WGI-0301 for Solid Tumors

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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug WGI-0301 for solid tumors?

The research on eftilagimod alpha (IMP321), a similar treatment, shows that it can activate immune cells and improve outcomes when combined with chemotherapy in breast cancer patients. This suggests that treatments like WGI-0301, which may have similar mechanisms, could potentially be effective for solid tumors. ^{1 2 3 4 5}

What safety information is available for WGI-0301 (immune checkpoint inhibitors) in humans?

Immune checkpoint inhibitors, like WGI-0301, can cause side effects such as colitis (inflammation of the colon), hepatobiliary disorders (liver and bile duct issues), and pancreatitis (inflammation of the pancreas). These side effects are more common when used with other cancer treatments and can sometimes lead to stopping the treatment. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

["Three steps procedure" in the treatment of large pancreatic head cancer]. [2013]

2. England pubmed.ncbi.nlm.nih.gov

AIPAC: a Phase IIb study of eftilagimod alpha (IMP321 or LAG-3Ig) added to weekly paclitaxel in patients with metastatic breast cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Combination of oxaliplatin plus irinotecan in patients with gastrointestinal tumors: results of two independent phase I studies with pharmacokinetics. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A phase I study of IMP321 and gemcitabine as the front-line therapy in patients with advanced pancreatic adenocarcinoma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical outcomes of patients with gastric carcinoma: the importance of primary tumor location and microvessel invasion. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitor gastritis is often associated with concomitant enterocolitis, which impacts the clinical course. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse events of immune checkpoint inhibitors for patients with digestive system cancers: A systematic review and meta-analysis. [2022]

9. Switzerland 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. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The risk of diarrhea and colitis in patients with lung cancer treated with immune checkpoint inhibitors: a systematic review and meta-analysis. [2023]