70 Participants Needed

TORL-4-500 for Advanced Cancer

Recruiting at 9 trial locations
SL
BS
CL
Overseen ByCaroline Labib, PharmD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: TORL Biotherapeutics, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial requires that you have not received any chemotherapeutic, investigational, or other therapies for cancer within 14 days for small molecule drugs and 28 days for biologic drugs before starting the trial. It does not specify other medications, so you may need to discuss with the trial team.

What data supports the effectiveness of the drug TORL-4-500 for advanced cancer?

The JUPITER-06 trial showed that toripalimab, an immune checkpoint inhibitor, combined with chemotherapy improved survival in patients with advanced esophageal cancer, suggesting that similar treatments may be effective for other advanced cancers.12345

What safety data exists for TORL-4-500 or similar treatments in humans?

The safety profiles of drugs for advanced melanoma, including targeted therapies, show common side effects like skin issues and endocrine disorders. Serious adverse effects can occur with cancer therapies, sometimes requiring intensive care. It's important to have healthcare professionals manage these complications.678910

What makes the drug TORL-4-500 unique for advanced cancer treatment?

The drug TORL-4-500 is unique because it may offer a novel approach to treating advanced cancer by potentially targeting specific pathways or mechanisms that are not addressed by current standard treatments, such as CDK 4/6 inhibitors or m-TOR inhibitors, which are commonly used in hormone receptor-positive, HER2-negative breast cancer. This could provide new options for patients who have developed resistance to existing therapies.1112131415

What is the purpose of this trial?

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).

Research Team

CL

Caroline Labib, PharmD

Principal Investigator

TORL Biotherapeutics, LLC

Eligibility Criteria

This trial is for adults with advanced solid tumors, including liver cancer, who have measurable disease and are in good physical condition (ECOG 0-1). They must have proper organ function and not be recovering from severe side effects of previous treatments. People with brain metastases, significant heart issues, recent cancer therapies, uncontrolled diseases or infections, a history of certain blood disorders or another cancer within the last three years cannot join.

Inclusion Criteria

I am fully active or can carry out light work.
My organs are working well.
My cancer is in an advanced stage and not just in one place.
See 1 more

Exclusion Criteria

I have a history of serious heart problems.
I had cancer before, but it's been a while.
I have not had cancer treatment within the specified time before starting TORL-4-500.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1

Monotherapy Dose Finding with TORL-4-500 administered intravenously once every 3 weeks

9 weeks
3 visits (in-person)

Treatment - Part 2

Expansion as Monotherapy with TORL-4-500 administered intravenously once every 3 weeks

9 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

  • TORL-4-500
Trial Overview The study tests TORL-4-500 to see how safe it is and how well it works against advanced cancers. It will also look at how the body processes the drug. This is an early-phase trial designed to gather initial data on this new potential treatment's effects on people with serious forms of cancer.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Monotherapy Dose Dose Finding - Part 1Experimental Treatment1 Intervention
TORL-4-500 iv once every 3 weeks
Group II: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention
TORL-4-500 iv once every 3 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

TORL Biotherapeutics, LLC

Lead Sponsor

Trials
6
Recruited
600+

Translational Research in Oncology

Collaborator

Trials
22
Recruited
6,700+

Findings from Research

APTO-253, a drug tested in a Phase I study with 32 patients suffering from advanced solid tumors, was found to be well tolerated, with fatigue being the most common side effect, occurring in over 10% of participants.
At the recommended Phase 2 dose of 229 mg/m², APTO-253 showed evidence of antitumor activity, achieving stable disease in 24% of patients, indicating potential effectiveness in treating advanced solid tumors.
Phase 1 study of APTO-253 HCl, an inducer of KLF4, in patients with advanced or metastatic solid tumors.Cercek, A., Wheler, J., Murray, PE., et al.[2021]
The study is investigating the safety and efficacy of combining toripalimab (an immune checkpoint inhibitor) with chemotherapy and radiotherapy in patients with unresectable stage IV esophageal squamous cell carcinoma, aiming to improve survival outcomes.
The trial will measure key outcomes such as progression-free survival and overall survival rates, with a focus on patient safety and quality of life, indicating a comprehensive approach to evaluating the treatment's effectiveness.
Toripalimab in Combination With Induction Chemotherapy and Subsequent Chemoradiation as First-Line Treatment in Patients With Advanced/Metastatic Esophageal Carcinoma: Protocol for a Single-Arm, Prospective, Open-Label, Phase II Clinical Trial (TR-EAT).Wu, L., Wang, Y., Li, B., et al.[2022]
The phase III JUPITER-6 trial demonstrated that toripalimab combined with chemotherapy significantly improves progression-free survival and overall survival in previously untreated patients with advanced esophageal squamous cell carcinoma.
These results highlight the importance of immune checkpoint inhibitors, like toripalimab, as essential components in the first-line treatment strategy for this type of cancer.
JUPITER-06 establishes immune checkpoint inhibitors as essential first-line drugs for the treatment of advanced esophageal squamous cell carcinoma.Yamamoto, S., Kato, K.[2022]

References

Phase 1 study of APTO-253 HCl, an inducer of KLF4, in patients with advanced or metastatic solid tumors. [2021]
Toripalimab in Combination With Induction Chemotherapy and Subsequent Chemoradiation as First-Line Treatment in Patients With Advanced/Metastatic Esophageal Carcinoma: Protocol for a Single-Arm, Prospective, Open-Label, Phase II Clinical Trial (TR-EAT). [2022]
JUPITER-06 establishes immune checkpoint inhibitors as essential first-line drugs for the treatment of advanced esophageal squamous cell carcinoma. [2022]
SALL4 is a marker of poor prognosis in serous ovarian carcinoma promoting invasion and metastasis. [2019]
Phase 1 trial of tivantinib in combination with sorafenib in adult patients with advanced solid tumors. [2021]
Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAFV600 mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis. [2022]
Critical Care Management of Toxicities Associated With Targeted Agents and Immunotherapies for Cancer. [2021]
Safety profile of drugs for advanced melanoma: A report based on 2008-2018 US Food and Drug Administration Data. [2021]
Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. [2023]
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Selective oestrogen receptor degraders in breast cancer: a review and perspectives. [2020]
Combined endocrine and targeted therapy in luminal breast cancer. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Practical Treatment Strategies and Future Directions After Progression While Receiving CDK4/6 Inhibition and Endocrine Therapy in Advanced HR+/HER2- Breast Cancer. [2021]
Management of hormone-receptor positive human epidermal receptor 2 negative advanced or metastatic breast cancers. [2020]
Metastatic breast cancer: Endocrine therapy landscape reshaped. [2020]
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