~29 spots leftby Jun 2026

TRK-950 Combinations for Ovarian Cancer

Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Toray Industries, Inc
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are currently receiving any other investigational agent or if your medications are contraindicated with the trial's treatment regimens. It's best to discuss your specific medications with the trial team.

What data supports the idea that TRK-950 Combinations for Ovarian Cancer is an effective treatment?

The available research does not provide specific data on the effectiveness of TRK-950 Combinations for Ovarian Cancer. However, it highlights the importance of combination therapies in treating ovarian cancer, which target multiple cancer pathways to improve outcomes. Other studies mention the effectiveness of different drug combinations, such as carboplatin with adavosertib for certain ovarian cancer types, and the synergy of panobinostat with other drugs in cell lines. These findings suggest that combining different treatments can be beneficial, but specific data on TRK-950 is not provided.12345

What safety data is available for TRK-950 combinations in ovarian cancer treatment?

The safety data for TRK-950 combinations in ovarian cancer treatment is not directly mentioned in the provided research abstracts. However, the abstracts discuss the safety and efficacy of various antineoplastic agents and combinations, such as platinum-based chemotherapy, paclitaxel, and bevacizumab, which are commonly used in ovarian cancer treatment. For example, a Phase I trial combining ribociclib with carboplatin and paclitaxel reported common adverse events like anemia, neutropenia, fatigue, and nausea, indicating the safety profile of such combinations. Additionally, the use of bevacizumab in combination with chemotherapy has shown a positive effect in large phase III trials. These findings suggest that while specific safety data for TRK-950 is not detailed, the safety of similar combination therapies has been evaluated in clinical settings.678910

Is the drug TRK-950 a promising treatment for ovarian cancer?

Yes, TRK-950 is a promising drug for ovarian cancer because it is part of new combination therapies that target multiple cancer pathways, potentially improving treatment outcomes.56111213

Research Team

Eligibility Criteria

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.

Inclusion Criteria

You are expected to live for at least 3 more months.
I have renal cell carcinoma and have never been treated with Bevacizumab.
I have gastric cancer and haven't been treated with Ramucirumab or any Taxane.
See 11 more

Exclusion Criteria

I have recently undergone treatment such as radiation, surgery, or chemotherapy.
I do not have an active HIV, hepatitis B, or hepatitis C infection.
Current treatment with any other investigational agent
See 7 more

Treatment Details

Interventions

  • 5-FU (Chemotherapy Agent)
  • Bevacizumab (Monoclonal Antibodies)
  • Carboplatin (Chemotherapy Agent)
  • Cisplatin (Chemotherapy Agent)
  • Gemcitabine (Chemotherapy Agent)
  • Imiquimod Cream (Immunomodulator)
  • Irinotecan (Chemotherapy Agent)
  • Leucovorin (Chemotherapy Agent)
  • Nivolumab (Checkpoint Inhibitor)
  • Paclitaxel (Chemotherapy Agent)
  • Pembrolizumab (Checkpoint Inhibitor)
  • PLD (Chemotherapy Agent)
  • Ramucirumab (Monoclonal Antibodies)
  • Topotecan (Chemotherapy Agent)
  • TRK-950 (Small Molecule Inhibitor)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Toray Industries, Inc

Lead Sponsor

Trials
22
Recruited
2,400+
Headquarters
Japan
Known For
Gene Therapies
Top Products
FERON™, DORNER™, REMITCH™

Findings from Research

The combination of carboplatin and adavosertib was found to be safe and effective in treating patients with TP53 mutated platinum-resistant ovarian cancer, showing an objective response rate of 41% among 29 evaluable patients.
Despite its efficacy, the treatment was associated with significant bone marrow toxicity, which was the most common reason for dose reductions and delays, highlighting a safety concern that needs to be managed.
WEE1 inhibitor adavosertib in combination with carboplatin in advanced TP53 mutated ovarian cancer: A biomarker-enriched phase II study.Embaby, A., Kutzera, J., Geenen, JJ., et al.[2023]
Patients with recurrent ovarian cancer are categorized as either platinum-sensitive or platinum-resistant, which influences treatment options; platinum-sensitive patients often benefit from re-treatment with paclitaxel/platinum combinations, while platinum-resistant patients may receive single-agent therapies like altretamine or topotecan.
For platinum-sensitive patients with minimal residual disease, intensive intraperitoneal therapy with cisplatin and paclitaxel shows the most promise for long-term disease-free survival, highlighting the importance of tailored treatment strategies based on disease characteristics.
Treatment of refractory and recurrent ovarian cancer.Alberts, DS.[2005]
Panobinostat, a histone deacetylase inhibitor, shows significant synergy with gemcitabine and paclitaxel, and particularly strong synergistic effects when combined with doxorubicin and carboplatin in treating metastatic ovarian cancer cell lines.
The study utilized in vitro assays on three ovarian cancer cell lines (SK-OV3, CaOV-3, and ES-2) to identify effective drug combinations, suggesting that these combinations could enhance treatment efficacy and warrant further clinical investigation.
The histone deacetylase inhibitor panobinostat demonstrates marked synergy with conventional chemotherapeutic agents in human ovarian cancer cell lines.Budman, DR., Tai, J., Calabro, A., et al.[2021]

References

WEE1 inhibitor adavosertib in combination with carboplatin in advanced TP53 mutated ovarian cancer: A biomarker-enriched phase II study. [2023]
Treatment of refractory and recurrent ovarian cancer. [2005]
The histone deacetylase inhibitor panobinostat demonstrates marked synergy with conventional chemotherapeutic agents in human ovarian cancer cell lines. [2021]
The Drug Combination of SB202190 and SP600125 Significantly Inhibit the Growth and Metastasis of Olaparib-resistant Ovarian Cancer Cell. [2018]
Strategic Combination Therapies for Ovarian Cancer. [2021]
Innovative therapies for advanced ovarian cancer. [2012]
New, expanded, and modified use of approved antineoplastic agents in ovarian cancer. [2007]
Phase I trial of ribociclib with platinum chemotherapy in ovarian cancer. [2022]
Ovarian cancer: new strategies and emerging targets for the treatment of patients with advanced disease. [2023]
Optimal first-line treatment in ovarian cancer. [2022]
Challenges for immunotherapy for the treatment of platinum resistant ovarian cancer. [2022]
[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. [2008]
Extending the platinum-free interval in recurrent ovarian cancer: the role of topotecan in second-line chemotherapy. [2022]