Evaluating WGI-0301 for patients with advanced solid tumors

A Phase I, First in Human, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301, a Lipid Nanoparticle Suspension of Akt-1 Antisense Oligonucleotide, in Patients With Advanced Solid Tumors

This study is testing a new drug called WGI-0301 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang Haichang Biotech Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Los Angeles, California and 2 other locations)
• Trial ID: NCT05267899 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and pharmacokinetics of a new drug called WGI-0301 in patients with advanced solid tumors. It will determine the optimal dosage for treating these tumors and how the drug is absorbed and affects the body. Participants will be closely monitored to evaluate their response to the treatment and any side effects experienced during the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced, histologically confirmed solid tumors that have progressed after standard therapy.

Not a fit: Patients with early-stage tumors or those who are candidates for curative therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted other therapies.

How similar studies have performed: Other studies evaluating similar pharmacological approaches have shown promise, but this specific drug is being tested for the first time in humans.

Eligibility criteria

Inclusion Criteria Subjects must meet all the following criteria to participate this study

1. Subject with measurable disease based on RECIST 1.1.
2. 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.
3. Pathologically confirmed solid tumors.
4. Patients with advanced solid tumors (unresectable or metastatic) who failed standard therapy (disease progression or intolerance).
5. Capable of understanding the written informed consent, provides signed, dated, and witnessed written informed consent, and agrees to comply with the study protocol.
6. Age 18 years or older at first screening/ examination visit.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, measured within 72 hours of 1st treatment.
8. Adequate hematological function \[absolute neutrophil count (ANC) ≥ 1.5 × 109/L\], \[Platelets ≥ 100 × 109/L\], \[Hemoglobin ≥ 9 g/dL\], and \[Serum albumin ≥ 2.8 g/dL\].
9. Adequate renal function \[calculated estimate glomerular filtration rate (eGFR) of ≥ 50mL/min\] using the CKD-EPI Creatinine Equation (2021).
10. Adequate hepatic function \[total bilirubin ≤ 1.5 x UNL; AST (aspartate transaminase) or ALT (alanine transaminase) ≤ 3 x UNL or ≤ 5 x UNL if due to liver involvement by tumor.
11. Negative pregnancy test for women of child-bearing potential (WOCBP) and males need to agree to use a highly effective method of contraception if not surgically sterile prior to study entry, while on drug, and for 3 months' time after the last dose. Please refer to Appendix 1 for acceptable effective contraceptive methods.
12. Subject who has predicted life expectancy of at least 12 weeks.

Exclusion Criteria Subjects meet one or more of below criteria will be excluded

1. Lactating, pregnant, or intend to be pregnant.
2. Received anti-cancer therapy or other investigational drugs within 4 weeks prior to the 1st dose of study drug.
3. Patient in use of sensitive substrates of major cytochrome P450 enzymes and transporters based on FDA Drug Development and Drug Interactions, Table of Substrates, Inhibitors, and Inducers, or strong inducers of transporter, P-gp, including apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort. Patient in use of strong inhibitors of transporters based on based on FDA Drug Development and Drug Interactions, Table of Substrates, Inhibitors, and Inducers (Appendix 2).
4. All acute toxic effect of any prior antitumor therapy resolved to Grade 1 before the start of study therapy (with the exception of alopecia \[G 1 or 2 permitted\], neurotoxicity \[Grade ≤ 2 permitted\], or selected lab parameters \[Grade \< 2 permitted with exceptions noted below\].
5. Has evidence of another malignancy not in remission or history of such a malignancy within the last 3 years (except for treated basal or squamous cell carcinoma of the skin, or in situ cancer of the cervix). Concomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma; low grade prostate cancer treated with prostatectomy more than 5 years ago; early-stage melanoma treated with complete surgical excision more than 5 years ago; carcinoma in situ of cervix treated with cone procedure more than 8 years ago.
6. Has symptomatic central nervous system (CNS) metastases, except where metastases are stable over a three-month period.
7. Has unstable bleeding disorder or currently under non-established course of anticoagulant therapy (except for the use of heparinized saline to maintain the patency of central venous catheters).
8. Has a medical history of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
9. Has a medical history of myocardial infarction or unstable angina within 6 months before registration.
10. Has a QTcF prolongation to \> 470 ms based on a 12-lead ECG in triplicate, or other abnormalities that in the opinion of the Investigator increase the risk of participating in the study.
11. 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.
12. Has evidence of electrolyte imbalance such as hypokalemia, hypocalcemia, and hypomagnesaemia of NCI-CTCAE Grade ≥ 2 (symptomatic, intervention indicated).
13. Major surgery besides tumor resection, within 4 weeks prior to screening
14. Has uncontrolled diabetes mellitus, neurologic or psychiatric condition, an ongoing systemic (including opportunistic) clinically significant infections or any other significant or unstable concurrent medical illness that may increase the risk of study participants determined by Investigator.
15. Has a known history of human immunodeficiency virus

Where this trial is running

Los Angeles, California and 2 other locations

• Valkyrie Clinical Trials — Los Angeles, California, United States (Recruiting)
• The Oncology Institute of Hope and Innovation — Whittier, California, United States (Recruiting)
• University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Chao Wang, Pharm. D, BCPS, CCRP

Conditions Advanced Solid Tumors