Solid TumorPhase 1/2NCT07739966
A Study of DS-3939a in Participants With Solid Tumors
A Phase 1/2 study testing DS-3939a, Pembrolizumab and Carboplatin in people with Solid Tumor and Locally Advanced Non-Small Cell Lung Cancer, run by Daiichi Sankyo at 76 sites in 13 countries.
Trial summary
The primary purpose of the study is to evaluate the safety, tolerability, and efficacy of DS-3939a in combination with other anticancer agents or as a monotherapy in participants with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- DS-3939a, Pembrolizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 76 sitesin 13 countries
- Study dates
- 13 Oct 2026to 29 Jan 2032
- Phase
- Phase 1/2
- 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
- Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.
- Adults greater than or equal to (≥)18 years of age at the time the Main Trial ICF is signed (follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).
- Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC.
- Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days of the first trial intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions.
- Has adequate organ function.
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- Participants must have measurable disease by investigator assessment according to RECIST v1.1.
- Additional Inclusion Criteria for Substudy 1:
- 1. Participants must not have received prior systemic therapy for locally advanced unresectable or metastatic NSCLC.
- Additional Inclusion Criteria for Substudy 2:
- Participants with AGA (excluding EGFR mutation): Participants have been previously treated with targeted therapy for the AGA and platinum-based chemotherapy for the advanced disease setting.
- Participants without AGA: Participants have been previously treated with platinum-based chemotherapy and anti-programmed death-1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) antibody
- Part 2 only: Participants must have received only 1 or 2 prior lines of anticancer therapy for the advanced disease setting.
Who cannot join
- Prior systemic anticancer therapy targeting MUC1 or TA-MUC1.
- Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan).
- Has spinal cord compression or clinically active central nervous system (CNS) metastases.
- Has multiple primary malignancies.
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening
- Has active or uncontrolled human immunodeficiency virus (HIV) infection.
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- Has active or uncontrolled hepatitis B virus (HBV)/hepatitis C virus (HCV) infection.
- Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- Current participation in other therapeutic investigational procedures, except for participation in long term survival follow-up (LTSFU) without any investigational treatment.
Trial locations and contacts
76 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
76 sites in 13 countries
China15 sites, 15 recruiting
- Not yet recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, 101149
- Not yet recruiting
Jilin Cancer Hospital
Changchun, 130012
- Not yet recruiting
Hunan Cancer Hospital
Changsha, 410013
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, 510080
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine (Zhejiang Provincial First Hos
Hangzhou, 310006
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, 150040
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Hexi District, Tianjin, 300060
- Not yet recruiting
Jiamusi Cancer Hospital
Jiamusi, 154000
- Not yet recruiting
Shandong University - Shandong Cancer Hospital
Jinan, 250117
- Not yet recruiting
Lin Yi Cancer Hospital
Linyi, 276000
- Not yet recruiting
Shanghai East Hospital
Shanghai, 200120
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, 317000
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, 430079
- Not yet recruiting
Henan Provincial Cancer Hospital
Zhengzhou, 450008
France8 sites, 8 recruiting
- Not yet recruiting
Aphm - Hopital Nord
Marseille, 13005
- Not yet recruiting
Centre Hospitalier Universitaire de Montpellier (Chu Montpellier) - Hopital Lapeyronie
Montpellier, 34090
- Not yet recruiting
Hospitalier Paris Saint-Joseph
Paris, 75014
- Not yet recruiting
Centre Hospitalier Universitaire (Chu) de Rennes - Hopital de Pontchaillou
Rennes, 35000
- Not yet recruiting
Institut de Cancerologie de L'Ouest (Ico) - Saint-Herblain
Saint-Herblain, 44800
- Not yet recruiting
Hopital Foch
Suresnes, 92150
- Not yet recruiting
Unicancer-Institut de Cancerologie de Lorraine (Icl)
Vandœuvre-lès-Nancy, 54500
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94805
Spain8 sites, 8 recruiting
- Not yet recruiting
Hospital Del Mar
Barcelona, 8003
- Not yet recruiting
Hospital Universitario Arnau de Vilanova (Lleida)
Lleida, 25198
- Not yet recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
- Not yet recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Not yet recruiting
Hospital Universitario Virgen de La Victoria
Málaga, 90095
- Not yet recruiting
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15705
- Not yet recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
- Not yet recruiting
Hospital Universitario Virgen Del Rocio (Huvr)
Seville, 41013
United States7 sites, 7 recruiting
- Not yet recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
- Recruiting
Highlands Oncology Group (Hog) - Fayetteville
Fayetteville, Arkansas, 72703-4005
- Not yet recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030
- Not yet recruiting
UCLA Health
Los Angeles, California, 90095
- Not yet recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Not yet recruiting
Lifespan Cancer Institute - Rhode Island Hospital
Providence, Rhode Island, 02903
- Not yet recruiting
Moffitt Cancer Center - Magnolia Campus
Tampa, Florida, 33612
Italy7 sites, 7 recruiting
- Not yet recruiting
Istituto Europeo Di Oncologia
Milan, 20141
- Not yet recruiting
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, 10043
- Not yet recruiting
Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo
Pavia, 27100
- Not yet recruiting
Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
Perugia, 6129
- Not yet recruiting
Servizio Sanitario Regionale Emilia-Romagna - Azienda Unita Sanitaria Locale Della Romagna - Ospedal
Ravenna, 48121
- Not yet recruiting
Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
Rome, 144
- Not yet recruiting
Fondazione Policlinico Universitario Agostino
Rome, 168
Brazil6 sites, 6 recruiting
- Not yet recruiting
Fundacao Pio Xii-Hospital de Cancer de Barretos
Barretos, 14784-400
- Not yet recruiting
Liga Norte Riograndense Contra O Cancer - Pesquisa Clinica
Natal, 59040-011
- Not yet recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090
- Not yet recruiting
Hospital Sao Lucas Da Pucrs
Porto Alegre, 95700-068
- Not yet recruiting
Obras Sociais Irma Dulce - Centro de Pesquisa Oncologica E Clinica (Cpoc)
Salvador, 40444-130
- Not yet recruiting
Hospital Israelita Albert Einstein
São Paulo, 05503-900
Turkey (Türkiye)6 sites, 6 recruiting
- Not yet recruiting
Memorial Ankara Hospital
Ankara, 6520
- Not yet recruiting
Liv Hospital Ankara
Ankara, 6680
- Not yet recruiting
T.C. Saglik Bakanligi Ankara Ataturk Egitim Ve Arastirma Hastanesi (Ankara Ataturk Training and Rese
Ankara, 6800
- Not yet recruiting
Ege Universitesi Tip Fakultesi Hastanesi
Bornova, 35100
- Not yet recruiting
Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34722
- Not yet recruiting
Adana City Training & Research Hospital
Yüreğir, 1370
Argentina5 sites, 5 recruiting
- Not yet recruiting
Instituto Alexander Fleming
Buenos Aires, C1426ANZ
- Not yet recruiting
Instituto Oncologico de Cordoba (Ionc) - Fundacion Richardet Longo
Córdoba, 5000
- Not yet recruiting
Sanatorio Parque
Rosario, S2000
- Not yet recruiting
Cer San Juan - Centro Polivalente de Asistencia E Investigacion Clinica
San Juan, J5402DIL
- Not yet recruiting
Clinica Viedma S.A.
Viedma, R8500
Japan5 sites, 5 recruiting
- Not yet recruiting
Kansai Medical University Hospital
Hirakata, 573-1191
- Not yet recruiting
National Cancer Center Hospital East
Kashiwa-shi, 277-8577
- Not yet recruiting
National Hospital Organization (Nho) Shikoku Cancer Center
Matsuyama, 791-0280
- Not yet recruiting
Sendai Kousei Hospital
Sendai, 980-0873
- Not yet recruiting
National Hospital Organization Hokkaido Cancer Center
Shiroishi-ku, Sapporo-shi, 003-0804
Taiwan4 sites, 4 recruiting
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Not yet recruiting
National Cheng Kung University Hospital Nckuh
Tainan, 704031
- Not yet recruiting
National Taiwan University Hospital
Taipei, 100021
- Not yet recruiting
Taipei Veterans General Hospital
Taipei, 11217
Austria2 sites, 2 recruiting
- Not yet recruiting
Medizinische Universitat Innsbruck
Innsbruck, 4302
- Not yet recruiting
Karl Landsteiner Institut Fur Lungenforschung Und Pneumologische Onkologie
Vienna, 1210
Belgium2 sites, 2 recruiting
- Not yet recruiting
Universite Libre de Bruxelles (Ulb) - Institut Jules
Brussels, 1070
- Not yet recruiting
Jessa Ziekenhuis - Hartcentrum Hasselt
Sint-Truiden, 3800
Tunisia1 site, 1 recruiting
- Not yet recruiting
Ankara Bilkent Sehir Hastanesi (Ankara City Hospital)
Ankara, 6800
About this study
Official title: A Phase 1b/2, Multicenter, 2-part, Open-label Trial to Evaluate DS-3939a in Participants With Solid Tumors
The primary purpose of the study is to evaluate the safety, tolerability, and efficacy of DS-3939a in combination with other anticancer agents or as a monotherapy in participants with solid tumors.
Read the detailed description
The study includes 2 independent substudies, which have been defined by treatment combination and participant population as follows:
- Substudy 1 will evaluate the safety and efficacy of DS-3939a in combination with immunotherapy with or without chemotherapy (carboplatin or pemetrexed) in participants with locally advanced unresectable or metastatic non-squamous (NSQ) NSCLC in the first-line setting.
- Substudy 2 will evaluate the safety and efficacy of DS-3939a in combination with DS-1103a or as a monotherapy in participants with locally advanced unresectable or metastatic NSQ NSCLC who are pretreated.
Each sub study will be conducted in 2 parts: Dose escalation (Part 1) and Dose expansion (Part 2). The allocation of participants in Part 1 will be non-randomized, and in Part 2, it will be randomized for both substudies.
- Conditions
- Solid Tumor, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
- Being tested
- DS-3939a, Pembrolizumab, Carboplatin, Pemetrexed, DS-1103a
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-3939aDrug
DS-3939a will be administered as an IV infusion.
PembrolizumabDrug
Also called MK-3475
Pembrolizumab will be administered as an IV infusion.
CarboplatinDrug
Carboplatin will be administered as an IV infusion.
PemetrexedDrug
Pemetrexed will be administered as an IV infusion.
DS-1103aDrug
DS-1103a will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1: Part 1: Cohort A: DS-3939a + Pembrolizumab | Experimental | Participants will receive intravenous (IV) infusion of DS-3939a, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 milligrams (mg), Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles or until treatment discontinuation criteria are me. Receives: Drug: DS-3939a; Drug: Pembrolizumab |
| Substudy 1: Part 1: Cohort B: DS-3939a + Pembrolizumab + Carboplatin | Experimental | Participants will receive IV infusion of DS-3939a, Q3W on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per RECIST v1.1 by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and carboplatin at area under the curve (AUC) 5, Q3W on Day 1 of each 21-day cycle up to maximum of 4 cycles or until the discontinuation criteria are met. Receives: Drug: DS-3939a; Drug: Pembrolizumab; Drug: Carboplatin |
| Substudy 1: Part 1: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed | Experimental | Participants will receive IV infusion of DS-3939a, Q3W on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per RECIST v1.1 by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and pemetrexed 500 milligrams per meter square (mg/m^2), Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met. Receives: Drug: DS-3939a; Drug: Pembrolizumab; Drug: Pemetrexed |
| Substudy 1: Part 2: Cohort A: DS-3939a + Pembrolizumab | Experimental | Participants will receive IV infusion of DS-3939a at the recommended dose for expansion (RDE) based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles or until the discontinuation criteria are met. Receives: Drug: DS-3939a; Drug: Pembrolizumab |
| Substudy 1: Part 2: Cohort B: DS-3939a + Pembrolizumab + Carboplatin | Experimental | Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and carboplatin at AUC 5, Q3W on Day 1 of each 21-day cycle up to a maximum of 4 cycles or until the discontinuation criteria are met. Receives: Drug: DS-3939a; Drug: Pembrolizumab; Drug: Carboplatin |
| Substudy 1: Part 2: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed | Experimental | Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and pemetrexed 500 mg/m^2, Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met. Receives: Drug: DS-3939a; Drug: Pembrolizumab; Drug: Pemetrexed |
| Substudy 1: Part 2: Cohort D: Pembrolizumab + Carboplatin + Pemetrexed | Active comparator | Participants will receive IV infusions of pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles, along with carboplatin at AUC 5, Q3W on Day 1 of each 21-day cycle up to maximum of 4 cycles and pemetrexed 500 mg/m^2, Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed |
| Substudy 2: Part 1: DS-3939a + DS-1103a | Experimental | Participants will receive IV infusion of DS-3939a, along with DS-1103a, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met. Receives: Drug: DS-3939a; Drug: DS-1103a |
| Substudy 2: Part 2: DS-3939a + DS-1103a | Experimental | Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with DS-1103a, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met. Receives: Drug: DS-3939a; Drug: DS-1103a |
| Substudy 2: Part 2: DS-3939a | Active comparator | Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met. Receives: Drug: DS-3939a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
DLT is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc., that occurs during the DLT-evaluation Period (Day 1 to the end of Cycle 1) and is Grade ≥3. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Measured: During first cycle (Cycle length=21 days)
Part 1: Number of Participants With TEAEs
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 50 days after the last dose date of trial intervention, unless otherwise specified in the applicable sub-study protocol).
Measured: Up to approximately 4 years
Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator
OR is defined as participants with a best overall response (BOR) of confirmed response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST v1.1.
Measured: Up to approximately 4 years
Secondary outcomes (20)
Part 1: OR Per RECIST v1.1 as Assessed by Investigator
OR is defined as participants with a BOR of confirmed CR or confirmed PR as assessed by investigator per RECIST v1.1.
Measured: Up to approximately 5 years
Part 2: Number of Participants With TEAEs
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 50 days after the last dose date of trial intervention, unless otherwise specified in the applicable sub-study protocol).
Measured: Up to approximately 5 years
Parts 1 and 2: Duration of Response (DoR)
DoR is defined as the time (month) from date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression or death due to any cause.
Measured: Up to approximately 5 years
Parts 1 and 2: Disease Control Rate (DCR)
Disease control is defined as participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) per RECIST v1.1. DCR is defined as the percentage of participants with disease control.
Measured: Up to approximately 5 years
Parts 1 and 2: Time To Response (TTR)
TTR is defined as the time (month) from the first dose of any trial intervention(s) to the date of the first documentation of objective response in responders (BOR of confirmed CR or confirmed PR).
Measured: Up to approximately 5 years
Parts 1 and 2: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors
The best percentage change in SoD is defined as the percentage change in the smallest SoD from all postbaseline tumor assessments, taking as reference the baseline SoD. SoD is the sum of diameters from all measurable target lesions.
Measured: Up to approximately 5 years
Parts 1 and 2: Progression-Free Survival (PFS) Per RECIST v1.1 as Assessed by Investigator
PFS is defined as the time (month) from the first dose of any trial intervention(s) to the earlier date of the first objective documentation of radiographic disease progression as assessed by investigator per RECIST v1.1 or death due to any cause.
Measured: Up to approximately 5 years
Parts 1 and 2: Overall Survival (OS)
OS is defined as the time from the first dose of any trial intervention(s) to death due to any cause.
Measured: Up to approximately 5 years
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Time to Reach Maximum Plasma Concentration (Tmax) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Area Under the Concentration-time Curve up to Time Tau (AUCtau) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Trough Concentration (Ctrough) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Percentage of Participants With Positive Anti-Drug Antibody (ADA) Against DS-3939a
Measured: Up to approximately 5 years
Substudy 2: AUClast of DS-1103a Dosed in Combination With DS-3939a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: AUCtau of DS-1103a Dosed in Combination With DS-3939a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Cmax of DS-1103a Dosed in Combination With DS-3939a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Tmax of DS-1103a Dosed in Combination With DS-3939a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Ctrough of DS-1103a Dosed in Combination With DS-3939a
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Percentage of Participants With Positive ADA for DS-1103a Dosed in Combination With DS-3939a
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start13 Oct 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion29 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739966
- Sponsor's protocol ID
- DS3939-156
- Other IDs
- 2026-525218-75-00
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Multicenter, 2-part, Open-label Trial to Evaluate DS-3939a in Participants With Solid Tumors
- ClinicalTrials.gov ID
- NCT07739966
- Acronym / sponsor ID
- DS3939-156
- Conditions
- Solid Tumor, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 29 Jan 2032 (estimated)
- First posted
- 31 Jul 2026 (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.
The primary purpose of the study is to evaluate the safety, tolerability, and efficacy of DS-3939a in combination with other anticancer agents or as a monotherapy in participants with solid tumors.
Detailed description
The study includes 2 independent substudies, which have been defined by treatment combination and participant population as follows:
- Substudy 1 will evaluate the safety and efficacy of DS-3939a in combination with immunotherapy with or without chemotherapy (carboplatin or pemetrexed) in participants with locally advanced unresectable or metastatic non-squamous (NSQ) NSCLC in the first-line setting.
- Substudy 2 will evaluate the safety and efficacy of DS-3939a in combination with DS-1103a or as a monotherapy in participants with locally advanced unresectable or metastatic NSQ NSCLC who are pretreated.
Each sub study will be conducted in 2 parts: Dose escalation (Part 1) and Dose expansion (Part 2). The allocation of participants in Part 1 will be non-randomized, and in Part 2, it will be randomized for both substudies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Substudy 1: Part 1: Cohort A: DS-3939a + Pembrolizumab | Experimental | Drug: DS-3939a, Drug: PembrolizumabParticipants will receive intravenous (IV) infusion of DS-3939a, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 milligrams (mg), Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles or until treatment discontinuation criteria are me. |
| Substudy 1: Part 1: Cohort B: DS-3939a + Pembrolizumab + Carboplatin | Experimental | Drug: DS-3939a, Drug: Pembrolizumab, Drug: CarboplatinParticipants will receive IV infusion of DS-3939a, Q3W on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per RECIST v1.1 by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and carboplatin at area under the curve (AUC) 5, Q3W on Day 1 of each 21-day cycle up to maximum of 4 cycles or until the discontinuation criteria are met. |
| Substudy 1: Part 1: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed | Experimental | Drug: DS-3939a, Drug: Pembrolizumab, Drug: PemetrexedParticipants will receive IV infusion of DS-3939a, Q3W on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per RECIST v1.1 by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and pemetrexed 500 milligrams per meter square (mg/m^2), Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met. |
| Substudy 1: Part 2: Cohort A: DS-3939a + Pembrolizumab | Experimental | Drug: DS-3939a, Drug: PembrolizumabParticipants will receive IV infusion of DS-3939a at the recommended dose for expansion (RDE) based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles or until the discontinuation criteria are met. |
| Substudy 1: Part 2: Cohort B: DS-3939a + Pembrolizumab + Carboplatin | Experimental | Drug: DS-3939a, Drug: Pembrolizumab, Drug: CarboplatinParticipants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and carboplatin at AUC 5, Q3W on Day 1 of each 21-day cycle up to a maximum of 4 cycles or until the discontinuation criteria are met. |
| Substudy 1: Part 2: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed | Experimental | Drug: DS-3939a, Drug: Pembrolizumab, Drug: PemetrexedParticipants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and pemetrexed 500 mg/m^2, Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met. |
| Substudy 1: Part 2: Cohort D: Pembrolizumab + Carboplatin + Pemetrexed | Active comparator | Drug: Pembrolizumab, Drug: Carboplatin, Drug: PemetrexedParticipants will receive IV infusions of pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles, along with carboplatin at AUC 5, Q3W on Day 1 of each 21-day cycle up to maximum of 4 cycles and pemetrexed 500 mg/m^2, Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met. |
| Substudy 2: Part 1: DS-3939a + DS-1103a | Experimental | Drug: DS-3939a, Drug: DS-1103aParticipants will receive IV infusion of DS-3939a, along with DS-1103a, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met. |
| Substudy 2: Part 2: DS-3939a + DS-1103a | Experimental | Drug: DS-3939a, Drug: DS-1103aParticipants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with DS-1103a, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met. |
| Substudy 2: Part 2: DS-3939a | Active comparator | Drug: DS-3939aParticipants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.
- Adults greater than or equal to (≥)18 years of age at the time the Main Trial ICF is signed (follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).
- Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC.
- Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days of the first trial intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions.
Key exclusion criteria (9 listed)
- Prior systemic anticancer therapy targeting MUC1 or TA-MUC1.
- Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan).
- Has spinal cord compression or clinically active central nervous system (CNS) metastases.
- Has multiple primary malignancies.
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening
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 |
|---|---|---|
| DS-3939aDS-3939a will be administered as an IV infusion. | Drug | Substudy 1: Part 1: Cohort A: DS-3939a + Pembrolizumab, Substudy 1: Part 1: Cohort B: DS-3939a + Pembrolizumab + Carboplatin, Substudy 1: Part 1: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed, Substudy 1: Part 2: Cohort A: DS-3939a + Pembrolizumab, Substudy 1: Part 2: Cohort B: DS-3939a + Pembrolizumab + Carboplatin, Substudy 1: Part 2: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed, Substudy 2: Part 1: DS-3939a + DS-1103a, Substudy 2: Part 2: DS-3939a, Substudy 2: Part 2: DS-3939a + DS-1103a |
| PembrolizumabAlso: MK-3475Pembrolizumab will be administered as an IV infusion. | Drug | Substudy 1: Part 1: Cohort A: DS-3939a + Pembrolizumab, Substudy 1: Part 1: Cohort B: DS-3939a + Pembrolizumab + Carboplatin, Substudy 1: Part 1: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed, Substudy 1: Part 2: Cohort A: DS-3939a + Pembrolizumab, Substudy 1: Part 2: Cohort B: DS-3939a + Pembrolizumab + Carboplatin, Substudy 1: Part 2: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed, Substudy 1: Part 2: Cohort D: Pembrolizumab + Carboplatin + Pemetrexed |
| CarboplatinCarboplatin will be administered as an IV infusion. | Drug | Substudy 1: Part 1: Cohort B: DS-3939a + Pembrolizumab + Carboplatin, Substudy 1: Part 2: Cohort B: DS-3939a + Pembrolizumab + Carboplatin, Substudy 1: Part 2: Cohort D: Pembrolizumab + Carboplatin + Pemetrexed |
| PemetrexedPemetrexed will be administered as an IV infusion. | Drug | Substudy 1: Part 1: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed, Substudy 1: Part 2: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed, Substudy 1: Part 2: Cohort D: Pembrolizumab + Carboplatin + Pemetrexed |
| DS-1103aDS-1103a will be administered as an IV infusion. | Drug | Substudy 2: Part 1: DS-3939a + DS-1103a, Substudy 2: Part 2: DS-3939a + DS-1103a |
Primary outcome
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: During first cycle (Cycle length=21 days)
DLT is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc., that occurs during the DLT-evaluation Period (Day 1 to the end of Cycle 1) and is Grade ≥3. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Part 1: Number of Participants With TEAEs
Time frame: Up to approximately 4 years
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 50 days after the last dose date of trial intervention, unless otherwise specified in the applicable sub-study protocol).
Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator
Time frame: Up to approximately 4 years
OR is defined as participants with a best overall response (BOR) of confirmed response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST v1.1.
20 secondary outcomes
Part 1: OR Per RECIST v1.1 as Assessed by Investigator
Time frame: Up to approximately 5 years
Part 2: Number of Participants With TEAEs
Time frame: Up to approximately 5 years
Parts 1 and 2: Duration of Response (DoR)
Time frame: Up to approximately 5 years
Parts 1 and 2: Disease Control Rate (DCR)
Time frame: Up to approximately 5 years
Parts 1 and 2: Time To Response (TTR)
Time frame: Up to approximately 5 years
Parts 1 and 2: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors
Time frame: Up to approximately 5 years
Parts 1 and 2: Progression-Free Survival (PFS) Per RECIST v1.1 as Assessed by Investigator
Time frame: Up to approximately 5 years
Parts 1 and 2: Overall Survival (OS)
Time frame: Up to approximately 5 years
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Time to Reach Maximum Plasma Concentration (Tmax) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Area Under the Concentration-time Curve up to Time Tau (AUCtau) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Trough Concentration (Ctrough) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Parts 1 and 2: Percentage of Participants With Positive Anti-Drug Antibody (ADA) Against DS-3939a
Time frame: Up to approximately 5 years
Substudy 2: AUClast of DS-1103a Dosed in Combination With DS-3939a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: AUCtau of DS-1103a Dosed in Combination With DS-3939a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Cmax of DS-1103a Dosed in Combination With DS-3939a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Tmax of DS-1103a Dosed in Combination With DS-3939a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Ctrough of DS-1103a Dosed in Combination With DS-3939a
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)
Substudy 2: Percentage of Participants With Positive ADA for DS-1103a Dosed in Combination With DS-3939a
Time frame: Up to approximately 5 years
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 28 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
76 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DS-3939a, Pembrolizumab and Carboplatin in people with Solid Tumor and Locally Advanced Non-Small Cell Lung Cancer, run by Daiichi Sankyo at 76 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 13 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in China, France, Spain, United States, Italy 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 combined 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.
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?
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?
Contact Daiichi Sankyo Contact for Clinical Trial Information (9089926400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: During first cycle (Cycle length=21 days)). The study lists 3 primary outcomes in all. 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 28 Oct 2026.