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

NCT07392736 | Recruiting Phase 1

• 1 other identifier: AL8326-CN-006
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• The first part (Phase I): Phase II recommended dose (RP2D)

  Determine the Recommended Phase 2 Dose (RP2D) via evaluation of dose limiting toxicity (DLT) events.

  At the end of Cycle 1 (each cycle is 28 days)

• The second part (Phase IIa):Objective remission rate (ORR)

  (ORR):The proportion of subjects achieving complete remission (CR) and partial remission (PR) with optimal efficacy according to RECIST 1.1.

  Every 2/3/4 cycles,up to 24 month（each cycle is 21 days）

Secondary Outcomes (11)

• The first part (Phase I): Objective remission rate (ORR)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• The first part (Phase I): Duration of remission (DOR)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• The first part (Phase I): Disease Control Rate (DCR)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• The first part (Phase I): Duration of Disease Control (DDC)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

• The first part (Phase I): Progression Free Survival (PFS)

  Every 2 cycles,up to 24 months (each cycle is 28 days)

Study Arms (1)

AL8326 plus toripalimab

EXPERIMENTAL

Phase 1: Cohort 1 will initiate with AL8326 +Toripalimab 240mg multiple dose (28-Day cycles) After three subjects have completed the first cycle of therapy without a DLT, additional cohorts may be enrolled sequentially. After the first cohort has completed one full cycle of therapy without a DLT, further cohorts will be enrolled sequentially, following the same 28-day cycle regimen. Phase 2a: Each subject will receive AL8326 +Toripalimab 240mg of this study for continuous 28-Day/21-Day cycles of therapy. AL8326 is orally administered daily at the RP2D found in Phase 1.

Drug: AL8326 tablets; Drug: Toripalimab

Interventions

AL8326 tablets DRUG

Tablet: 10mg/tablet; administered orally once daily

Also known as: AL8326

AL8326 plus toripalimab

Toripalimab DRUG

240mg Injection solution：21-Day cycles

AL8326 plus toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects with histologically confirmed advanced recurrent or metastatic solid tumors who meet one of the following conditions:
• Failure of standard therapy (disease progression after treatment or intolerance to treatment toxicity);
• no effective treatment available.
• Toripalimab monotherapy as a second-line or later standard treatment.
• Must have at least one measurable lesion as defined by RECIST 1.1.
• Prior cytotoxic chemotherapy must have been completed at least 4 weeks before enrollment, and any toxicities must have recovered to ≤ Grade 1 (except alopecia).
• Life expectancy of ≥ 12 weeks at the time of enrollment.
• ECOG performance status of 0 or 1.
• Adequate organ function:
• Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (1500/mm³); Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 9.0 g/dL.
• Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min.
• Hepatic function: Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for subjects with Gilbert's syndrome); AST and ALT ≤ 2.5 × ULN in subjects without liver metastases, or ≤ 5 × ULN in subjects with liver metastases.
• Coagulation function: International normalized ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

You may not qualify if:

• 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.
• Subjects with active or untreated central nervous system (CNS) metastases; Subjects with stable brain metastases may be enrolled if they meet the following criteria: a) No radiological evidence of progression for ≥ 4 weeks after completion of treatment; b) Completion of treatment ≥ 28 days before the first dose of study drug; c) No requirement for systemic corticosteroids (\>10 mg/day prednisone or equivalent) within ≤ 14 days prior to the first dose of study drug.
• Active, known, or suspected autoimmune disease or interstitial lung disease.
• Requirement for systemic therapy with corticosteroids or other immunosuppressive drugs within 14 days prior to initiation of study treatment.
• Peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with risk of perforation; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to initiation of study treatment.
• Untreated deep vein thrombosis (DVT) within the past 6 months. Subjects with DVT treated with therapeutic anticoagulants (excluding therapeutic warfarin) for at least 14 days prior to initiation of study treatment are allowed.
• Uncontrolled infection.
• New York Heart Association (NYHA) Grade III or greater congestive heart failure.
• History of any of the following cardiac conditions within 6 months prior to initiation of study treatment:
• Cardiac angioplasty or stenting;
• Myocardial infarction;
• Unstable angina;

Sponsors & Collaborators

• Advenchen Laboratories, LLC: lead

Study Sites (15)

National GCP Center for Anticancer Drugs,The Independent Ethics Committee

Beijing, Beijing Municipality, 100021, China

RECRUITING

The Cancer Hospital of the Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Hunan Cancer Hospital

Hunan, Changsha, 410000, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515000, China

RECRUITING

Yuebei People's Hospital

Shaoguan, Guangdong, 51200, China

RECRUITING

The First Affiliated Hospital of Guilin Medical Universty

Guilin, Guangxi, China

RECRUITING

Liuzhou Workers' Hospital

Liuchow, Guangxi, China

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530000, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

SIR RUN RUN SHAW Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Jing wang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• LingYIng Wu

  The Cancer Hospital of the Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianbo Wu

CONTACT

13951647454; williamwujianbo@advenchen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: February 6, 2026
• Study Start: October 26, 2021
• Primary Completion (Estimated): November 7, 2029
• Study Completion (Estimated): November 7, 2029
• Last Updated: February 6, 2026

Record last verified: 2025-09

Locations

CN (15)