Phase 2 Lung Cancer Trial, Recruiting NCT06632262 Sponsor: Abbisko Therapeutics Co, Ltd Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06632262
Recruiting Phase 2

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 a solid tumor (cancer) that can be measured on a scan, and your cancer has gotten worse after standard treatments, you could not tolerate standard treatments, or no standard treatment exists for your cancer type (this applies to the early dose-finding phase of the trial)
  • Your tumor has been tested and shown to have specific changes in the FGFR2 or FGFR3 gene (such as mutations, fusions, rearrangements, or amplifications) or unusually high levels of these proteins, confirmed by a lab test or previous test report
  • Stomach/food pipe junction cancer group: You have been confirmed to have advanced or inoperable stomach or gastroesophageal junction cancer that tested negative for HER2, with FGFR2 amplification or overexpression confirmed by testing, and you have had little or no prior systemic treatment for advanced disease (or your cancer came back more than 6 months after finishing adjuvant therapy)
  • Bladder/urinary tract cancer group: You have been confirmed to have advanced or inoperable urothelial (urinary tract) cancer with specific FGFR2/3 gene changes confirmed by testing, and you meet certain treatment history requirements (confirm with trial site)
  • Non-small cell lung cancer group: You have been confirmed to have advanced or inoperable non-small cell lung cancer with specific FGFR2/3 gene changes confirmed by testing, and your cancer has gotten worse or you could not tolerate at least one prior standard treatment
  • Other solid tumors group: You have been confirmed to have another type of advanced or inoperable solid tumor with specific FGFR2/3 gene changes confirmed by testing, and your cancer has gotten worse or you could not tolerate at least one prior standard treatment
  • You are able to provide a previous tumor tissue sample or are willing to have a biopsy if needed (for the stomach/food pipe junction cancer group)

Who may not be able to join:

  • You have previously been treated with a drug that specifically blocks the FGFR pathway
  • You have an active autoimmune disease (a condition where your immune system attacks your own body), such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions — though some milder conditions such as controlled thyroid disease, type 1 diabetes, or certain skin conditions may be allowed (confirm with trial site)
  • You have had significant lung disease symptoms — such as lung scarring or severe radiation-related lung damage — that required steroid treatment within the past 6 months
  • You have another active cancer that is progressing or needs treatment, with some exceptions such as certain cured skin cancers or early-stage prostate cancer (confirm with trial site)
  • You have not had enough time since your last cancer treatment before starting this trial — for example, major surgery or certain types of radiotherapy within the last 4 weeks, or recent chemotherapy, immunotherapy, or targeted therapy (exact timeframes depend on the treatment type — confirm with trial site)
  • You still have significant side effects (worse than mild) from previous cancer treatments that have not fully resolved, with some exceptions such as hair loss or mild nerve-related symptoms
  • You previously had a severe (grade 3 or higher) immune-related side effect from a prior cancer treatment
  • If you are in the lung cancer group and your cancer has a known treatable gene change (such as EGFR, ALK, KRAS, or others) but you have never received the targeted therapy for it, you may not be eligible (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 30 June 2026
Phase 2: approximately ~30% 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.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Abbisko Therapeutics Co, Ltd
Registry
ClinicalTrials.gov
Start date
13 November 2024
Est. completion
30 November 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of Dose limited toxicity (DLT); To assess the tolerability of ABSK061 + ABSK043 in combination with CAPOX in patients with first-line gastric/gastroesophageal junction cancer; To assess the anti-tumor activity of ABSK061 + ABSK043 in combination with CAPOX as the primary endpoint of Progression-free survival (PFS) in first-line treatment of patients with metastatic/unresectable HER2-gastric/gastroesophageal junction cancer; To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable urothelial cancer with FGFR2/3 activating alteration or FGFR3 over...

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: 30 June 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