Locally Advanced or Metastatic Solid CarcinomasPhase 1NCT02990481
A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors
A Phase 1 study testing TRK-950 in people with Locally Advanced or Metastatic Solid Carcinomas and Colon Cancer, run by Toray Industries, Inc at 3 sites in 2 countries.
Trial summary
1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent 2. To establish the dose of TRK-950 recommended for future phase 2 studies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Carcinomas, Colon Cancer, Cholangiocarcinoma
- What is being tested?
- TRK-950
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 Mar 2017to 16 Sep 2019
- 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
- Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
- Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
- Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
- Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
- Measurable disease per RECIST 1.1 (primary or metastases)
Who cannot join
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Pregnant or nursing women
- Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry
- Unwillingness or inability to comply with procedures required in this protocol
- Known active infection with HIV, hepatitis B, hepatitis C
Show all 9Show fewer
- Symptomatic brain metastases
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Patients who are currently receiving any other investigational agent
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Mayo Clinic
Phoenix, Arizona, 85054
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
- To establish the dose of TRK-950 recommended for future phase 2 studies
Read the detailed description
This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.
Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.
In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.
- Being tested
- TRK-950
- Medical subject headings
- Colonic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-950Biological
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
TRK-950Biological
Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle
TRK-950Biological
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - TRK-950 | Experimental | * Solid tumor
* TRK-950 (Three dose levels will be explored during Arm 1) Receives: Biological: TRK-950 |
| Arm 2 - TRK-950 | Experimental | * Colon cancer
* TRK-950 (Low dose and High dose) Receives: Biological: TRK-950 |
| Arm 3 -TRK-950 | Experimental | * Cholangiocarcinomas
* TRK-950 (Low dose) Receives: Biological: TRK-950 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Measured: through study completion, an average of 1 year
CTCAE version 4.03
Measured: through study completion, an average of 1 year
Blood pressure (mmHg)
Measured: through study completion, an average of 1 year
Heart rate (bpm)
Measured: through study completion, an average of 1 year
Respiratory rate (bpm)
Measured: through study completion, an average of 1 year
Temperature (°F or °C)
Measured: through study completion, an average of 1 year
Weight (lbs/kg)
Measured: through study completion, an average of 1 year
Height (inches/cm)
Measured: through study completion, an average of 1 year
Karnofsky performance status
Measured: through study completion, an average of 1 year
Electrocardiogram
Measured: through study completion, an average of 1 year
Clinical laboratory tests
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
Area under the concentration curve(AUC)
Measured: through study completion, an average of 1 year
Maximum plasma concentration(Cmax)
Measured: through study completion, an average of 1 year
Time to maximum plasma concentration(Tmax)
Measured: through study completion, an average of 1 year
Terminal elimination half life(t1/2)
Measured: through study completion, an average of 1 year
Total body clearance(CL)
Measured: through study completion, an average of 1 year
Apparent volume of distribution(Vd)
Measured: through study completion, an average of 1 year
Tumor response rate
Measured: through study completion, an average of 1 year
Duration of response
Measured: through study completion, an average of 1 year
Time to progression
Measured: through study completion, an average of 1 year
Progression free survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start6 Mar 2017
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic Solid CarcinomasStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990481
- Sponsor's protocol ID
- 950P1V01
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2016
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okano F, Saito T, Minamida Y, Kobayashi S, Ido T, Miyauchi Y, Wasai U, Akazawa D, Kume M, Ishibashi M, Jiang K, Aicher A, Heeschen C, Yonehara T. Identification of Membrane-expressed CAPRIN-1 as a Novel and Universal Cancer Target, and Generation of a Therapeutic Anti-CAPRIN-1 Antibody TRK-950. Cancer Res Commun. 2023 Apr 18;3(4):640-658. doi: 10.1158/2767-9764.CRC-22-0310. eCollection 2023 Apr.
PubMed 37082579
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02990481
- Acronym / sponsor ID
- 950P1V01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 13 Dec 2016 (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.
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
- To establish the dose of TRK-950 recommended for future phase 2 studies
Detailed description
This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.
Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.
In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - TRK-950 | Experimental | Biological: TRK-950* Solid tumor * TRK-950 (Three dose levels will be explored during Arm 1) |
| Arm 2 - TRK-950 | Experimental | Biological: TRK-950* Colon cancer * TRK-950 (Low dose and High dose) |
| Arm 3 -TRK-950 | Experimental | Biological: TRK-950* Cholangiocarcinomas * TRK-950 (Low dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
- Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
- Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
- Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
- Measurable disease per RECIST 1.1 (primary or metastases)
Key exclusion criteria (9 listed)
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Pregnant or nursing women
- Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry
- Unwillingness or inability to comply with procedures required in this protocol
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 |
|---|---|---|
| TRK-950Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle | Biological | Arm 1 - TRK-950 |
| TRK-950Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle | Biological | Arm 2 - TRK-950 |
| TRK-950Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle | Biological | Arm 3 -TRK-950 |
Primary outcome
Adverse event
Time frame: through study completion, an average of 1 year
CTCAE version 4.03
Time frame: through study completion, an average of 1 year
Blood pressure (mmHg)
Time frame: through study completion, an average of 1 year
Heart rate (bpm)
Time frame: through study completion, an average of 1 year
Respiratory rate (bpm)
Time frame: through study completion, an average of 1 year
Temperature (°F or °C)
Time frame: through study completion, an average of 1 year
Weight (lbs/kg)
Time frame: through study completion, an average of 1 year
Height (inches/cm)
Time frame: through study completion, an average of 1 year
Karnofsky performance status
Time frame: through study completion, an average of 1 year
Electrocardiogram
Time frame: through study completion, an average of 1 year
Clinical laboratory tests
Time frame: through study completion, an average of 1 year
10 secondary outcomes
Area under the concentration curve(AUC)
Time frame: through study completion, an average of 1 year
Maximum plasma concentration(Cmax)
Time frame: through study completion, an average of 1 year
Time to maximum plasma concentration(Tmax)
Time frame: through study completion, an average of 1 year
Terminal elimination half life(t1/2)
Time frame: through study completion, an average of 1 year
Total body clearance(CL)
Time frame: through study completion, an average of 1 year
Apparent volume of distribution(Vd)
Time frame: through study completion, an average of 1 year
Tumor response rate
Time frame: through study completion, an average of 1 year
Duration of response
Time frame: through study completion, an average of 1 year
Time to progression
Time frame: through study completion, an average of 1 year
Progression free survival
Time frame: through study completion, an average of 1 year
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 16 Apr 2025.
- Derived from this study: PubMed 37082579Okano F, Saito T, Minamida Y, Kobayashi S, Ido T, Miyauchi Y, Wasai U, Akazawa D, Kume M, Ishibashi M, Jiang K, Aicher A, Heeschen C, Yonehara T. Identification of Membrane-expressed CAPRIN-1 as a Novel and Universal Cancer Target, and Generation of a Therapeutic Anti-CAPRIN-1 Antibody TRK-950. Cancer Res Commun. 2023 Apr 18;3(4):640-658. doi: 10.1158/2767-9764.CRC-22-0310. eCollection 2023 Apr.
- Individual participant dataSharing planned: No
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRK-950 in people with Locally Advanced or Metastatic Solid Carcinomas and Colon Cancer, run by Toray Industries, Inc at 3 sites in 2 countries.
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 9 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 16 Apr 2025. 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, France. 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?
Adverse event (time frame: through study completion, an average of 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02990481, which also lists 1 linked publication.
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 16 Apr 2025.