What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy often causes nausea, vomiting, diarrhea, fatigue, hair loss, and neuropathy. Targeted therapies can lead to diarrhea, liver issues, skin rashes, and high blood pressure. Immunotherapy may result in immune-related side effects such as pneumonitis, colitis, hepatitis, and endocrine disorders. The investigational drug WGI-0301, being studied for solid tumors, may have similar side effects, though its specific profile is not yet fully established.

What prior FDA approvals exist?

FDA-approved treatments for solid tumors have included a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. Examples include paclitaxel, cisplatin, and etoposide, which are often used in combination with radiation therapy for cancers like small-cell lung cancer. Targeted therapies such as pembrolizumab and bevacizumab have also been approved for various solid tumors, focusing on specific molecular targets and pathways. These treatments aim to inhibit tumor growth and spread by interfering with specific cellular mechanisms, similar to the investigational approach of WGI-0301, which is being studied for its safety, tolerability, and pharmacokinetic properties in patients with advanced solid tumors.

What other types of research exist?

Promising novel alternatives to WGI-0301 for solid tumor patients include: 1) The combination of BRAF^V600E inhibitor (PLX4720) and tyrosine kinase inhibitor (Ponatinib), which has shown significant synergistic anticancer activity in preclinical models of BRAF^V600E thyroid cancer. 2) Pembrolizumab, which has been evaluated in combination with chemotherapy for non-small cell lung cancer and other solid tumors, showing improved survival rates. 3) Infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, which has shown efficacy in patients with advanced cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements.

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WGI-0301 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Zhejiang Haichang Biotech Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Advanced, histologically or cytologically confirmed solid tumors who have progressed from current therapy or who have relapsed after prior therapy and are not candidates for potentially curative therapy

Patients with advanced solid tumors (unresectable or metastatic) who failed standard therapy (disease progression or intolerance)

Must not have

Has higher or equal to Grade 3 hypertension (≥ 160/100 mmHg) or ≤ 80/50 mmHg; has heart rate (HR) ≥ 100 beats per minute (bpm), or ≤ 45 bpm, confirmed by a repeat assessment

Major surgery besides tumor resection, within 4 weeks prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 16 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called WGI-0301 to find the best dose for treating solid tumors. It aims to see how safe and tolerable the medicine is for patients with these tumors. Researchers will also study how the body absorbs and reacts to the medicine.

Who is the study for?

Adults (18+) with advanced solid tumors that have worsened after treatment or are untreatable, who can understand and consent to the study. They must be in fairly good health overall, not pregnant, willing to use contraception, and expected to live at least 12 weeks. People with certain other medical conditions or treatments are excluded.

What is being tested?

The trial is testing WGI-0301's safety and optimal dosing for treating solid tumors. It involves studying how the body absorbs it (pharmacokinetics) and its effects on the body (pharmacodynamics).

What are the potential side effects?

Specific side effects of WGI-0301 aren't listed but generally may include reactions at the infusion site, fatigue, nausea, blood count changes, organ inflammation or dysfunction due to drug toxicity.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned or worsened after treatment and cannot be cured with surgery or other therapies.

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My advanced cancer did not respond to standard treatments.

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My blood tests show normal white blood cells, platelets, hemoglobin, and albumin levels.

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I am 18 years old or older.

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My kidney function is good, with an eGFR of 50 mL/min or higher.

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My cancer is a solid tumor confirmed by a biopsy.

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My liver functions within normal limits, or slightly above if due to my cancer.

Exclusion Criteria

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

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My blood pressure is very high or very low, and my heart rate is too fast or too slow.

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I have not had major surgery other than tumor removal in the last 4 weeks.

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I have a significant electrolyte imbalance like low potassium, calcium, or magnesium.

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I do not have an unstable bleeding disorder and am not on new blood thinners.

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I have heart failure or serious heart rhythm problems that need treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 16 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

Recommended Phase 2 Dose of WGI-0301

Safety and tolerability

Secondary study objectives

Area under the curve

Half-life

Maximum plasma concentration

+1 more

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: WGI-0301Experimental Treatment1 Intervention

0 / 12Eligibility 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

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as those inhibiting specific proteins or pathways involved in tumor growth (e.g., HER2 or VEGF inhibitors), aim to block the growth and spread of cancer cells more precisely, potentially reducing side effects. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. The investigational drug WGI-0301, being studied for its effects on solid tumors, likely involves mechanisms that target specific pathways or enhance immune response, aiming to improve treatment efficacy and patient outcomes. Understanding these mechanisms is crucial for developing more effective and tolerable treatments for solid tumor patients.

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