Solid TumorPhase 1NCT03872947

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

A Phase 1 study testing TRK-950, Irinotecan and Leucovorin in people with Solid Tumor and Colorectal Cancer, run by Toray Industries, Inc at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin /… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Colorectal Cancer, Cholangiocarcinoma
What is being tested?: TRK-950, Irinotecan and Leucovorin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 14 sitesin 2 countries
Study dates: 26 Apr 2019to 16 Jul 2026
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

Histologically confirmed solid malignancy for which the following treatment regimens are warranted:
Arm A. Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care
Arm B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: Gemcitabine / Cisplatin as standard of care
Arm C. Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy and have no prior history of treatment with gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of care
Arm D. Gastric Cancer including Gastroesophageal Junction with no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug: Ramucirumab / Paclitaxel as standard of care
Arm E. Solid Tumors: Eligible for PD1 Inhibitor (Nivolumab or Pembrolizumab) monotherapy as standard of care according to the approved drug label by the relevant regulatory authority

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Arm F. Locally advanced or metastatic disease in a cancer with at least one palpable subcutaneous malignant lesion (≤ 2 cm in diameter) for treatment with TRK-950 and Imiquimod cream (US Sites Only)
Arm G. Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment
Arm H. Melanoma patients who progressed while taking Nivolumab, Pembrolizumab, or Ipilimumab, within the last 6 months prior to cycle 1 day 1
Arm J. Colorectal Cancer patients who progressed on FOLFIRI or any other Irinotecan-containing therapy regimen within the last 6 months prior to cycle 1 day 1
Arm K. (US Sites Only). Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 6 months after most recent platinum-based chemotherapy and who are eligible for gemcitabine, carboplatin, and Bevacizumab as standard of care for dosing of TRK-950
Arm O. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, as defined below and who are eligible for topotecan or pegylated liposomal doxorubicin as standard of care for dosing of TRK-950
Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response, and then progressed between 3 months and less than or equal to 6 months after the last date of platinum.
Patients who have received 2 to 5 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum.
Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
Arm Q. Gastric Cancer including GEJ cancer with only 1 prior treatment regimen, which recurred during or within 4 months after frontline treatment, and no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of care
Arm R. Clear cell renal cell carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment.
Arm S. Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 182 days after most recent platinum-based chemotherapy and who are eligible for carboplatin, PLD, and bevacizumab as standard of care
The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS)
Patients with or without the breast cancer susceptibility 1/2 (BRCA1/2) mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment
Arm T. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, or as defined below, and who are eligible for paclitaxel as standard of care
Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (complete response/remission (CR) or partial response/remission (PR), and then progressed between 90 days to less than 183 days after the last date of platinum.
Patients who have received multiple lines of platinum therapy must have progressed on the latest platinum, or within 183 days after the date of the last dose of the latest platinum
Patients with or without the BRCA1/2 mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment
Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS)
Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions)
Karnofsky performance of ≥70
Life expectancy of at least 3 months
Age ≥ 18 years
Signed, written IRB-approved informed consent

Who cannot join

Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens
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. Prophylactic antibiotics are acceptable.
Pregnant or nursing women
Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, targeted therapy or investigational therapy within four weeks prior to initiation of study treatment (6 weeks for nitrosoureas or mitomycin C, and 2 weeks or 5 half-lives whichever is longer for TKIs).
Unwillingness or inability to comply with procedures required in this protocol

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Known active infection with HIV, hepatitis B, hepatitis C
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
Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen that is to be used in combination with TRK-950 (for example, autoimmune disorders for nivolumab or pembrolizumab treatment) as described in the Full Prescribing Information

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States13 sites

Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center)
Eugene, Oregon, 97401
Texas Oncology - Downtown Fort Worth Cancer Center
Fort Worth, Texas, 76104
Virginia Cancer Specialists, PC
Leesburg, Virginia, 20176
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Atlantic Health System
Morristown, New Jersey, 07960
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
HOAG Memorial Hospital Presbyterian
Newport, California, 92663
Northwest Cancer Specialists
Portland, Oregon, 97227
HonorHealth Research Institute
Scottsdale, Arizona, 85258
AOA-HOPE
Tucson, Arizona, 85711

Other trials in United States

France1 site

Centre Léon Bérard
Lyon, 69373

Other trials in France

About this study

Official title: A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors

Read the detailed description

This study is an open-label, Phase 1b study evaluating TRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions 7) Bevacizumab 8) Gemcitabine / Carboplatin / Bevacizumab, 9)PLD, 10) Carboplatin / PLD / Bevacizumab or 11) Paclitaxel in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.

Conditions: Solid Tumor, Colorectal Cancer, Cholangiocarcinoma, Bladder Cancer, Ovarian Cancer, Gastric Cancer
Being tested: TRK-950, Irinotecan, Leucovorin, 5-FU, Gemcitabine
Medical subject headings: Colorectal Neoplasms, Cholangiocarcinoma, Urinary Bladder Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Carcinoma, Renal Cell, Melanoma, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRK-950Biological
10 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950Biological
5 mg/kg administered intravenously over 60 minutes (weekly)
TRK-950Biological
Treatment Phase: 20 mg/kg administered intravenously over 60 minutes (bi-weekly) Maintenance Phase: 30 mg/kg administered intravenously over 60 minutes (every 3 weeks)
IrinotecanDrug
Intravenously over 30 - 90 minutes
LeucovorinDrug
Intravenously over 30 - 90 minutes
5-FUDrug
Intravenously bolus and intravenously for two days
GemcitabineDrug
Intravenously over 30 minutes
CisplatinDrug
Intravenously over 60 minutes
CarboplatinDrug
Intravenously per package insert
RamucirumabDrug
Intravenously over 60 minutes
PaclitaxelDrug
Intravenously
NivolumabDrug
Intravenously over 30 minutes
PembrolizumabDrug
Intravenously over 30 minutes
Imiquimod CreamDrug
Topically
BevacizumabDrug
Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses
PLDDrug
Intravenously over 60 minutes

Study groups in NCT03872947
Study group	Role	What they receive
Arm A: TRK-950 + FOLFIRI	Experimental	* Colorectal Cancer * TRK-950 will be administered intravenously (IV) on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion. Receives: Biological: TRK-950; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-FU
Arm B: TRK-950 + Gemcitabine/Cisplatin	Experimental	* Cholangiocarcinoma or Bladder Cancer * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Cisplatin will be administered by infusion. Then, Gemcitabine will be administered as an IV infusion. Receives: Biological: TRK-950; Drug: Gemcitabine; Drug: Cisplatin
Arm C: TRK-950 + Gemcitabine/Carboplatin	Experimental	* Ovarian Cancer * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Gemcitabine will be administered as an intravenous infusion. On day 1, following the administration of TRK-950 and Gemcitabine, Carboplatin will be administered IV. Receives: Biological: TRK-950; Drug: Gemcitabine; Drug: Carboplatin
Arm D: TRK-950 + Ramucirumab/Paclitaxel	Experimental	* Gastric Cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Ramucirumab will be administered as an IV infusion. Paclitaxel will be dosed on days 1, 8 and 15, after the Ramucirumab on days 1 and 15 and after the TRK-950 on day 8. Receives: Biological: TRK-950; Drug: Ramucirumab; Drug: Paclitaxel
Arm E: TRK-950 + PD1 inhibitors	Experimental	•Solid Tumors E-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. E-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion. Receives: Biological: TRK-950; Drug: Nivolumab; Drug: Pembrolizumab
Arm F: TRK-950 + Imiquimod Cream	Experimental	* Palpable subcutaneous malignant lesions * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks). Receives: Biological: TRK-950; Drug: Imiquimod Cream
Arm G: TRK-950 + Bevacizumab	Experimental	* Renal Cell Carcinoma * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Bevacizumab will be administered as an IV infusion. Receives: Biological: TRK-950; Drug: Bevacizumab
Arm H: TRK-950 + PD1 inhibitors	Experimental	•Melanoma H-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. H-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion. Receives: Biological: TRK-950; Drug: Nivolumab; Drug: Pembrolizumab
Arm J: TRK-950 + FOLFIRI	Experimental	* Colorectal Cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion. Receives: Biological: TRK-950; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-FU
Arm K: TRK-950 + Gemcitabine / Carboplatin / Bevacizumab	Experimental	* Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. Gemcitabine will be administered as an intravenous infusion on days 1 and 8. On day 1, following the administration of Gemcitabine, Carboplatin will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. After 6 cycles of chemotherapy the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease. Receives: Biological: TRK-950; Drug: Gemcitabine; Drug: Carboplatin; Drug: Bevacizumab
Arm O: TRK-950 + PLD	Experimental	* Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. PLD will be dosed as IV on Day 1 of each cycle. On days that TRK-950 and PLD are both dosed, PLD will be dosed first. Receives: Biological: TRK-950; Drug: PLD
Arm Q: TRK-950 + Ramucirumab/Paclitaxel	Experimental	* Gastric cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. On days 1 and 15, ramucirumab will be administered IV. Paclitaxel will be dosed on days 1, 8 and 15, after ramucirumab on days 1 and 15, before TRK-950 on day 8. Receives: Biological: TRK-950; Drug: Ramucirumab; Drug: Paclitaxel
Arm R: TRK-950 + Bevacizumab	Experimental	* Renal cell carcinoma cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. Bevacizumab will be dosed as IV on Day 1 and 15 of each cycle. On days that TRK-950 and Bevacizumab are both dosed, Bevacizumab will be dosed first. Receives: Biological: TRK-950; Drug: Bevacizumab
Arm S: TRK-950 + Carboplatin / PLD/ Bevacizumab	Experimental	* Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer * Treatment Phase: TRK-950 will be administered IV on days 1 and 15 of a 28-day cycle. Carboplatin will be administered as an intravenous infusion on day 1. On day 1, following the administration of Carboplatin, PLD will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. On days 1 and 15, TRK-950 will be administered IV after the Bevacizumab infusion. • Maintenance Phase: After 6 cycles of chemotherapy, the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Following the Bevacizumab administration, TRK-950 will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease. Receives: Biological: TRK-950; Drug: Carboplatin; Drug: Bevacizumab; Drug: PLD
Arm T: TRK-950 + Paclitaxel	Experimental	* Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1, 8 and 15 of each cycle, Paclitaxel will be dosed on IV Receives: Biological: TRK-950; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0
Measured: through study completion, an average of 1 year
Frequency of patients experiencing adverse events of special interest (AESIs)
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
Performance status using Karnofsky performance status criteria
Measured: through study completion, an average of 1 year
QTc interval determined from 12-lead Electrocardiogram
msec
Measured: through study completion, an average of 1 year
QRS interval determined from 12-lead Electrocardiogram
msec
Measured: through study completion, an average of 1 year
Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry)
Measured: through study completion, an average of 1 year

Secondary outcomes (10)

Overall response rate (ORR)
Measured: through study completion, an average of 1 year
Disease Control Rate (DCR)
Measured: through study completion, an average of 1 year
Serum concentration of TRK-950
Measured: through study completion, an average of 1 year
Plasma concentration of Gemcitabine for the first six patients in Arm K
Measured: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Plasma concentration of Carboplatin for the first six patients in Arm K
Measured: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Serum concentration of Bevacizumab for the first six patients in Arm K
Measured: At the beginning of Cycle 1, Cycle 2, Cycle 4 and Cycle 5 (each cycle is 21 days)
Plasma concentration of PLD for the first six patients in Arm O
Measured: At the beginning and middle of Cycle 1 and Cycle 3 (each cycle is 28 days)
Serum concentration of Ramucirumab for the first six patients in Arm Q
Measured: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)
Plasma concentration of Paclitaxel for the first six patients in Arm Q
Measured: At the beginning of Cycle 1 and Cycle 4 (each cycle is 28 days)
Serum concentration of Bevacizumab for the first six patients in Arm R
Measured: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 201916 Jul 2026

First posted13 Mar 2019
Study start26 Apr 2019
Primary completion16 Jul 2026
Study completion16 Jul 2026

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 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03872947
Sponsor's protocol ID: 950P1V02
Status last verified: Oct 2026
First submitted: 7 Mar 2019
Last updated: 8 Oct 2026
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03872947
Acronym / sponsor ID: 950P1V02
Conditions: Solid Tumor, Colorectal Cancer, Cholangiocarcinoma, Bladder Cancer, Ovarian Cancer, Gastric Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Toray Industries, IncIndustry (pharma, biotech, devices)
Study start: 26 Apr 2019 (actual)
Primary completion: 16 Jul 2026 (actual)
Study completion: 16 Jul 2026 (actual)
First posted: 13 Mar 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 15

Arm	Type	Receives
Arm A: TRK-950 + FOLFIRI	Experimental	Biological: TRK-950, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-FU* Colorectal Cancer * TRK-950 will be administered intravenously (IV) on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
Arm B: TRK-950 + Gemcitabine/Cisplatin	Experimental	Biological: TRK-950, Drug: Gemcitabine, Drug: Cisplatin* Cholangiocarcinoma or Bladder Cancer * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Cisplatin will be administered by infusion. Then, Gemcitabine will be administered as an IV infusion.
Arm C: TRK-950 + Gemcitabine/Carboplatin	Experimental	Biological: TRK-950, Drug: Gemcitabine, Drug: Carboplatin* Ovarian Cancer * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Gemcitabine will be administered as an intravenous infusion. On day 1, following the administration of TRK-950 and Gemcitabine, Carboplatin will be administered IV.
Arm D: TRK-950 + Ramucirumab/Paclitaxel	Experimental	Biological: TRK-950, Drug: Ramucirumab, Drug: Paclitaxel* Gastric Cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Ramucirumab will be administered as an IV infusion. Paclitaxel will be dosed on days 1, 8 and 15, after the Ramucirumab on days 1 and 15 and after the TRK-950 on day 8.
Arm E: TRK-950 + PD1 inhibitors	Experimental	Biological: TRK-950, Drug: Nivolumab, Drug: Pembrolizumab•Solid Tumors E-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. E-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.
Arm F: TRK-950 + Imiquimod Cream	Experimental	Biological: TRK-950, Drug: Imiquimod Cream* Palpable subcutaneous malignant lesions * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks).
Arm G: TRK-950 + Bevacizumab	Experimental	Biological: TRK-950, Drug: Bevacizumab* Renal Cell Carcinoma * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Bevacizumab will be administered as an IV infusion.
Arm H: TRK-950 + PD1 inhibitors	Experimental	Biological: TRK-950, Drug: Nivolumab, Drug: Pembrolizumab•Melanoma H-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. H-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.
Arm J: TRK-950 + FOLFIRI	Experimental	Biological: TRK-950, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-FU* Colorectal Cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
Arm K: TRK-950 + Gemcitabine / Carboplatin / Bevacizumab	Experimental	Biological: TRK-950, Drug: Gemcitabine, Drug: Carboplatin, Drug: Bevacizumab* Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer * TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. Gemcitabine will be administered as an intravenous infusion on days 1 and 8. On day 1, following the administration of Gemcitabine, Carboplatin will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. After 6 cycles of chemotherapy the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.
Arm O: TRK-950 + PLD	Experimental	Biological: TRK-950, Drug: PLD* Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. PLD will be dosed as IV on Day 1 of each cycle. On days that TRK-950 and PLD are both dosed, PLD will be dosed first.
Arm Q: TRK-950 + Ramucirumab/Paclitaxel	Experimental	Biological: TRK-950, Drug: Ramucirumab, Drug: Paclitaxel* Gastric cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. On days 1 and 15, ramucirumab will be administered IV. Paclitaxel will be dosed on days 1, 8 and 15, after ramucirumab on days 1 and 15, before TRK-950 on day 8.
Arm R: TRK-950 + Bevacizumab	Experimental	Biological: TRK-950, Drug: Bevacizumab* Renal cell carcinoma cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. Bevacizumab will be dosed as IV on Day 1 and 15 of each cycle. On days that TRK-950 and Bevacizumab are both dosed, Bevacizumab will be dosed first.
Arm S: TRK-950 + Carboplatin / PLD/ Bevacizumab	Experimental	Biological: TRK-950, Drug: Carboplatin, Drug: Bevacizumab, Drug: PLD* Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer * Treatment Phase: TRK-950 will be administered IV on days 1 and 15 of a 28-day cycle. Carboplatin will be administered as an intravenous infusion on day 1. On day 1, following the administration of Carboplatin, PLD will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. On days 1 and 15, TRK-950 will be administered IV after the Bevacizumab infusion. • Maintenance Phase: After 6 cycles of chemotherapy, the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Following the Bevacizumab administration, TRK-950 will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.
Arm T: TRK-950 + Paclitaxel	Experimental	Biological: TRK-950, Drug: Paclitaxel* Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer * TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1, 8 and 15 of each cycle, Paclitaxel will be dosed on IV

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

Histologically confirmed solid malignancy for which the following treatment regimens are warranted:
Arm A. Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care
Arm B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: Gemcitabine / Cisplatin as standard of care
Arm C. Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy and have no prior history of treatment with gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of care
Arm D. Gastric Cancer including Gastroesophageal Junction with no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug: Ramucirumab / Paclitaxel as standard of care

Key exclusion criteria (10 listed)

Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens
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. Prophylactic antibiotics are acceptable.
Pregnant or nursing women
Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, targeted therapy or investigational therapy within four weeks prior to initiation of study treatment (6 weeks for nitrosoureas or mitomycin C, and 2 weeks or 5 half-lives whichever is longer for TKIs).

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-95010 mg/kg administered intravenously over 60 minutes (weekly)	Biological	Arm A: TRK-950 + FOLFIRI, Arm B: TRK-950 + Gemcitabine/Cisplatin, Arm C: TRK-950 + Gemcitabine/Carboplatin, Arm D: TRK-950 + Ramucirumab/Paclitaxel, Arm E: TRK-950 + PD1 inhibitors, Arm F: TRK-950 + Imiquimod Cream, Arm G: TRK-950 + Bevacizumab, Arm H: TRK-950 + PD1 inhibitors, Arm J: TRK-950 + FOLFIRI, Arm T: TRK-950 + Paclitaxel
TRK-9505 mg/kg administered intravenously over 60 minutes (weekly)	Biological	Arm K: TRK-950 + Gemcitabine / Carboplatin / Bevacizumab, Arm O: TRK-950 + PLD, Arm Q: TRK-950 + Ramucirumab/Paclitaxel, Arm R: TRK-950 + Bevacizumab
TRK-950Treatment Phase: 20 mg/kg administered intravenously over 60 minutes (bi-weekly) Maintenance Phase: 30 mg/kg administered intravenously over 60 minutes (every 3 weeks)	Biological	Arm S: TRK-950 + Carboplatin / PLD/ Bevacizumab
IrinotecanIntravenously over 30 - 90 minutes	Drug	Arm A: TRK-950 + FOLFIRI, Arm J: TRK-950 + FOLFIRI
LeucovorinIntravenously over 30 - 90 minutes	Drug	Arm A: TRK-950 + FOLFIRI, Arm J: TRK-950 + FOLFIRI
5-FUIntravenously bolus and intravenously for two days	Drug	Arm A: TRK-950 + FOLFIRI, Arm J: TRK-950 + FOLFIRI
GemcitabineIntravenously over 30 minutes	Drug	Arm B: TRK-950 + Gemcitabine/Cisplatin, Arm C: TRK-950 + Gemcitabine/Carboplatin, Arm K: TRK-950 + Gemcitabine / Carboplatin / Bevacizumab
CisplatinIntravenously over 60 minutes	Drug	Arm B: TRK-950 + Gemcitabine/Cisplatin
CarboplatinIntravenously per package insert	Drug	Arm C: TRK-950 + Gemcitabine/Carboplatin, Arm K: TRK-950 + Gemcitabine / Carboplatin / Bevacizumab, Arm S: TRK-950 + Carboplatin / PLD/ Bevacizumab
RamucirumabIntravenously over 60 minutes	Drug	Arm D: TRK-950 + Ramucirumab/Paclitaxel, Arm Q: TRK-950 + Ramucirumab/Paclitaxel
PaclitaxelIntravenously	Drug	Arm D: TRK-950 + Ramucirumab/Paclitaxel, Arm Q: TRK-950 + Ramucirumab/Paclitaxel, Arm T: TRK-950 + Paclitaxel
NivolumabIntravenously over 30 minutes	Drug	Arm E: TRK-950 + PD1 inhibitors, Arm H: TRK-950 + PD1 inhibitors
PembrolizumabIntravenously over 30 minutes	Drug	Arm E: TRK-950 + PD1 inhibitors, Arm H: TRK-950 + PD1 inhibitors
Imiquimod CreamTopically	Drug	Arm F: TRK-950 + Imiquimod Cream
BevacizumabIntravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses	Drug	Arm G: TRK-950 + Bevacizumab, Arm K: TRK-950 + Gemcitabine / Carboplatin / Bevacizumab, Arm R: TRK-950 + Bevacizumab, Arm S: TRK-950 + Carboplatin / PLD/ Bevacizumab
PLDIntravenously over 60 minutes	Drug	Arm O: TRK-950 + PLD, Arm S: TRK-950 + Carboplatin / PLD/ Bevacizumab

Primary outcome

Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 1 year
Frequency of patients experiencing adverse events of special interest (AESIs)
Time frame: through study completion, an average of 1 year
Blood pressure
Time frame: through study completion, an average of 1 year
mmHg
Heart rate
Time frame: through study completion, an average of 1 year
bpm
Respiratory rate
Time frame: through study completion, an average of 1 year
bpm
Temperature
Time frame: through study completion, an average of 1 year
°F or °C
Weight
Time frame: through study completion, an average of 1 year
lbs/kg
Height
Time frame: through study completion, an average of 1 year
inches/cm
Performance status using Karnofsky performance status criteria
Time frame: through study completion, an average of 1 year
QTc interval determined from 12-lead Electrocardiogram
Time frame: through study completion, an average of 1 year
msec
QRS interval determined from 12-lead Electrocardiogram
Time frame: through study completion, an average of 1 year
msec
Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry)
Time frame: through study completion, an average of 1 year

10 secondary outcomes

Overall response rate (ORR)
Time frame: through study completion, an average of 1 year
Disease Control Rate (DCR)
Time frame: through study completion, an average of 1 year
Serum concentration of TRK-950
Time frame: through study completion, an average of 1 year
Plasma concentration of Gemcitabine for the first six patients in Arm K
Time frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Plasma concentration of Carboplatin for the first six patients in Arm K
Time frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Serum concentration of Bevacizumab for the first six patients in Arm K
Time frame: At the beginning of Cycle 1, Cycle 2, Cycle 4 and Cycle 5 (each cycle is 21 days)
Plasma concentration of PLD for the first six patients in Arm O
Time frame: At the beginning and middle of Cycle 1 and Cycle 3 (each cycle is 28 days)
Serum concentration of Ramucirumab for the first six patients in Arm Q
Time frame: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)
Plasma concentration of Paclitaxel for the first six patients in Arm Q
Time frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 28 days)
Serum concentration of Bevacizumab for the first six patients in Arm R
Time frame: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 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 8 Oct 2026.
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.

14 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, Irinotecan and Leucovorin in people with Solid Tumor and Colorectal Cancer, run by Toray Industries, Inc at 14 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 31 inclusion and 10 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 8 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 14 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?

Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0 (time frame: through study completion, an average of 1 year). The study lists 12 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 NCT03872947, 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 8 Oct 2026.