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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • AL8326 tablets

    Drug

    Tablet: 10mg/tablet; administered orally once daily

  • Toripalimab

    Drug

    240mg Injection solution：21-Day cycles

Treatment groups

228 Participants
are divided into 1 treatment group
Group A: AL8326 plus toripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

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.

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

Secondary outcomes

1

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

(ORR):The proportion of subjects achieving complete remission (CR) and partial remission (PR) .

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

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

(DOR):Description: The time between the start of the first assessment of the tumor as CR or PR and The first assessment of disease progression (PD) or death from any cause.

Time frame
Every 2 cycles,up to 24 months (each cycle is 28 days)
3

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

(DCR): The proportion of subjects achieving complete remission (CR), partial remission (PR) and stable disease (SD).

Time frame
Every 2 cycles,up to 24 months (each cycle is 28 days)
4

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

(DDC): The time from the first assessment of the tumor as CR, PR, or SD to the first assessment of disease progression (PD) or death from any cause.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Advenchen Laboratories, LLC

Lead sponsor

Source ClinicalTrials.gov
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