Clinical trial · Interventional

Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors

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

NCT07657611CI-TRIAL-00115295BMD-PLATnot yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoplasm Metastasis	—	UNRESOLVED	—
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90
Solid Tumors	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Inhaled mRNA	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Inhaled mRNA Immunotherapy
description
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.
interventionNames
1. Biological: Inhaled mRNA

Primary outcomes (1)

measure
Safety and Tolerability
timeFrame
From the first dose of study treatment up to 30 days after the last dose.
description
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).

Secondary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.