CClinicalTrials.gg
Not yet recruitingNCT06746870Updated Dec 24, 2024

A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer

A Phase 2 interventional study of IMM2510 and Chemotherapy (pemetrexed + cisplatin/carboplatin) in NSCLC and TNBC, sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
148
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-arm, multicenter, open-label Phase II clinical study evaluating the efficacy and safety of IMM2510 in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic TNBC.

The target population includes: Cohort 1: Patients with histologically or cytologically confirmed stage IV metastatic or recurrent NSCLC who are EGFR wild-type and negative for ALK or ROS1 fusion genes, and who have not received prior systemic treatment for NSCLC; Cohort 2: Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic TNBC who are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2), and who have not received prior systemic treatment for TNBC; This study is divided into two phases. Phase I is the safety run-in period, which will preliminarily explore the safety and PK profile of IMM2510 in combination with chemotherapy in patients with NSCLC or TNBC who have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment, to determine the dose for the combination treatment. Phase II is the expanded enrollment period, which will enroll NSCLC patients (Cohort 1; where Cohort 1a is for NSQ-NSCLC and Cohort 1b is for SQ-NSCLC), or TNBC patients (Cohort 2), according to the dose for the combination treatment determined in Phase I, to further explore the preliminary clinical efficacy, safety, and PK profile of IMM2510 in combination with chemotherapy as first-line treatment in patients with NSCLC or TNBC.

02

Conditions studied

  • NSCLC
  • TNBC

Keywords

  • NSCLC
  • TNBC
  • IMM2510
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's planned enrollment of 148 is above the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc. is the lead sponsor of 21 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Fully understand and voluntarily sign the ICF for this study ;
  2. Aged ≥ 18 years old;
  3. Cohort 1: NSCLC; EGFR wild-type and negative for ALK or ROS1 fusion genes. Cohort 1a: Non-squamous NSCLC (NSQ-NSCLC); Cohort 1b: Squamous NSCLC (SQ-NSCLC); Cohort 2: Breast cancer, negative for ER, PR, and HER-2. Definition of negative for ER and PR: IHC ER \< 1%, IHC PR \< 1%. Definition of negative for HER-2: IHC HER-2 (-) or (1+); for HER-2 (2+), FISH testing must be performed and the result must be negative;
  4. Cohort 1: Previous systemic treatment for advanced NSCLC has not been received. If neoadjuvant and/or adjuvant treatment was previously received, the time from the completion of neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for NSCLC; Cohort 2: Previous systemic treatment for advanced TNBC has not been received. If neoadjuvant and/or adjuvant treatment included taxane-based anti-tumor treatment, the time from the completion of taxane-based neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for TNBC;
  5. ECOG score of 0 or 1;
  6. Have measurable lesions (according to RECIST 1.1).
  7. Expected survival ≥ 12 weeks;
  8. Provide archival tumor tissue samples or newly obtained needle biopsy or surgical resection samples of tumor lesions (previously unirradiated) for central PD-L1 and other biomarker tests. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred over slides. Newly obtained biopsy samples are preferred over archival samples. Formalin-fixed samples are preferred after the subject is diagnosed with metastatic disease. If a recent biopsy is not feasible, biopsy samples obtained prior to adjuvant/neoadjuvant chemotherapy are acceptable.
  9. Upon signing the ICF, females of childbearing potential and males must agree to practice effective contraception during the study and for 6 months after the last dose, and females of childbearing potential must have a negative result for pregnancy test within 3 days pre-dose;

Exclusion criteria

Exclusion Criteria:

  1. Received approved or investigational anti-tumor treatments within 4 weeks prior to the start of study treatment
  2. Received nonspecific immunomodulatory treatments within 2 weeks prior to the start of study treatment;
  3. Previously received any antibody or inhibitor targeting PD-1/PD-L1 or VEGF;
  4. Laboratory abnormalities
  5. History of pulmonary fibrosis or current presence of severe pulmonary functional impairment
  6. Uncontrolled chronic disease
  7. Unresolved toxicity
  8. Uncontrolled brain metastases
  9. Active infection
  10. Bleeding Risk
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    Cohort 1a

    NSQ-NSCLC

    Drug: IMM2510 · Drug: Chemotherapy (pemetrexed + cisplatin/carboplatin)

  • Experimental
    Cohort 1b

    SQ-NSCLC

    Drug: IMM2510 · Drug: Chemotherapy (paclitaxel + cisplatin/carboplatin)

  • Experimental
    Cohort 2

    TNBC

    Drug: IMM2510 · Drug: Chemotherapy(Nab-paclitaxel)

Interventions

  • DrugIMM2510

    Cohort1: Phase I #: 10 mg/kg or 20 mg/kg, Q3W, intravenous infusion Phase II \&: 20 mg/kg, Q3W, intravenous infusion Cohort2: Phase I #: 10 mg/kg or 20 mg/kg, Q2W, intravenous infusion Phase II \&: 20 mg/kg, Q2W, intravenous infusion

  • DrugChemotherapy (pemetrexed + cisplatin/carboplatin)

    Non-squamous non-small cell lung cancer (NQ-NSCLC): Pemetrexed 500 mg/m2 in combination with carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles, followed by maintenance treatment with pemetrexed

  • DrugChemotherapy (paclitaxel + cisplatin/carboplatin)

    Squamous non-small cell lung cancer (SQ-NSCLC): Paclitaxel 175 mg/m2 + carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles.

  • DrugChemotherapy(Nab-paclitaxel)

    Nab-paclitaxel, 100 mg/m2, 4 weeks as a cycle, administered on D1, 8, and 15 of each cycle.

06

What researchers measure

Primary outcomes

  1. To evaluate the preliminary clinical efficacy of IMM2510 for Injection in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent non-small cell lung cancer (NSCLC)

    Objective response rate for NSQ-NSCLC (ORR, assessed by the investigator) Objective response rate for SQ-NSCLC (ORR, assessed by the investigator)

    Time frame: 96 weeks

  2. To evaluate the preliminary clinical efficacy of IMM2510 for Injection in combination with nab-paclitaxel as first-line treatment in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)

    ORR (intention-to-treat (ITT), assessed by the investigator)

    Time frame: 96 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06746870
Lead sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Responsible party
Sponsor
First posted
Dec 24, 2024
Start date
Dec 2024 (estimated)
Primary completion
Nov 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 24, 2024

Study contacts

Qiying Lu, MD
Contact
qiying.lu@immuneonco.com
Qiying Lu, MD
study director · ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion