Small Cell Lung CarcinomaPhase 1NCT03319940
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
A Phase 1 study testing Tarlatamab, Pembrolizumab and CRS Mitigation Strategies in people with Small Cell Lung Carcinoma, run by Amgen at 39 sites in 13 countries.
Trial summary
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Tarlatamab, Pembrolizumab and CRS Mitigation Strategies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 39 sitesin 13 countries
- Study dates
- 26 Dec 2017to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures
- Age greater than or equal to 18 years old at the time of signing the informed consent
- Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants with treated brain metastases are eligible provided they meet defined criteria
- Adequate organ function as defined in protocol
Who cannot join
- History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
- Major surgery within 28 days of first dose tarlatamab
- Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
- Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
- Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis
Show all 9Show fewer
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
- Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
- Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration
Trial locations and contacts
39 sites in 13 countries.
39 sites in 13 countries
United States15 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
University of Chicago
Chicago, Illinois, 60637
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale New Haven Hospital
New Haven, Connecticut, 06510
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania, 15232
Washington University
St Louis, Missouri, 63110-1093
Moffitt Cancer Center
Tampa, Florida, 33612
Spain5 sites
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Japan3 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Tri-Service General Hospital
Taipei, 11490
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305
Austria2 sites
Medizinische Universitaet Graz
Graz, 8036
Landeskrankenhaus Salzburg
Salzburg, 5020
Netherlands2 sites
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, 1066 CX
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
Poland2 sites
Biokinetica SA
Józefów, 05-410
Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina
Otwock, 05-400
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Kantonsspital St Gallen
Sankt Gallen, 9007
About this study
Official title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Read the detailed description
This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Tarlatamab, Pembrolizumab, CRS Mitigation Strategies
- Keywords
- Half-Life Extended (HLE) Bispecific T cell engager (BiTE®), Delta-like protein 3 (DLL3), Tarlatamab, Oncology, Immunology
- Medical subject headings
- Small Cell Lung Carcinoma, Bites and Stings, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
PembrolizumabDrug
Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
CRS Mitigation StrategiesDrug
Participants will be treated with one of the CRS mitigation strategies.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Tarlatamab monotherapy Receives: Drug: Tarlatamab |
| Part C | Experimental | Tarlatamab with Pembrolizumab Receives: Drug: Tarlatamab; Drug: Pembrolizumab |
| Part D | Experimental | Tarlatamab with additional CRS mitigation strategies Receives: Drug: Tarlatamab; Drug: CRS Mitigation Strategies |
| Part E | Experimental | Tarlatamab administration with 24-hour monitoring Receives: Drug: Tarlatamab |
| Part F | Experimental | Tarlatamab administered in outpatient infusion centers with 8-hour monitoring
Optional wearable digital device substudy (US sites only) Receives: Drug: Tarlatamab |
| Part G | Experimental | Tarlatamab additional dosing schedule
Optional wearable digital device substudy (US sites only) Receives: Drug: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLT) for all indications
Measured: 6 months
Number of participants with treatment-emergent adverse events (AEs) for all indications
Measured: 4 years
Number of participants with treatment-related AEs for all indications
Measured: 4 years
Number of participants with clinically significant changes in vital signs for all indications
Measured: 4 years
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Measured: 4 years
Number of participants with significant changes in physical examinations for all indications
Measured: 4 years
Number of participants with significant changes in clinical laboratory tests for all indications
Measured: 4 years
Secondary outcomes (10)
Maximum observed concentration (Cmax) following intravenous administration for all indications
Measured: 4 years
Minimum observed concentration (Cmin) following intravenous administration for all indications
Measured: 4 years
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Measured: 4 years
Accumulation following multiple dosing for all indications
Measured: 4 years
Half-life (t1/2) following intravenous administration for all indications
Measured: 4 years
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Only for parts A, D, E, F, and G
Measured: 4 years
Duration of Response (DOR) for all indications
Measured: 4 years
Time to Response (TTR)
Measured: 4 years
9-month Progression-Free Survival (PFS) for all indications
Measured: 9 months
9-month Overall Survival (OS) for all indications
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start26 Dec 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional CRS mitigation strategies in participants with SCLC. The dose exploration phases of the study will estimate the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of tarlatamab either as monotherapy or in combination with pembrolizumab. This will be followed by dose expansion phase to confirm RP2D and to obtain further safety and efficacy data.
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319940
- Sponsor's protocol ID
- 20160323
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2017
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
- Expanded access
- Available
Publications
Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2.
PubMed 31215500Dowlati A, Hummel HD, Champiat S, Olmedo ME, Boyer M, He K, Steeghs N, Izumi H, Johnson ML, Yoshida T, Bouchaab H, Borghaei H, Felip E, Jost PJ, Gadgeel S, Chen X, Yu Y, Martinez P, Parkes A, Paz-Ares L. Sustained Clinical Benefit and Intracranial Activity of Tarlatamab in Previously Treated Small Cell Lung Cancer: DeLLphi-300 Trial Update. J Clin Oncol. 2024 Oct 10;42(29):3392-3399. doi: 10.1200/JCO.24.00553. Epub 2024 Aug 29.
PubMed 39208379Paz-Ares L, Champiat S, Lai WV, Izumi H, Govindan R, Boyer M, Hummel HD, Borghaei H, Johnson ML, Steeghs N, Blackhall F, Dowlati A, Reguart N, Yoshida T, He K, Gadgeel SM, Felip E, Zhang Y, Pati A, Minocha M, Mukherjee S, Goldrick A, Nagorsen D, Hashemi Sadraei N, Owonikoko TK. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023 Jun 1;41(16):2893-2903. doi: 10.1200/JCO.22.02823. Epub 2023 Jan 23.
PubMed 36689692Chiang AC, Olmedo Garcia ME, Carlisle JW, Dowlati A, Reguart N, Felip E, Jost PJ, Steeghs N, Stec R, Gadgeel SM, Loong HH, Jiang W, Hamidi A, Parkes A, Paz-Ares L. Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy. ESMO Open. 2025 Apr;10(4):104538. doi: 10.1016/j.esmoop.2025.104538. Epub 2025 Apr 4.
PubMed 40187110
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
- ClinicalTrials.gov ID
- NCT03319940
- Acronym / sponsor ID
- 20160323
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Half-Life Extended (HLE) Bispecific T cell engager (BiTE®), Delta-like protein 3 (DLL3), Tarlatamab, Oncology, Immunology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 269 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Oct 2017 (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 study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Detailed description
This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional CRS mitigation strategies in participants with SCLC. The dose exploration phases of the study will estimate the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of tarlatamab either as monotherapy or in combination with pembrolizumab. This will be followed by dose expansion phase to confirm RP2D and to obtain further safety and efficacy data.
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: TarlatamabTarlatamab monotherapy |
| Part C | Experimental | Drug: Tarlatamab, Drug: PembrolizumabTarlatamab with Pembrolizumab |
| Part D | Experimental | Drug: Tarlatamab, Drug: CRS Mitigation StrategiesTarlatamab with additional CRS mitigation strategies |
| Part E | Experimental | Drug: TarlatamabTarlatamab administration with 24-hour monitoring |
| Part F | Experimental | Drug: TarlatamabTarlatamab administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only) |
| Part G | Experimental | Drug: TarlatamabTarlatamab additional dosing schedule Optional wearable digital device substudy (US sites only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures
- Age greater than or equal to 18 years old at the time of signing the informed consent
- Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants with treated brain metastases are eligible provided they meet defined criteria
Key exclusion criteria (9 listed)
- History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
- Major surgery within 28 days of first dose tarlatamab
- Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
- Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
- Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
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 |
|---|---|---|
| TarlatamabTarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3) | Drug | Part A, Part C, Part D, Part E, Part F, Part G |
| PembrolizumabPembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2 | Drug | Part C |
| CRS Mitigation StrategiesParticipants will be treated with one of the CRS mitigation strategies. | Drug | Part D |
Primary outcome
Number of participants with dose limiting toxicities (DLT) for all indications
Time frame: 6 months
Number of participants with treatment-emergent adverse events (AEs) for all indications
Time frame: 4 years
Number of participants with treatment-related AEs for all indications
Time frame: 4 years
Number of participants with clinically significant changes in vital signs for all indications
Time frame: 4 years
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Time frame: 4 years
Number of participants with significant changes in physical examinations for all indications
Time frame: 4 years
Number of participants with significant changes in clinical laboratory tests for all indications
Time frame: 4 years
10 secondary outcomes
Maximum observed concentration (Cmax) following intravenous administration for all indications
Time frame: 4 years
Minimum observed concentration (Cmin) following intravenous administration for all indications
Time frame: 4 years
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Time frame: 4 years
Accumulation following multiple dosing for all indications
Time frame: 4 years
Half-life (t1/2) following intravenous administration for all indications
Time frame: 4 years
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 4 years
Duration of Response (DOR) for all indications
Time frame: 4 years
Time to Response (TTR)
Time frame: 4 years
9-month Progression-Free Survival (PFS) for all indications
Time frame: 9 months
9-month Overall Survival (OS) for all indications
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 31215500Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2.
- Background: PubMed 39208379Dowlati A, Hummel HD, Champiat S, Olmedo ME, Boyer M, He K, Steeghs N, Izumi H, Johnson ML, Yoshida T, Bouchaab H, Borghaei H, Felip E, Jost PJ, Gadgeel S, Chen X, Yu Y, Martinez P, Parkes A, Paz-Ares L. Sustained Clinical Benefit and Intracranial Activity of Tarlatamab in Previously Treated Small Cell Lung Cancer: DeLLphi-300 Trial Update. J Clin Oncol. 2024 Oct 10;42(29):3392-3399. doi: 10.1200/JCO.24.00553. Epub 2024 Aug 29.
- Background: PubMed 36689692Paz-Ares L, Champiat S, Lai WV, Izumi H, Govindan R, Boyer M, Hummel HD, Borghaei H, Johnson ML, Steeghs N, Blackhall F, Dowlati A, Reguart N, Yoshida T, He K, Gadgeel SM, Felip E, Zhang Y, Pati A, Minocha M, Mukherjee S, Goldrick A, Nagorsen D, Hashemi Sadraei N, Owonikoko TK. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023 Jun 1;41(16):2893-2903. doi: 10.1200/JCO.22.02823. Epub 2023 Jan 23.
- Background: PubMed 40187110Chiang AC, Olmedo Garcia ME, Carlisle JW, Dowlati A, Reguart N, Felip E, Jost PJ, Steeghs N, Stec R, Gadgeel SM, Loong HH, Jiang W, Hamidi A, Parkes A, Paz-Ares L. Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy. ESMO Open. 2025 Apr;10(4):104538. doi: 10.1016/j.esmoop.2025.104538. Epub 2025 Apr 4.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
39 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tarlatamab, Pembrolizumab and CRS Mitigation Strategies in people with Small Cell Lung Carcinoma, run by Amgen at 39 sites in 13 countries.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Spain, Japan, Taiwan, Austria and 8 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with dose limiting toxicities (DLT) for all indications (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319940, which also lists 4 linked publications.
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 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.