Phase 1 Mesothelioma Trial, Recruiting NCT03917043 Sponsor: Ascentage Pharma Group Inc. Condition: Mesothelioma
Back to Mesothelioma

Phase 1 Mesothelioma Trial, Recruiting

NCT03917043
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with non-small cell lung cancer (NSCLC) with a specific gene change (ALK or ROS1 fusion), malignant pleural mesothelioma, esophageal cancer, or ovarian cancer at an advanced stage (for the initial phase of the trial).
  • For the expansion phase: either you have NSCLC with an ALK/ROS1 gene change and have already tried targeted therapy (TKI) but it stopped working or you could not tolerate it, with a specific protein marker (pFAK) score of 10 or above — OR you have NSCLC with an ALK/ROS1 gene change and have never had targeted therapy before.
  • You are generally well enough to carry out light activity and care for yourself (rated 0 or 1 on a standard fitness scale used by doctors).
  • Your life expectancy is at least 3 months.
  • You have at least one tumour that can be measured on a scan.
  • Your blood counts and bone marrow are working well enough (confirm with trial site).
  • Your kidneys and liver are functioning well enough (confirm with trial site).
  • Your heart is functioning normally.
  • If you have cancer that has spread to the brain, your symptoms are currently stable and under control.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before taking the first dose.
  • You and your partner are willing to use effective contraception during the trial and for at least 30 days after the last dose.
  • You are able to understand the trial information and are willing to sign a consent form.
  • You are willing and able to attend all required visits and follow-up appointments.
  • You can provide a tumour tissue sample (either a recent or previously stored sample) taken within 28 days before treatment starts; if no sample is available, this may be discussed with the trial team.
  • You are willing to provide a fresh tumour tissue sample taken before treatment begins.

Who may not be able to join:

  • You are currently receiving other cancer treatments such as chemotherapy, radiotherapy, immunotherapy, or biological therapy, or have taken part in another experimental drug trial within the past 28 days.
  • You have taken targeted therapy (TKI) within the 8 days before starting the trial drug.
  • You still have significant side effects from a previous cancer treatment that have not resolved.
  • You have difficulty swallowing, problems absorbing medicines, or another condition that could prevent you from taking the trial drug properly.
  • You have a significant history of heart or cardiovascular disease.
  • You have not fully recovered from a recent operation, or you have had major surgery within the past 28 days or minor surgery within the past 14 days.
  • You have an active, serious infection, including HIV or active hepatitis B or C.
  • You have a known allergy to any ingredient in the trial drug or similar medicines.
  • You are pregnant, breastfeeding, or planning to become pregnant during the trial.
  • You have any other condition that, in the opinion of the doctor, could put your safety at risk or affect the trial results.
  • You have taken certain medications that affect how the body processes drugs (specifically moderate inhibitors or inducers of CYP3A4, CYP2C9, or CYP2C19) within the week before starting the trial (confirm with trial site).
  • You have taken certain other medications with a very narrow safe dosing range that are broken down by a specific liver enzyme (CYP3A4 substrates with a narrow therapeutic window) within the week before starting the trial (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Li Zhang, Professor, Sun Yat-Sen University Cancer Center

Phone: +86-20-28069260

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Ascentage Pharma Group Inc.
Registry
ClinicalTrials.gov
Start date
27 May 2019
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Maximum Tolerated Dose (MTD); Recommended Phase 2 dose (RP2D)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov