What is AL8326 studying for advanced solid tumors?

AL8326 is being studied in combination with Toripalimab to evaluate its preliminary safety and effectiveness in treating advanced recurrent or metastatic solid tumors. The trial aims to find the best dose for further study and assess how well the combination controls the cancer. This research is sponsored by Advenchen Laboratories, LLC.

Who may be eligible for this advanced solid tumors clinical trial?

Adults aged 18 years or older with advanced recurrent or metastatic solid tumors who have failed standard therapy or have no effective treatment options may be eligible. Both men and women can participate if they meet certain health and organ function criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumors clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07392736

Phase IIIa Study of AL8326 Tablets Combined With Toripalimab for Advanced Recurrent or Metastatic Solid Tumors

Led by Advenchen Laboratories, LLC · Updated on 2026-02-06

228

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the preliminary safety and effectiveness of AL8326 tablets combined with Toripalimab in patients who have advanced recurrent or metastatic solid tumors. This open, non-randomized phase IIIa trial aims to find the recommended phase II dose and assess objective remission rates among these patients who have limited treatment options or have experienced progression after standard therapies. The study has two parts Phase 1 involves sequential cohorts receiving AL8326 plus Toripalimab 240 mg in 28-day cycles, with dose escalation based on tolerance. Phase 2a continues treatment with AL8326 administered orally daily at the recommended dose alongside Toripalimab 240 mg given in 21-day cycles. Treatment cycles continue for up to 24 months or until disease progression or unacceptable toxicity. Participants will undergo regular assessments including tumor response evaluations every 2 to 4 cycles depending on the phase, along with safety monitoring and laboratory tests. Outcomes measured include remission rates, duration of remission, disease control, progression-free survival, and overall survival. The study requires participants to comply with follow-up procedures and safety evaluations throughout the treatment and observation periods.

CONDITIONS

Brief Title

A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Able to understand and voluntarily sign informed consent before any study procedures.
Age 18 years or older.
Histologically confirmed advanced recurrent or metastatic solid tumors with either failure of standard therapy, no effective treatment available, or treated with Toripalimab as second-line or later therapy.
At least one measurable lesion as defined by RECIST 1.1.
Completed prior cytotoxic chemotherapy at least 4 weeks before enrollment with recovery to grade 1 or less (except alopecia).
Life expectancy of at least 12 weeks at enrollment.
ECOG performance status 0 or 1.
Adequate organ function including bone marrow, renal, hepatic, and coagulation parameters.
Left ventricular ejection fraction above 50% at screening.
Systolic blood pressure under 140 mmHg and diastolic blood pressure under 90 mmHg, either untreated or controlled with a single medication.
For women of childbearing potential, negative pregnancy test within 7 days and agreement to use acceptable contraception during treatment and 3 months after last dose; must be non-lactating.
Postmenopausal or surgically sterilized women and men must agree to use contraception during treatment and 3 months after last dose.
Ability and willingness to comply with study protocol and follow-up procedures.

You will not qualify if you...

Received systemic cytotoxic or investigational therapy within 28 days or non-cytotoxic non-investigational therapy within 14 days before study treatment.
Major surgery requiring general anesthesia within 28 days or minor surgery within 7 days before study treatment.
Pregnant or lactating women.
History of second primary malignancy that may interfere with safety or efficacy assessments.
Active or untreated central nervous system metastases; stable brain metastases allowed if no progression for at least 4 weeks, treatment completed over 28 days ago, and no recent corticosteroid use.
Active, known, or suspected autoimmune disease or interstitial lung disease.
Need for systemic corticosteroids or immunosuppressive drugs within 14 days before study treatment.
Certain gastrointestinal conditions with risk of perforation or recent abdominal complications.
Untreated deep vein thrombosis within 6 months; treated DVT allowed if anticoagulated.
Uncontrolled infection.
Severe heart failure (NYHA Grade III or higher) or recent serious cardiac conditions.
Presence of unhealed wounds, fractures, ulcers, or symptomatic peripheral vascular disease.
Significant bleeding disorders or recent clinically significant bleeding.
QTcF interval 470 msec or higher on screening ECG.
Significant proteinuria detected in urine tests.
Positive tests for hepatitis B, hepatitis C, syphilis, or HIV with active viral load.
History of organ transplantation.
Conditions affecting drug intake or absorption.
Use of prohibited medications or recent blood transfusions.
Known severe allergies or intolerance to protein therapies.
Any severe or unstable medical, psychiatric, or other conditions that could affect safety or study compliance.

Research Team

Jianbo Wu

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Phase IIIa Study of AL8326 Tablets Combined With Toripalimab for Advanced Recurrent or Metastatic Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria