An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC

Lu Shun

Status and phase

Enrolling

Phase 1

Conditions

Non-small Cell Lung Cancer Metastatic

Treatments

Drug: Oba01

Study type

Interventional

Funder types

Other

Identifiers

RC248-C001

Details and patient eligibility

About

This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntary agreement to provide written informed consent.
Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment.
Histologically and/or cytologically-confirmed locally advanced or metastatic NSCLC.
Measurable lesion according to RECIST 1.1.
Progression after systemic treatment for advanced NSCLC.
Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Measurable and/or non-measurable disease as per RECIST 1.1 criteria.
Adequate organ function as assessed by laboratory tests.
Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.

Exclusion criteria

Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate.
Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment.
Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA > ULN.
Pregnancy, lactation, or breastfeeding.