fixed dose for capecitabine 1000 mg/m2 orally twice daily will be taken on Days 1 to 14, and the RP2D of ivaltinostat will be administered intravenously once a week for 2 weeks, followed by 1 week of rest. One cycle consists of 21 days. Tumor response during study treatment will be assessed every 6 weeks up to Cycle 10, then every 9 weeks afterwards using RECIST v1.1 criteria.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
2. Pharmacological targeting of the cancer epigenome.
   Mabe NW, Perry JA, Malone CF, Stegmaier K. · · 2024 · cited 36× · PMID 38937652 · DOI 10.1038/s43018-024-00777-2
3. Short-chain acyl post-translational modifications in cancers: Mechanisms, roles, and therapeutic implications.
   Wu T, Zhao Y, Zhang X, Wang Y, et al · · 2025 · cited 23× · PMID 40703012 · DOI 10.1002/cac2.70048
4. Epigenetic control of pancreatic cancer metastasis.
   Krauß L, Schneider C, Hessmann E, Saur D, et al · · 2023 · cited 11× · PMID 37659057 · DOI 10.1007/s10555-023-10132-z
5. The complex role of macrophages in pancreatic cancer tumor microenvironment: a review on cancer progression and potential therapeutic targets.
   Lorestani P, Dashti M, Nejati N, Habibi MA, et al · · 2024 · cited 10× · PMID 39186144 · DOI 10.1007/s12672-024-01256-x
6. Maintenance Treatment for Metastatic Pancreatic Cancer: Balancing Therapeutic Intensity with Tolerable Toxicity.
   Walker EJ, Ko AH. · · 2023 · cited 1× · PMID 37509318 · DOI 10.3390/cancers15143657
7. Processes and therapeutic perspectives of acylation modifications of lysine and cysteine in tumors.
   Jiang J, Chen J, Huang S, Tian Y, et al · · 2026 · PMID 41630001 · DOI 10.1186/s12964-026-02707-4
8. Next-Generation HDAC Inhibitors: Advancing Zinc-Binding Group Design for Enhanced Cancer Therapy.
   Hawash M. · · 2025 · PMID 41440016 · DOI 10.3390/cells14241997