IBI363 for Squamous Lung Cancer

(MarsLight-11 Trial)

Not yet recruiting at 1 trial location

Overseen By Farah Dahman, MPA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Fortvita Biologics (USA)Inc.

Must not be taking: Docetaxel, Immunosuppressants, Steroids, others

Disqualifiers: Pregnancy, Brain metastases, Cardiovascular diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 44 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IBI363 for individuals with advanced squamous non-small cell lung cancer. It compares IBI363 to the standard chemotherapy drug docetaxel to determine which is more effective after other treatments have failed. IBI363 aims to help the immune system fight cancer by targeting specific cells. Individuals with this type of lung cancer who have previously undergone chemotherapy and immunotherapy without success might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing patients an opportunity to access a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, certain treatments like chemotherapy, anti-tumor antibody therapy, and immunosuppressive therapy must not be taken shortly before starting the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IBI363 may help treat squamous lung cancer. In earlier studies, patients generally tolerated IBI363 well. Common side effects included tiredness and nausea, but these were usually mild and manageable. The FDA has fast-tracked IBI363, indicating that early data suggests it could be safe and effective. While this is a positive sign, it doesn't guarantee success.

IBI363 targets certain proteins to help the body's immune system fight cancer cells. This new method has shown promising results in lab tests and initial patient studies. If side effects occur, adjusting the dosage can improve tolerance.

Overall, IBI363 appears to be a promising option for those who haven't had success with standard treatments. Always consult a healthcare provider about the potential risks and benefits before deciding to join a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Most treatments for squamous lung cancer, like chemotherapy with docetaxel, focus on killing cancer cells directly. But IBI363 works differently, targeting the immune system. It's a bispecific monoclonal antibody that simultaneously blocks the PD-(L)1 pathway and activates the IL-2 pathway. This dual action is designed to wake up exhausted T cells and natural killer cells, making them more effective at attacking cancer cells. Researchers are excited because this approach could lead to better outcomes by harnessing the body's own immune response to fight the cancer.

What evidence suggests that this trial's treatments could be effective for squamous lung cancer?

This trial will compare IBI363, a new treatment, with Docetaxel, the control treatment. Research has shown that IBI363 produced promising results in earlier studies. It targets specific immune system cells to help fight cancer. In patients with difficult-to-treat melanoma, IBI363 improved outcomes when other treatments failed. The FDA recognized its potential by granting fast track status for advanced squamous lung cancer, suggesting that IBI363 could also be effective for this type of lung cancer. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

Adults with advanced squamous Non-Small Cell Lung Cancer who've seen their cancer progress after platinum chemotherapy and PD-1/PD-L1 immunotherapy. Participants should not have had prior treatments that would interfere with the trial, and they must be able to handle the side effects of treatment.

Inclusion Criteria

Willing to sign the written informed consent form and be able to comply with the visit schedule and related procedures specified in the protocol

Expected survival time ≥ 3 months

Lactating women must agree to strictly abstain from breastfeeding during the entire Treatment Period and for 6 months after the treatment

Exclusion Criteria

Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation

Known or suspected allergy to the investigational medical product and any excipients

History or current evidence of any disease, treatment, or laboratory abnormality that could compromise safety, interfere with obtaining informed consent, affect compliance, or affect safety evaluations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IBI363 or Docetaxel. IBI363 involves a priming dose followed by a 3 mg/kg dose every 3 weeks, with cycle durations of 28 days for Cycle 1 and 21 days thereafter. Docetaxel is administered at 75 mg/m² every 3 weeks.

44 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of adverse events and overall survival.

44 months

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• IBI363

Trial Overview The trial is testing IBI363 against Docetaxel in patients whose lung cancer has worsened despite standard treatments. It's a phase 3 study where participants are randomly chosen to receive either IBI363 or Docetaxel, following specific dosing schedules and adjustments based on side effects.

How Is the Trial Designed?

Group I: IBI363 Experimental Treatment 1 Intervention

IBI363 is a first-in-class bispecific monoclonal antibody (mAb) comprised of an interleukin-2 (IL-2) mutein fused with a recombinant anti-programmed cell death protein 1 (anti-PD-1) mAb. IBI363 was precisely designed and constructed to afford targeted binding of tumor-specific CD8+ T cells (TSTs) that co-express PD-1 and CD25 (IL2Ra) receptors. The mechanism of action of IBI363 is blocking the PD-(L)1 and activating the IL-2 pathways simultaneously to reverse T cell exhaustion and promote activation of T cells and natural killer (NK) cells, and consequently eliminate tumor cells.

Group II: Control Active Control 1 Intervention

Docetaxel or comparable generic brand

Who Is Running the Clinical Trial?

Fortvita Biologics (USA)Inc.

Lead Sponsor

Trials

1

Recruited

80+

Innovent Biologics (Suzhou) Co. Ltd.

Industry Sponsor

Trials

184

Recruited

28,300+

Dr. Michael Yu

Innovent Biologics (Suzhou) Co. Ltd.

Chief Executive Officer since 2011

PhD in Molecular Biology

Dr. Nageatte Ibrahim

Innovent Biologics (Suzhou) Co. Ltd.

Chief Medical Officer

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217301

Study Details | NCT07217301 | IBI363 vs Docetaxel in ... IBI363 is a first-in-class bispecific monoclonal antibody (mAb) comprised of an interleukin-2 (IL-2) mutein fused with a recombinant anti- ...

2. prnewswire.com prnewswire.com/news-releases/asco-2025-oral-presentation-innovent-biologics-announces-updated-data-of-ibi363-first-in-class-pd-1il-2--bias-bispecific-antibody-fusion-protein-from-phase-1-and-2-clinical-studies-on-immunotherapy-treated-advanced-malignant--302470081.html

ASCO 2025 Oral Presentation: Innovent Biologics ... IBI363 has shown breakthrough efficacy in patients with heavily-treated melanoma subtypes - which are traditionally treatment-resistant cold tumors.

3. cancernetwork.com cancernetwork.com/view/fda-clears-ind-for-ibi363-in-squamous-non-small-cell-lung-cancer

FDA Clears IND for IBI363 in Squamous Non–Small Cell ... Investigators of the trial will assess the safety and efficacy of IBI363 at a dose of 3 mg/kg vs docetaxel among patients with unresectable, ...

4. asco.org asco.org/videos-slides/VIDEOSANDSLIDES246467

First-in-class PD-1/IL-2 bispecific antibody IBI363 ... - ASCO First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC). Sign in to explore ...

5. targetedonc.com targetedonc.com/view/fda-fast-tracks-ibi363-in-squamous-nsclc

FDA Fast-Tracks IBI363 in Squamous NSCLC The FDA granted fast track status to IBI363 for the treatment of patients with advanced squamous lung cancer after prior treatment.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8509

First-in-class PD-1/IL-2 bispecific antibody IBI363 ... IBI363 is a first-in-class PD-1/IL-2 α-bias bispecific antibody fusion protein to block PD-1 checkpoint and rejuvenate exhausted tumor-specific T cells.

7. prnewswire.com prnewswire.com/news-releases/2025-asco-oral-presentation-innovent-biologics-announces-updated-data-of-ibi363-first-in-class-pd-1il-2-bias-bispecific-antibody-fusion-protein-from-the-phase-1-poc-clinical-study-in-advanced-non-small-cell-lung-cancer-302472525.html

2025 ASCO Oral Presentation: Innovent Biologics ... IBI363 showed breakthrough therapeutic potential from tumor response to long-term survival benefit in immuno-resistant squamous NSCLC.