IN10018 Combination Therapy in Previously-treated Solid Tumors

NCT05982522 | Withdrawn Phase 1 DMC

• 1 other identifier: IN10018-017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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,

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Recommended phase II dose (RP2D) of IN10018 in combination with nab-paclitaxel and Tislelizumab

  Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with nab-paclitaxel and Tislelizumab.

  3 years

• 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

  Defined as the proportion of subjects with complete response (CR) or partial response (PR)

  3 years

Secondary Outcomes (13)

• Progression-free survival (PFS) of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors per BICR and investigators based on RECIST 1.1

  3 years

• Duration of objective response (DOR) of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors per BICR and investigators based on RECIST 1.1

  3 years

• Disease Control Rate (DCR) of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors per BICR and investigators based on RECIST 1.1.

  3 years

• Objective response rate (ORR) of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors per investigators based on RECIST 1.1.

  3 years

• Overall survival (OS) in IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors.

  3 years

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Drug: IN10018; Drug: Nab-paclitaxel; Drug: Tislelizumab

Control Group

ACTIVE COMPARATOR

Nab-paclitaxel + Tislelizumab in previously-treated NSCLC

Drug: Nab-paclitaxel; Drug: Tislelizumab

Interventions

IN10018 DRUG

orally taken once daily

Also known as: BI 853520

Experimental Group

Nab-paclitaxel DRUG

125 mg/m2 D1, 8 Q3W, Intravenously

Control Group; Experimental Group

Tislelizumab DRUG

200mg Q3W, Intravenously

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; tislelizumab

Study Officials

• Jifeng Feng

  Jiangsu Province Cancer Hosipital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 8, 2023
• Study Start: August 13, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-04