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Solid TumorPhase 1/2NCT05982522

IN10018 Combination Therapy in Previously-treated Solid Tumors

A Phase 1/2 study testing IN10018, Nab-paclitaxel and Tislelizumab in people with Solid Tumor, run by InxMed (Shanghai) Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
IN10018, Nab-paclitaxel and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
13 Aug 2025to 31 Dec 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

Official title: A Multicenter, Open-Label, Randomized, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Taxane and Anti-PD-1/L1 Monoclonal Antibody in Previously-treated Solid Tumors

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,

Read the 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 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
Solid Tumor
Being tested
IN10018, Nab-paclitaxel, Tislelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IN10018Drug

    Also called BI 853520

    orally taken once daily

  • Nab-paclitaxelDrug

    125 mg/m2 D1, 8 Q3W, Intravenously

  • TislelizumabDrug

    200mg Q3W, Intravenously

Study groups in NCT05982522
Study groupRoleWhat they receive
Experimental GroupExperimentalIN10018 + nab-paclitaxel + Tislelizumab in previously-treated NSCLC
Receives: Drug: IN10018; Drug: Nab-paclitaxel; Drug: Tislelizumab
Control GroupActive comparatorNab-paclitaxel + Tislelizumab in previously-treated NSCLC
Receives: Drug: Nab-paclitaxel; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

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

    Measured: 3 years

Secondary outcomes (13)

  1. 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

    Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.

    Measured: 3 years

  2. 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

    Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.

    Measured: 3 years

  3. 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.

    Defined as the proportion of patients with CR, PR, or stable disease (SD).

    Measured: 3 years

  4. 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.

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

    Measured: 3 years

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

    Defined as the time from randomization to the date of death due to any cause.

    Measured: 3 years

  6. Number of patients with adverse event

    The number of participants who experienced AEs is presented.

    Measured: 3 years

  7. PK: AUC of IN10018 following single dose administration and at steady state

    Area under the concentration-time curve (AUC)

    Measured: 3 years

  8. PK: Cmax of IN10018 following single dose administration and at steady state

    Maximum concentration (Cmax)

    Measured: 3 years

  9. PK:Ctrough of IN10018 following single dose administration and at steady state

    Trough concentration (Ctrough)

    Measured: 3 years

  10. PK:Tmax of IN10018 following single dose administration and at steady state

    Time to Cmax (Tmax)

    Measured: 3 years

  11. PK:t1/2 of IN10018 following single dose administration and at steady state

    Elimination half-life (t1/2).

    Measured: 3 years

  12. PK:CL/F of IN10018 following single dose administration and at steady state

    apparent clearance (CL/F)

    Measured: 3 years

  13. PK:Vd/F of IN10018 following single dose administration and at steady state

    Apparent volume of distribution (Vd/F)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start13 Aug 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: Sponsor decided for withdraw.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982522
Sponsor's protocol ID
IN10018-017
Status last verified
Apr 2025
First submitted
13 Jul 2023
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IN10018, Nab-paclitaxel and Tislelizumab in people with Solid Tumor, run by InxMed (Shanghai) Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose (RP2D) of IN10018 in combination with nab-paclitaxel and Tislelizumab (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05982522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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