47 Participants Needed

Combination Therapy for Solid Tumors

Recruiting at 4 trial locations
RA
Overseen ByRobert Atkinson, PhD, MSCR
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Adlai Nortye Biopharma Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two new drugs, AN2025 and AN0025, alone and with an existing cancer drug, Atezolizumab, in patients with advanced or spreading tumors. The goal is to see if these new drugs can help fight cancer better, either by themselves or by enhancing the effects of Atezolizumab.

Who Is on the Research Team?

RA

Robert Atkinson, PhD, MSCR

Principal Investigator

Adlai Nortye US Inc

Are You a Good Fit for This Trial?

Adults (18+) with advanced solid tumors who have signed consent, can follow the trial protocol, and have a life expectancy of at least 3 months. They must have measurable disease, adequate heart function, and acceptable organ function levels. Women must not be pregnant or breastfeeding and agree to contraception; men also need to use contraception. Participants should have had prior systemic therapy unless no other survival-prolonging options exist but no more than four lines of treatment for advanced disease.

Inclusion Criteria

Life expectancy ≥3 months
My organs are functioning well.
Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan
See 8 more

Exclusion Criteria

Are currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment
I have severe nerve pain, lung or colon inflammation, high blood sugar, or uncontrolled thyroid issues from past treatments.
I have not had an infection needing treatment in the last 2 weeks.
See 33 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DLT Observation Period I

Patients are treated with AN2025 and Atezolizumab until disease progression, unacceptable toxicity, or withdrawal of consent

3 weeks
1 visit every 3 weeks

DLT Observation Period II

Patients are treated with AN0025 and Atezolizumab until disease progression, unacceptable toxicity, or withdrawal of consent

3 weeks
1 visit every 3 weeks

DLT Observation Period III

Patients are treated with AN2025, AN0025, and Atezolizumab until disease progression, unacceptable toxicity, or withdrawal of consent

3 weeks
1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • AN0025
  • AN2025
  • Atezolizumab
Trial Overview The study is testing AN2025 and AN0025 in combination with Atezolizumab against advanced/metastatic tumors. It's an early-phase trial assessing safety, how well the body handles these drugs (pharmacokinetics), tolerability, and initial effectiveness. Patients will receive either double or triple combinations of these treatments.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: DLT Observation Period III - AN2025, AN0025 and AtezolizumabExperimental Treatment3 Interventions
Group II: DLT Observation Period II - AN0025 and AtezolizumabExperimental Treatment2 Interventions
Group III: DLT Observation Period I - AN2025 and AtezolizumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adlai Nortye Biopharma Co., Ltd.

Lead Sponsor

Trials
8
Recruited
740+
Unbiased ResultsWe believe in providing patients with all the options.
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