Non-small Cell Lung Cancer MetastaticPhase 1NCT06083870
An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
A Phase 1 study testing Oba01 in people with Non-small Cell Lung Cancer Metastatic, run by Lu Shun at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Oba01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2023to Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, 200030
Shun Lu, 86-21-22200000, shunlu@sjtu.edu.cn
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- Oba01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oba01Drug
Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Oba01 | Experimental | Not described Receives: Drug: Oba01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal tolerance dose (MTD) of Oba01
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
Measured: DLT will be evaluated on 21 days of observation period
Secondary outcomes (5)
Overall response rate(ORR)
The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.
Measured: Up to approximately 2 years
Disease control rate (DCR)
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
Measured: Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Measured: Up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival (PFS) refers to the time from the date of first dose to the first researcher's evaluation of disease progression or death.
Measured: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS) refers to the time from the date of first dose to death.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start13 Dec 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Shun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Shun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083870
- Sponsor's protocol ID
- RC248-C001
- Status last verified
- Dec 2023
- First submitted
- 9 Oct 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA/mNSCLC
- ClinicalTrials.gov ID
- NCT06083870
- Acronym / sponsor ID
- RC248-C001
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Lu ShunUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA/mNSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oba01 | Experimental | Drug: Oba01 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oba01Oba01 0.15, 0.5, 0.75, 1.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle | Drug | Oba01 |
Primary outcome
maximal tolerance dose (MTD) of Oba01
Time frame: DLT will be evaluated on 21 days of observation period
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
5 secondary outcomes
Overall response rate(ORR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oba01 in people with Non-small Cell Lung Cancer Metastatic, run by Lu Shun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shun Lu, PhD (86-21-62821990 ext. 15216769608, shunlu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal tolerance dose (MTD) of Oba01 (time frame: DLT will be evaluated on 21 days of observation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.