Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02191761 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer

A Phase 1 study, sponsored by Biosplice Therapeutics.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT02191761: Completed Phase 1 study, sponsored by Biosplice Therapeutics.

NCT02191761 is a Phase 1 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02191761, a Phase 1 study, has completed, sponsored by Biosplice Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.

Interventions

  • DRUG SM04755

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2014-06-19
Est. Completion 2015-05-20
Phase Phase 1
Biosplice Therapeutics

20 total trials

What the finished NCT02191761 record still lists

NCT02191761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 1 intervention - of which SM04755 is the first listed.

NCT02191761 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02191761 about?

NCT02191761 is a clinical study titled "Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer". This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the ma...

What is the current status of trial NCT02191761?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-06-19. Estimated completion is 2015-05-20.

What interventions are being tested in trial NCT02191761?

The interventions under investigation include: SM04755 (DRUG).

Who is sponsoring clinical trial NCT02191761?

This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02191761's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03125655 · 13 participants

    Regulation of Inflammatory Genes in Psoriasis

  • NCT03774446 · 13 participants · Phase 2

    Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease

  • NCT03830151 · 13 participants · Phase 1

    Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

  • NCT04573231 · 13 participants · Phase 2

    Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT02191761, the US trial registry maintained by the National Library of Medicine. NCT02191761 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.