Advanced Solid TumorPhase 1NCT04505839
First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
A Phase 1 study testing STP1002 in people with Advanced Solid Tumor, run by ST Pharm Co., Ltd. at 3 sites in United States.
Trial summary
This is an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- STP1002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jul 2020to 7 Mar 2023
- 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
- Advanced-stage solid tumor (metastatic or locally advanced and unresectable) with histologically confirmed diagnosis of CRC, NSCLC, GC, RCC, or HCC
- Measurable lesion(s) according to RECIST 1.1 criteria
- Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Ability to swallow capsules
- Received last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to first dosing of study treatment
- Has received or is intolerant to all standard of care treatment options with known clinical benefit
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- Life expectancy of more than 3 months
- Adequate hematological, hepatic and renal function
- For women of childbearing potential, a negative serum pregnancy test performed within 7 days prior to start of treatment
Who cannot join
- Received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Major surgery within the last 28 days prior to the first dose of investigational drug
- Prior radiation therapy within 14 days prior to study Cycle 1 Day 1 and/or persistence of radiation-related adverse effects.
- Concurrent treatment with any anticancer agent
- Currently taking either strong CYP inhibitors or inducers
- Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
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- Significant cardiovascular impairment
- Pregnant or nursing
- Known HIV infection, active hepatitis C and/or hepatitis B infection
- Known bleeding disorder or coagulopathy
- Active drug or alcohol abuse or history of alcohol or drug abuse during the last two years.
- Diagnosis of osteoporosis at the time of the screening
- Any history of retinal pathology including diabetic retinopathy, macular degeneration, or other retinal degenerative disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Denver
Denver, Colorado, 80045
Northwestern University
Evanston, Illinois, 60208
University of Southern California
Los Angeles, California, 90033
About this study
This is an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- STP1002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP1002Drug
Also called Basroparib
Oral capsule, QD
| Study group | Role | What they receive |
|---|---|---|
| STP1002 | Experimental | Not described Receives: Drug: STP1002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs)
DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1
Measured: 28 days
Secondary outcomes (2)
Treatment-emergent adverse events (TEAEs)
Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0
Measured: 24 months
The pharmacokinetics of STP1002
Plasma concentration of STP1002 following oral administration
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Jul 2020
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ST Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505839
- Sponsor's protocol ID
- STP-ST-01
- Status last verified
- Jun 2024
- First submitted
- 2 Aug 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
- ClinicalTrials.gov ID
- NCT04505839
- Acronym / sponsor ID
- STP-ST-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ST Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 10 Aug 2020 (actual)
- 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, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STP1002 | Experimental | Drug: STP1002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced-stage solid tumor (metastatic or locally advanced and unresectable) with histologically confirmed diagnosis of CRC, NSCLC, GC, RCC, or HCC
- Measurable lesion(s) according to RECIST 1.1 criteria
- Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Ability to swallow capsules
- Received last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to first dosing of study treatment
Key exclusion criteria (13 listed)
- Received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Major surgery within the last 28 days prior to the first dose of investigational drug
- Prior radiation therapy within 14 days prior to study Cycle 1 Day 1 and/or persistence of radiation-related adverse effects.
- Concurrent treatment with any anticancer agent
- Currently taking either strong CYP inhibitors or inducers
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 |
|---|---|---|
| STP1002Also: BasroparibOral capsule, QD | Drug | STP1002 |
Primary outcome
Dose limiting toxicities (DLTs)
Time frame: 28 days
DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1
2 secondary outcomes
Treatment-emergent adverse events (TEAEs)
Time frame: 24 months
The pharmacokinetics of STP1002
Time frame: 24 months
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 3 Jul 2024.
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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 STP1002 in people with Advanced Solid Tumor, run by ST Pharm Co., Ltd. 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 9 inclusion and 13 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 3 Jul 2024. 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?
Dose limiting toxicities (DLTs) (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 3 Jul 2024.