Lung CancerPhase 2NCT06555263
Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing Luveltamab tazevibulin in people with Lung Cancer and Lung Cancer Metastatic, run by Sutro Biopharma, Inc. at 7 sites in United States.
Trial summary
A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Nonsmall Cell
- What is being tested?
- Luveltamab tazevibulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Aug 2024to 1 May 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed non-squamous/adenocarcinoma or adenosquamous NSCLC that is either unresectable Stage IIIb/c disease not amenable for definitive chemoradiation, or Stage IV.
- Age ≥ 18 years
- ECOG performance status 0 to 1.
- Received at least 2 but no more than 4 prior lines of systemic therapy for advanced NSCLC
- Disease progression during or following the most recent systemic anti-cancer therapy.
- Positive FOLR1 expression per central testing
- At least 1 measurable target lesion per RECIST 1.1
- Adequate organ function
Who cannot join
- Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
- Untreated central nervous system metastases
- Ongoing immunosuppressive therapy, except for treated brain metastases, per criterion above.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
- Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
- Previous solid organ transplantation
- Concurrent participation in another therapeutic treatment trial
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
UC San Diego Health - Moores Cancer Center
La Jolla, California, 92037
Florida Cancer Specialists & Research Institute (FCS)
Lake Mary, Florida, 32746
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
Tampa General Hospital - Cancer Center of South Florida
Tampa, Florida, 33606
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20057
About this study
Official title: A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects With Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1
A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1
Read the detailed description
This is a multicenter, open-label study. The study is designed to assess the preliminary efficacy and safety of luveltamab tazevibulin, an anti-FOLR1 antibody drug conjugate (ADC) in previously treated subjects with advanced or metastatic NSCLC that expresses FOLR1.
Subjects will receive luveltamab tazevibulin administered intravenously every 3 weeks until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.
- Conditions
- Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Nonsmall Cell, Lung Cancer Non-Small Cell Stage IIIB, Lung Cancer Non-small Cell Stage IV, Lung Cancer, Non-small Cell
- Being tested
- Luveltamab tazevibulin
- Keywords
- FOLR1, folate receptor alpha, FolRα, FRα, antibody drug conjugate, ADC, Luveltamab tazevibulin, STRO-002, Luvelta
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luveltamab tazevibulinDrug
Also called STRO-002, luvelta
Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.
| Study group | Role | What they receive |
|---|---|---|
| Luveltamab tazevibulin | Experimental | 4.3 mg/kg q3w
Eligible subjects with stable disease (SD) may escalate to 5.2 mg/kg q3w after Cycle 4, with Sponsor approval. Receives: Drug: Luveltamab tazevibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Measured: up to 24 months
Secondary outcomes (6)
Duration of Response (DOR) per Investigator's assessment.
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Measured: up to 24 months
Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment.
Time between the date of first dose and the first date of documented progression or death
Measured: up to 24 months
Incidence and severity of adverse events and clinical laboratory abnormalities
Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.
Measured: up to 24 months
ADC concentration
To evaluate the PK of luveltamab tazevibulin
Measured: up to 24 months
Total antibody concentration
To evaluate the PK of luveltamab tazevibulin
Measured: up to 24 months
Cytotoxic warhead concentration
To evaluate the PK of luveltamab tazevibulin
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start21 Aug 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: Terminated Early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sutro Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555263
- Sponsor's protocol ID
- REFRaME-L1
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects With Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1
- ClinicalTrials.gov ID
- NCT06555263
- Acronym / sponsor ID
- REFRaME-L1
- Conditions
- Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Nonsmall Cell, Lung Cancer Non-Small Cell Stage IIIB, Lung Cancer Non-small Cell Stage IV, Lung Cancer, Non-small Cell
- Keywords
- FOLR1, folate receptor alpha, FolRα, FRα, antibody drug conjugate, ADC, Luveltamab tazevibulin, STRO-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated Early
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sutro Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 Aug 2024 (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.
A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1
Detailed description
This is a multicenter, open-label study. The study is designed to assess the preliminary efficacy and safety of luveltamab tazevibulin, an anti-FOLR1 antibody drug conjugate (ADC) in previously treated subjects with advanced or metastatic NSCLC that expresses FOLR1.
Subjects will receive luveltamab tazevibulin administered intravenously every 3 weeks until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luveltamab tazevibulin | Experimental | Drug: Luveltamab tazevibulin4.3 mg/kg q3w Eligible subjects with stable disease (SD) may escalate to 5.2 mg/kg q3w after Cycle 4, with Sponsor approval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed non-squamous/adenocarcinoma or adenosquamous NSCLC that is either unresectable Stage IIIb/c disease not amenable for definitive chemoradiation, or Stage IV.
- Age ≥ 18 years
- ECOG performance status 0 to 1.
- Received at least 2 but no more than 4 prior lines of systemic therapy for advanced NSCLC
- Disease progression during or following the most recent systemic anti-cancer therapy.
Key exclusion criteria (7 listed)
- Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
- Untreated central nervous system metastases
- Ongoing immunosuppressive therapy, except for treated brain metastases, per criterion above.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
- Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
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 |
|---|---|---|
| Luveltamab tazevibulinAlso: STRO-002, luveltaLuveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death. | Drug | Luveltamab tazevibulin |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 24 months
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
6 secondary outcomes
Duration of Response (DOR) per Investigator's assessment.
Time frame: up to 24 months
Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment.
Time frame: up to 24 months
Incidence and severity of adverse events and clinical laboratory abnormalities
Time frame: up to 24 months
ADC concentration
Time frame: up to 24 months
Total antibody concentration
Time frame: up to 24 months
Cytotoxic warhead concentration
Time frame: up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luveltamab tazevibulin in people with Lung Cancer and Lung Cancer Metastatic, run by Sutro Biopharma, Inc. at 7 sites in United States.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 24 months). 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 22 Aug 2025.