Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors (BMD-PLAT)

A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors

This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Neoplasm Metastasis; Solid Tumors
• Intervention / Treatment: Biological: Inhaled mRNA

Detailed Description

This is an open-label, single-arm, phase I master platform clinical trial designed to assess the safety, tolerability, pharmacokinetic profiles and preliminary anti-tumor activity of multiple investigational inhaled in-vivo mRNA multi-target immunotherapy candidates in adult subjects diagnosed with unresectable locally advanced or metastatic solid tumors.

The study adopts the standard 3+3 dose-escalation design for each individual mRNA product. Eligible participants will receive study drug via pulmonary inhalation on predefined treatment cycles with gradual dose increment across sequential cohorts to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). After completion of dose escalation, an optional expansion cohort at RP2D will be enrolled to further characterize safety and preliminary anti-tumor efficacy.

All enrolled patients will undergo regular safety monitoring including adverse event recording, laboratory examinations, pulmonary function test and radiological tumor assessment per protocol schedule. The primary study endpoints focus on treatment-related adverse events and MTD determination; secondary endpoints include objective response rate, disease control rate, duration of response as well as pharmacokinetic parameters of inhaled mRNA agents. Subjects will continue assigned study treatment until confirmed disease progression, unacceptable toxicity, withdrawal of consent or study closure.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients aged ≥ 18 years.
2. Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.
3. Presence of at least one measurable lesion according to RECIST v1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Adequate organ function, including hematologic, hepatic, and renal function.
6. Ability to understand and sign the informed consent form.
7. Expected survival of at least 12 weeks.

Exclusion Criteria:

1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug.
2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).
3. Prior allogeneic stem cell or solid organ transplantation.
4. Current use of other investigational agents within 4 weeks before the first dose of study treatment.
5. Active autoimmune disease requiring systemic immunosuppressive therapy.
6. Pregnant or breastfeeding women.
7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Inhaled mRNA Immunotherapy; All enrolled subjects will receive inhaled mRNA immunotherapy via Breezhaler dry powder inhaler.; Intervention 1: BMD007-T1 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.; Intervention 2: BMD014-T5 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter.; Intervention 3: BMD013-T3 mRNA dry powder, 300 mcg per capsule, administered on Days 1 and 7, then weekly thereafter. Dose escalation will follow a standard 3+3 design. Treatment duration will not exceed 52 weeks.

Biological: Inhaled mRNA; Inhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	The primary endpoint is to assess the safety and tolerability of inhaled mRNA immunotherapy, including the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).	From the first dose of study treatment up to 30 days after the last dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)	To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of inhaled mRNA immunotherapy using a standard 3+3 dose-escalation design.	Up to 28 days after the last dose in each dose cohort.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: NCC6293 (Other Identifier: National Cancer Center/Cancer Hospital, CAMS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No