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

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdvenchen Laboratories, LLC

About this trial

This trial is an open, non-randomized, phase I/IIa clinical trial, which will evaluate the preliminary effectiveness and safety of AL8326 tablets in patients with advanced solid tumors

Eligibility criteria

Qualifiers

Subjects must be able to understand and voluntarily sign a written informed consent form prior to the initiation of any study-related procedures.

Age ≥ 18 years.

Failure of standard therapy (disease progression after treatment or intolerance to treatment toxicity);

no effective treatment available.

Disqualifiers

Received systemic cytotoxic therapy or investigational therapy within 28 days prior to initiation of study treatment, or non-cytotoxic, non-investigational therapy (e.g., radiotherapy, hormone therapy, targeted therapy, immunotherapy) within 14 days prior to initiation of study treatment.

Major surgery (defined as requiring general anesthesia within 28 days before initiation of study treatment, or minor surgery requiring general anesthesia within 7 days before initiation of study treatment).

Pregnant or lactating women.

History of prior or concurrent second primary malignancy that, in the opinion of the investigator or sponsor, may interfere with the assessment of safety or efficacy of the study treatment.

Trial design

Treatments tested in this trial

  • AL8326 tablets
  • Toripalimab

Treatment groups

228 Participants
are divided into 1 treatment group

Sponsors and collaborators