IN10018 Combination Therapy in Previously-treated Solid Tumors
Stopped: Sponsor decided for withdraw.
0Started 2025-08-13
Plain-language summary
This is a phase Ib/II, randomized, open-label, multicenter clinical trial to evaluate the antitumor activities, safety, tolerability and pharmacokinetics (PK) of IN10018 in combination with taxane and anti-PD-1/L1 monoclonal antibody in patients with locally advanced or metastatic solid tumors who have failed in or been intolerant to at least one line of standard therapy. This study will be firstly carried out in previously-treated non-small cell lung cancer (NSCLC) population,
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female aged 18-75 years old at the time of signing informed consent.
✓. Be able to understand and be willing to sign informed consent.
✓. Histologically or cytologically confirmed NSCLC, which is not suitable for locallly radical therapy.
✓. Subjects who have failed in 1- to 2 prior lines of standard systemic therapy.
✓. Has at least one measurable tumor lesion per RECIST 1.1.
✓. Has an ECOG performance status of 0 or 1.
✓. Estimated life expectancy is more than 3 months.
✓. Has adequate organ function.
Exclusion criteria
✕. Previously documented EGFR, ALK and ROS1 mutation.
✕. Have received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other antitumor drugs within 4 weeks prior to the first dose of study treatment.
✕. Have received other antitumor investigational drugs or treatments within 4 weeks prior to the first dose of study treatment.
✕. Have received radiotherapy within 14 days prior to the first dose of study treatment.
✕. Have had allogeneic haematopoietic stem cell transplantation or organ transplantation.
What they're measuring
1
Recommended phase II dose (RP2D) of IN10018 in combination with nab-paclitaxel and Tislelizumab
Timeframe: 3 years
2
Objective response rate (ORR) of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors per blinded independent central review (BICR) based on RECIST 1.1
✕. History of autoimmune disease within the past 2 years.
✕. Have an immunodeficiency disorder or have received systemic steroid therapy (prednisone or equivalent corticosteroid \> 10 mg/day) or other immunosuppressants within 7 days prior to the first dose of study treatment.