Status:
NOT_YET_RECRUITING
IN10018 Combination Therapy in Previously-treated Solid Tumors
Lead Sponsor:
InxMed (Shanghai) Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the safety and recommended phase II dose (RP2D) of IN10018 in combination with taxane (nab-paclitaxel is proposed) and ant...
Eligibility Criteria
Inclusion
- 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.
- Note: Subjects should have received prior platinum-based doublet chemotherapy and anti-PD-1/L1-based systemic therapy and failed in treatment.
- 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.
- AEs due to prior antitumor therapy must be recovered to ≤ Grade 1 (CTCAE v5.0) or a steady state as assessed by investigators
- Subjects (male and female) with childbearing potential must agree to use contraception during the treatment phase and through 3 months after the last dose of study treatment.
Exclusion
- 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.
- 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.
- Currently have interstitial pneumonitis.
- Have had FAK inhibitors treatment.
- Have received prior nab-paclitaxel treatment and the first documented disease progression/recurrence is within 6 months since the last dose of nab-paclitaxel treatment.
- Malignancies other than the study disease within 3 years prior to the first dose of study treatment.
- Active central nervous system (CNS) metastases and/or carcinogenic meningitis.
- Has a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to the first dose.
- Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.
- Any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study. Note: Subjects who have experienced Grade ≥ 3 immuno-related AEs (irAEs) during prior immunotherapy will not be enrolled.
Key Trial Info
Start Date :
August 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05982522
Start Date
August 13 2025
End Date
December 31 2026
Last Update
April 30 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.