IN10018 Combination Therapy in Previously-treated Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-13

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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,

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

NCT07174908

Non-Small Cell Lung Cancer

RECRUITING PHASE3

A Study of TXN10128 in Subjects With Solid Tumors

NCT05978492

Locally Advanced (Unresectable) or Metastatic Solid Tumors

RECRUITING PHASE1

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

NCT06536868

Extensive-stage Small-cell Lung Cancer

RECRUITING PHASE2

Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy

NCT06490068

Advanced Solid Tumor

RECRUITING PHASE2

Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors

NCT05145907

Triple-negative Breast Cancer Head and Neck Squamous Cell Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed) in previously-treated solid tumors. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy and safety of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors. This study will be firstly carried out in previously-treated NSCLC population, and after getting enough efficacy and safety data of IN10018+nab-paclitaxel+Tislelizumab in NSCLC population and also taken into consideration of disease background of other specific solid tumors, sponsor will decide if to expand the treatment regimen into other solid tumors.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

IN10018 + nab-paclitaxel + Tislelizumab in previously-treated NSCLC

Group Type EXPERIMENTAL

IN10018

Intervention Type DRUG

orally taken once daily

Nab-paclitaxel

Intervention Type DRUG

125 mg/m2 D1, 8 Q3W, Intravenously

Tislelizumab

Intervention Type DRUG

200mg Q3W, Intravenously

Control Group

Nab-paclitaxel + Tislelizumab in previously-treated NSCLC

Group Type ACTIVE_COMPARATOR

Nab-paclitaxel

Intervention Type DRUG

125 mg/m2 D1, 8 Q3W, Intravenously

Tislelizumab

Intervention Type DRUG

200mg Q3W, Intravenously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IN10018

orally taken once daily

Intervention Type DRUG

Nab-paclitaxel

125 mg/m2 D1, 8 Q3W, Intravenously

Intervention Type DRUG

Tislelizumab

200mg Q3W, Intravenously

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BI 853520

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female aged 18-75 years old at the time of signing informed consent.
2. Be able to understand and be willing to sign informed consent.
3. 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.
4. Subjects who have failed in 1- to 2 prior lines of standard systemic therapy.
5. Has at least one measurable tumor lesion per RECIST 1.1.
6. Has an ECOG performance status of 0 or 1.
7. Estimated life expectancy is more than 3 months.
8. Has adequate organ function.
9. AEs due to prior antitumor therapy must be recovered to ≤ Grade 1 (CTCAE v5.0) or a steady state as assessed by investigators
10. 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 Criteria

1. Previously documented EGFR, ALK and ROS1 mutation.
2. Have received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other antitumor drugs within 4 weeks prior to the first dose of study treatment.
3. Have received other antitumor investigational drugs or treatments within 4 weeks prior to the first dose of study treatment.
4. Have received radiotherapy within 14 days prior to the first dose of study treatment.
5. Have had allogeneic haematopoietic stem cell transplantation or organ transplantation.
6. History of autoimmune disease within the past 2 years.
7. 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.
8. Currently have interstitial pneumonitis.
9. Have had FAK inhibitors treatment.
10. 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.
11. Malignancies other than the study disease within 3 years prior to the first dose of study treatment.
12. Active central nervous system (CNS) metastases and/or carcinogenic meningitis.
13. Has a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to the first dose.
14. Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.
15. Any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
16. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No