What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy and radiation therapy, often have a range of side effects. Chemotherapy can cause hematologic toxicities like neutropenia, anemia, and thrombocytopenia, as well as non-hematologic toxicities including nausea, vomiting, fatigue, and mucositis. Radiation therapy can lead to skin reactions, fatigue, and localized pain. Specific regimens, such as those involving cisplatin and etoposide, may also cause severe toxicities like anorexia and vomiting. The combination of these treatments can result in compounded side effects, necessitating careful management and monitoring.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors that focus on targeted therapies and kinase inhibitors. Examples include pembrolizumab, a PD-1 inhibitor used for various solid tumors, and bevacizumab, an anti-angiogenic agent used in combination with chemotherapy for multiple types of cancer. Additionally, drugs like sunitinib and erlotinib, which are tyrosine kinase inhibitors, have been approved for the treatment of renal cell carcinoma and non-small cell lung cancer, respectively. These treatments aim to inhibit specific pathways involved in tumor growth and proliferation, similar to the investigational approach of ON 123300.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include immune checkpoint inhibitors like pembrolizumab and nivolumab, targeted therapies such as atezolizumab combined with bevacizumab, and novel radioligand therapies like lutetium Lu 177 vipivotide tetraxetan. These therapies have shown efficacy in various solid tumors and are being actively studied in clinical trials.

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ON 123300 for Cancer

Phase 1

Recruiting

Research Sponsored by Traws Pharma, Inc.

Eligibility Criteria Checklist

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

Must have

≥ 18 years of age the time of signing the informed consent form (ICF)

Histological or cytological evidence of advanced and/or metastatic cancer,

Must not have

Patients with Grade ≥ 3 hypercalcemia (Corrected serum calcium > 12.5 mg/dL)

Who have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula, or

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ON 123300 to find the safest and most effective dose. It includes patients who pass initial health screenings. The drug is given frequently, with periodic blood tests and heart checks to monitor safety.

Who is the study for?

Adults with advanced/metastatic cancer, who've failed at least one treatment or lack options, can join. They must be able to take oral meds, have a life expectancy over 3 months, and use effective birth control. Excluded are those with certain blood disorders, recent treatments or surgeries, heart issues that could lead to Torsades de pointes (a type of heart rhythm problem), active infections like HIV/Hepatitis B/C, or expecting/nursing mothers.

What is being tested?

The trial is testing the safety of ON123300 at various doses to find the optimal dose for future studies. It's for patients whose cancers haven't responded well to other treatments and involves taking this new drug orally.

What are the potential side effects?

While specific side effects aren't listed here, common ones from drugs like ON123300 may include nausea, fatigue, risk of infection due to lowered immunity from chemotherapy-like agents; liver function changes; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer is advanced or has spread to other parts of my body.

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My cancer is advanced or has spread to other parts of my body.

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My liver function tests are within the required limits.

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I can do most activities without help.

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My blood, liver, and kidney functions are within the required ranges.

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I can swallow pills.

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I am 18 years old or older.

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I can swallow pills.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I can do most of my daily activities without help.

Exclusion Criteria

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

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My blood calcium level is higher than 12.5 mg/dL.

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My heart's electrical cycle is longer than normal.

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I am currently on medication that affects my heart's electrical cycle.

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I have a blood cancer diagnosis, but it's not non-Hodgkin's lymphoma.

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I have moderate to severe diarrhea before starting treatment.

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I do not have any severe illnesses that could interfere with the study.

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I had a blood clot in the past 6 months and am currently on treatment.

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I am allergic to medications similar to ON 123300.

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I do not have any active infections like HIV or Hepatitis B/C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Abnormal Laboratory Test results

Incidence of Dose Limiting Toxicities (DLT)

Incidence of adverse events (AE)

Secondary study objectives

Establish the recommended phase 2 dose (RP2D)

Pharmacokinetics of ON 123300 and 2 metabolites - AUClast

Pharmacokinetics of ON 123300 and 2 metabolites - CL/F

+4 more

Other study objectives

Preliminary efficacy of ON 123300

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ON 123300Experimental Treatment1 Intervention

ON 123300 capsules at increasing doses per cohort, starting at 40 mg

0 / 20Eligibility 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 solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These mechanisms are crucial for solid tumor patients as they offer different approaches to control tumor growth, improve survival rates, and potentially reduce side effects compared to traditional treatments. Investigational drugs like ON 123300 aim to optimize these effects by finding the safest and most effective doses, potentially offering new hope for better outcomes.

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