Clinical trial · Interventional

A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer

An Open-label Phase Ib Study on the Safety, Tolerability, and Efficacy of BT02 in Treating Patients With Advanced Lung Cancer

NCT07110363CI-TRIAL-00093265not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The goal of this clinical trial is to assess whether an investigational treatment is safe and tolerable for patients with advanced lung cancer, and to get a preliminary idea of its effectiveness. Participants of all genders, aged between 18 and 75(inclusive), are eligible to join. These patients will receive the investigational drug intravenously every two weeks. If their condition doesn't worsen and they don't experience unbearable side effects, they can continue the treatment for up to two years.

Conditions

Conditions (4)

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

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Lung Cancer	Malignant Lung Neoplasm	CURATED_BROADER	0.78
Advanced Malignant Solid Tumor	Malignant Solid Neoplasm	CURATED_BROADER	0.80
Non-Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90
Small Cell Lung Cancer	Lung Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
BT02	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
dose escalation and expansion
interventionNames
1. Drug: BT02

Primary outcomes (4)

measure
Adverse events
timeFrame
through study completion, an average of 2 years
measure
Dose limited toxicity incidence
timeFrame
Through the dose escalation phase , an average of 8 months
measure
Maximum tolerated dose(MTD)
timeFrame
Through the dose escalation phase, an average of 8 months
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients with pathologically confirmed locally advanced/unresectable or metastatic or recurrent non-small cell lung cancer (NSCLC, according to AJCC TNM staging) and advanced/unresectable limited-stage or extensive-stage small cell lung cancer (SCLC, according to VALG combined with AJCC TNM staging)，who have failed in the prior systemic therapy .
2. Adequate organ and hematologic function.
3. At least 1 extracranial measurable lesion.
4. An ECOG activity status score of 0-1.
5. A life expectancy of ≥ 3 months.
6. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
7. Good compliance and willingness to follow up.

Exclusion Criteria:

1. Patients with sensitive mutations or gene fusions related to lung cancer.
2. Prior to the first dose , received systemic antitumor therapy, scheduled major surgical procedure within 4 weeks, received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
3. A history of active autoimmune disease within the past 2 years.
4. A history of clinically significant cardiovascular disease, severe cardiac rhythm /conduction abnormalities or LVEF \<50% . A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
5. A severe acute or chronic infection when enrollment.
6. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
7. Unresolved \> Grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
8. Clinically active CNS metastases or meningeal metastases.
9. A history of other type of malignancies.
10. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
11. Poor compliance.
12. A history of alcohol or drugs abuse.
13. Current pregnancy or breastfeeding.
14. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.

References

Publications (0)

Data not yet available

No reference posted for this study.