WGI-0301 for Solid Tumors

Not currently recruiting at 3 trial locations

Overseen By Chao Wang, Pharm. D, BCPS, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Zhejiang Haichang Biotech Co., Ltd.

Must not be taking: Anticonvulsants, St. John's wort

Disqualifiers: Pregnancy, CNS metastases, CHF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, WGI-0301, to determine the optimal dose and assess its safety for individuals with solid tumors unresponsive to other treatments. Researchers aim to understand how the body absorbs the drug and its effects. The trial seeks participants with advanced solid tumors that continue to grow despite treatment. Those with tumors that cannot be removed or have spread, and who have tried other unsuccessful treatments, may find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically those that are sensitive substrates of major cytochrome P450 enzymes and transporters, or strong inducers or inhibitors of these transporters. If you are taking any of these medications, you will need to stop them before participating in the trial.

Is there any evidence suggesting that WGI-0301 is likely to be safe for humans?

Research has shown that WGI-0301, a new treatment for solid tumors, is being tested for safety and efficacy. In earlier studies, patients with advanced solid tumors received WGI-0301 to assess their tolerance. These studies aim to determine the optimal dose that patients can take without experiencing serious side effects.

As an early-stage study, the primary goal is to evaluate the safety and tolerability of WGI-0301. The research is ongoing, with scientists still gathering data on how the body processes the drug and its effects. This early testing is crucial to ensure safety before progressing to larger studies. If WGI-0301 shows promise, it may advance to later phases to further confirm its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

WGI-0301 is unique because it represents a novel approach to treating solid tumors. Unlike standard treatments like chemotherapy and radiation, which often target both healthy and cancerous cells, WGI-0301 is designed to specifically target tumor cells, potentially reducing damage to healthy tissue. Researchers are particularly excited about WGI-0301 because of its targeted mechanism, which might offer a more focused attack on cancer cells, leading to fewer side effects and potentially improving patient outcomes. This precision in targeting tumor cells is what sets WGI-0301 apart from existing options and fuels optimism in the field.

What evidence suggests that WGI-0301 might be an effective treatment for solid tumors?

Research has shown that WGI-0301, the investigational treatment in this trial, may help treat solid tumors. In studies, WGI-0301 slowed tumor growth by 46.16%, a significant reduction. Participants treated with it lived an average of 55 days longer, suggesting it might extend life. Researchers are also examining the treatment's safety and how the body processes it. Although still in early stages, these results suggest that WGI-0301 could be a promising option for people with solid tumors. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Capable of understanding the written informed consent, provides signed, dated, and witnessed written informed consent, and agrees to comply with the study protocol

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

My advanced cancer did not respond to standard treatments.

Exclusion Criteria

I am currently taking medication that strongly affects drug metabolism.

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

I have not had any cancer except for specific skin, prostate, melanoma, or cervical cancers treated over 5 years ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive WGI-0301 to evaluate safety, tolerability, and pharmacokinetics

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WGI-0301

Trial Overview 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).

How Is the Trial Designed?

Group I: WGI-0301 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Zhejiang Haichang Biotech Co., Ltd.

Lead Sponsor

Trials

2

Recruited

80+

Published Research Related to This Trial

A study analyzing 70,330 adverse events reported to the FDA found that immune checkpoint inhibitors (ICIs) significantly increase the risk of gastrointestinal (GI) toxicities, particularly colitis, hepatobiliary disorders, and pancreatitis, with colitis showing the highest reporting odds ratio of 17.2.

The risk of these GI adverse events was notably higher with anti-CTLA-4 treatments compared to anti-PD-1 and anti-PD-L1 therapies, and factors such as female gender and polytherapy were identified as strong risk factors for these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Immune-Related Adverse Events of Immune Checkpoint Inhibitors in the Gastrointestinal System: A Study Based on the US Food and Drug Administration Adverse Event Reporting System. Bai, X., Jiang, S., Zhou, Y., et al.[2021]

Immune checkpoint antibodies targeting the PD-1/PD-L1 pathway have shown significant antitumor activity and have been approved for use as single-agent therapies in metastatic malignant melanoma and nonsmall-cell lung cancer.

Understanding the toxicities associated with PD-1/PD-L1 blockade and having effective management strategies is crucial for maximizing both the safety and efficacy of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Naidoo, J., Page, DB., Li, BT., et al.[2023]

In a meta-analysis of 21 studies involving 7108 patients, immune checkpoint inhibitors (ICIs) for digestive system cancers showed a high incidence of treatment-related adverse events (trAEs) at 82.7%, with 27.5% experiencing severe (grade 3 or higher) events.

The analysis revealed that the incidence and characteristics of adverse events varied significantly based on cancer type, treatment modality, and specific ICI agents, highlighting the need for tailored monitoring and intervention strategies to manage these side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of immune checkpoint inhibitors for patients with digestive system cancers: A systematic review and meta-analysis. Kou, L., Wen, Q., Xie, X., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05267899

Study Details | NCT05267899 | A Phase I First in Human ... The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and ...

2. withpower.com withpower.com/trial/phase-1-neoplasms-3-2022-3e992

WGI-0301 for Solid Tumors 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 ...

3. aacrjournals.org aacrjournals.org/cancerres/article/83/7_Supplement/5123/724158/Abstract-5123-The-anti-tumor-and-anti-angiogenic

Abstract 5123: The anti-tumor and anti-angiogenic effects of a ... The tumor growth inhibition % (TGI) for WGI-0301 was 46.16%, and the medium survival time (MST) of the treatment group was 55 days, which was ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1525001625001728

Clinical applications of oligonucleotides for cancer therapy This review provides a comprehensive overview of ONTs in clinical trials, emerging delivery strategies, and innovative therapeutic approaches.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10011800/

Research progress on non-protein-targeted drugs for cancer ... Clinical trial results showed that Atu027 serves a new treatment strategy for solid tumors and has good safety and activity profile in patients ...

6. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/akt-1-antisense-oligonucleotide-wgi-0301

Clinical Trials Using Akt-1 Antisense Oligonucleotide WGI- ... A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors. Status: Active.

7. delta.larvol.com delta.larvol.com/Products/?ProductId=921a2b13-8141-43d7-a4fa-04eebcb58a57

Mychexin (WGI-0301) / Opus Genetics, Zhejiang Haichang ... A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors (clinicaltrials ...

8. careacross.com careacross.com/clinical-trials/trial/NCT06309485

Phase 2 Study of WGI-0301 for Advanced HCC Summary: The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its ...