What side effects are associated with this type of intervention?

Common treatments for bile duct cancer, such as gemcitabine-based regimens, often result in side effects including nausea, vomiting, diarrhea, and neutropenia. Targeted therapies, like monoclonal antibodies similar to TRK-950, can also cause infusion reactions, fatigue, and skin rashes. These side effects are generally manageable but can vary in severity among patients.

What prior FDA approvals exist?

The FDA has approved several treatments for bile duct cancer, including systemic chemotherapies like gemcitabine and cisplatin. Targeted therapies such as pemigatinib, an FGFR inhibitor, have also been approved for patients with specific genetic mutations. While monoclonal antibodies targeting cancer cells, similar to TRK-950, are being studied, there are no specific FDA-approved monoclonal antibody treatments for bile duct cancer as of now.

What other types of research exist?

Promising novel alternatives to TRK-950 for bile duct cancer patients include: 1) FGFR inhibitors such as erdafitinib, which have shown efficacy in cholangiocarcinoma with FGFR2 fusions or rearrangements. 2) Immunotherapy agents like PD-1 inhibitors (nivolumab or pembrolizumab) that can be used alone or in combination with other treatments. 3) Combination regimens such as gemcitabine plus cisplatin, which remain a standard and effective treatment option. 4) Newer targeted agents and combination therapies under investigation in clinical trials, such as those involving novel monoclonal antibodies or kinase inhibitors.

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Small Molecule Inhibitor

TRK-950 Combinations for Ovarian Cancer

Phase 1

Recruiting

Research Sponsored by Toray Industries, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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(Lower-dose)

Must not have

Known active infection with HIV, hepatitis B, hepatitis C

Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, TRK-950, combined with other cancer treatments in patients with advanced cancers. The goal is to see if TRK-950 can help these treatments work better by boosting the body's ability to fight cancer or making cancer cells more vulnerable.

Who is the study for?

This trial is for adults with various advanced solid tumors, including specific types of ovarian, colorectal, and renal cancers. Participants must have measurable tumors and meet criteria for certain treatment regimens based on their cancer type and previous treatments. Pregnant women or those with recent therapies or serious infections are excluded.

What is being tested?

The study tests the safety and optimal dose of TRK-950 in combination with other cancer drugs like FOLFIRI, Gemcitabine/Cisplatin, Ramucirumab/Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), among others. It aims to find effective treatments tailored to different tumor types.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in organs due to PD1 inhibitors; chemotherapy-related issues like nausea, fatigue; skin reactions from Imiquimod Cream; and increased risk of bleeding or hypertension from Bevacizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have renal cell carcinoma and have never been treated with Bevacizumab.

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I have ovarian, peritoneal, or fallopian tube cancer, treated with platinum less than 3 times and it returned more than 6 months after the last treatment.

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My cancer type and history require specific treatments.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

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My tumor can be measured using scans or special tools.

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I have colorectal cancer and have never been treated with Irinotecan or FOLFIRI.

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I have cholangiocarcinoma or bladder cancer and haven't been treated with Gemcitabine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active HIV, hepatitis B, or hepatitis C infection.

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I do not have any health conditions or take any medications that would prevent me from receiving the treatment.

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My lab values do not prevent me from receiving standard cancer treatments.

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I do not have a serious illness that could interfere with the study.

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I do not have any serious infections needing treatment.

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I have severe heart issues, recent heart attack, or unstable heart rhythm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure

Heart rate

Height

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

15Treatment groups

Experimental Treatment

Group I: Arm T: TRK-950 + PaclitaxelExperimental Treatment2 Interventions

* 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

Group II: Arm S: TRK-950 + Carboplatin / PLD/ BevacizumabExperimental Treatment4 Interventions

* 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.

Group III: Arm R: TRK-950 + BevacizumabExperimental Treatment2 Interventions

* 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.

Group IV: Arm Q: TRK-950 + Ramucirumab/PaclitaxelExperimental Treatment3 Interventions

* 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.

Group V: Arm O: TRK-950 + PLDExperimental Treatment2 Interventions

* 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.

Group VI: Arm K: TRK-950 + Gemcitabine / Carboplatin / BevacizumabExperimental Treatment4 Interventions

* 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.

Group VII: Arm J: TRK-950 + FOLFIRIExperimental Treatment4 Interventions

* 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.

Group VIII: Arm H: TRK-950 + PD1 inhibitorsExperimental Treatment3 Interventions

•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.

Group IX: Arm G: TRK-950 + BevacizumabExperimental Treatment2 Interventions

* 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.

Group X: Arm F: TRK-950 + Imiquimod CreamExperimental Treatment2 Interventions

* 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).

Group XI: Arm E: TRK-950 + PD1 inhibitorsExperimental Treatment3 Interventions

•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.

Group XII: Arm D: TRK-950 + Ramucirumab/PaclitaxelExperimental Treatment3 Interventions

* 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.

Group XIII: Arm C: TRK-950 + Gemcitabine/CarboplatinExperimental Treatment3 Interventions

* 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.

Group XIV: Arm B: TRK-950 + Gemcitabine/CisplatinExperimental Treatment3 Interventions

* 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.

Group XV: Arm A: TRK-950 + FOLFIRIExperimental Treatment4 Interventions

* 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Irinotecan

2017

Completed Phase 3

~2590

Bevacizumab

2013

Completed Phase 4

~5540

Nivolumab

2015

Completed Phase 3

~4010

Cisplatin

2013

Completed Phase 3

~3120

Carboplatin

2014

Completed Phase 3

~6120

Ramucirumab

2017

Completed Phase 3

~5050

Imiquimod Cream

2005

N/A

~90

PLD

2015

Completed Phase 3

~1420

Leucovorin

2005

Completed Phase 4

~6010

5-FU

2014

Completed Phase 3

~3100

Paclitaxel

2011

Completed Phase 4

~5450

Pembrolizumab

2017

Completed Phase 3

~3150

TRK-950

2017

Completed Phase 1

~40

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bile duct cancer include chemotherapy, targeted therapies, and monoclonal antibodies like TRK-950. Chemotherapy drugs such as gemcitabine and cisplatin work by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, such as FGFR inhibitors, specifically block molecular pathways that are essential for cancer cell growth and survival. Monoclonal antibodies like TRK-950 target specific antigens on cancer cells, marking them for destruction by the immune system. These mechanisms are crucial for bile duct cancer patients as they offer multiple avenues to attack the cancer, potentially improving treatment efficacy and patient outcomes.

Silmitasertib plus gemcitabine and cisplatin first-line therapy in locally advanced/metastatic cholangiocarcinoma: A Phase 1b/2 study.Dramatic response to dabrafenib and trametinib combination in a BRAF V600E-mutated cholangiocarcinoma: implementation of a molecular tumour board and next-generation sequencing for personalized medicine.Combining biological agents and chemotherapy in the treatment of cholangiocarcinoma.