Colorectal CancerPhase 1NCT02191761
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
A Phase 1 study testing SM04755 in people with Colorectal Cancer and Gastric Cancer, run by Biosplice Therapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer, Hepatic Cancer
- What is being tested?
- SM04755
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jun 2014to 20 May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
- Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy
- Subjects must meet certain laboratory criteria
- Expected survival > 3months
- Subjects must have no uncontrolled intercurrent illness
Who cannot join
- Women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method
- Subjects with significant cardiac issues
- Subjects using certain medications
- Subjects with certain medical conditions
- Subjects with brain metastasis
- Subjects who have recently been enrolled in other experimental clinical trials of investigational agents
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Houston, Texas, 77030
Study site
La Jolla, California, 92121
Study site
Scottsdale, Arizona, 85258
About this study
Official title: Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the 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 maximum tolerated dose (MTD), expansion cohorts may be enrolled.
- Conditions
- Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer
- Being tested
- SM04755
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM04755Drug
Escalating Doses
| Study group | Role | What they receive |
|---|---|---|
| SM04755 | Experimental | Not described Receives: Drug: SM04755 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD
Measured: 28 days
Secondary outcomes (9)
Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings
Measured: 28 days
Area under the plasma concentration (AUC) Versus Time Curve of SM04755
Measured: 30 days
Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 8 weeks
Maximum Observed Plasma Concentration (Cmax) of SM04755
Measured: 30 Days
Half Life of SM04755
Measured: 30 Days
Volume of Distribution of SM04755
Measured: 30 Days
Time to maximum plasma concentration
Measured: 30 Days
Accumulation ratio of SM04755
Measured: 30 Days
Total Clearance of SM04755 after oral administration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start19 Jun 2014
- Primary completion20 May 2015
- Study completion20 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191761
- Sponsor's protocol ID
- SM04755-ONC-01
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2014
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02191761
- Acronym / sponsor ID
- SM04755-ONC-01
- Conditions
- Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2014 (actual)
- Primary completion
- 20 May 2015 (actual)
- Study completion
- 20 May 2015 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SM04755 | Experimental | Drug: SM04755 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
- Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy
- Subjects must meet certain laboratory criteria
- Expected survival > 3months
- Subjects must have no uncontrolled intercurrent illness
Key exclusion criteria (6 listed)
- Women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method
- Subjects with significant cardiac issues
- Subjects using certain medications
- Subjects with certain medical conditions
- Subjects with brain metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM04755Escalating Doses | Drug | SM04755 |
Primary outcome
Determine the MTD
Time frame: 28 days
9 secondary outcomes
Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings
Time frame: 28 days
Area under the plasma concentration (AUC) Versus Time Curve of SM04755
Time frame: 30 days
Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 8 weeks
Maximum Observed Plasma Concentration (Cmax) of SM04755
Time frame: 30 Days
Half Life of SM04755
Time frame: 30 Days
Volume of Distribution of SM04755
Time frame: 30 Days
Time to maximum plasma concentration
Time frame: 30 Days
Accumulation ratio of SM04755
Time frame: 30 Days
Total Clearance of SM04755 after oral administration
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SM04755 in people with Colorectal Cancer and Gastric Cancer, run by Biosplice Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the MTD (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.