A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,641

Keywords

• Dato-DXd
• TROPION
• DS-1062a
• Datopotamab Deruxtecan
• Trophoblast cell surface protein 2 (TROP2)

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 268 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Daiichi Sankyo is the lead sponsor of 322 studies on the registry; 37 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Sub-study 1: Phase 1: Part 1: Dato-DXd + EV

  Participants will be administered Dato-DXd, intravenously (IV), along with EV, administered IV.

  Drug: Dato-DXd · Drug: Enfortumab Vedotin (EV)

• Experimental
  Sub-study 1: Phase 1: Part 2: Dato-DXd + EV + Pembrolizumab

  Based on the maximum tolerated dose (MTD) determined by Phase 1 Part 1, participants will be administered Dato-DXd, IV, along with EV and pembrolizumab, administered IV.

  Drug: Dato-DXd · Drug: Enfortumab Vedotin (EV) · Drug: Pembrolizumab

• Experimental
  Sub-study 1: Phase 2: Group A: Dato-DXd + EV + Pembrolizumab

  Participants will be administered Dato-DXd, at recommended Phase 2 dose (RP2D) based on Phase 1 data, along with EV and pembrolizumab, administered IV.

  Drug: Dato-DXd · Drug: Enfortumab Vedotin (EV) · Drug: Pembrolizumab

• Active comparator
  Sub-study 1: Phase 2: Group B: EV + Pembrolizumab

  Participants will be administered EV, IV, along with pembrolizumab, IV.

  Drug: Enfortumab Vedotin (EV) · Drug: Pembrolizumab

• Experimental
  Sub-study 2: Phase 1: Cohort A: Dato-DXd + Olomorasib

  Participants will be administered Dato-DXd, IV, along with olomorasib, administered orally.

  Drug: Dato-DXd · Drug: Olomorasib

• Experimental
  Sub-study 2: Phase 2: Dato-DXd + Olomorasib

  Participants will be administered Dato-DXd along with Olomorasib at RP2D, based on Part 1 data.

  Drug: Dato-DXd · Drug: Olomorasib

Interventions

• DrugDato-DXd

  Dato-DXd will be administered as an IV infusion.

  Also known as: DS-1062a

• DrugEnfortumab Vedotin (EV)

  EV will be administered as IV infusion.

• DrugPembrolizumab

  Pembrolizumab will be administered as an IV infusion.

• DrugOlomorasib

  Olomorasib will be administered as oral capsules.

Primary outcomes

1. Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

   DLTs are defined as the events pre-specified in the protocol and which are not clearly due to the underlying disease or extraneous causes. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

   Time frame: During Cycle 1 (cycle length = 21 days)

2. Phase 1: Number of Participants With Treatment-emergent Adverse Events (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), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the start date of trial intervention to 35 days \[28 (+7) days\] after the last dose date of trial intervention).

   Time frame: Up to approximately 2.9 years

3. Phase 2: Objective Response Rate (ORR) as Assessed by Investigator

   Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by the investigator per RECIST v1.1.

   Time frame: Up to approximately 2.9 years

Secondary outcomes

1. Phase 1: ORR as Assessed by Investigator

   ORR is defined as the percentage of participants with a BOR of confirmed CR or confirmed PR, as assessed by the investigator per RECIST v1.1.

   Time frame: Up to approximately 2.9 years

2. Phase 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), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as those AEs with start or worsening date during the on-treatment period (from the start date of trial intervention to 35 days \[28 (+7) days\] after the last dose date of trial intervention).

   Time frame: Up to approximately 2.9 years

3. Phase 1 and 2: Duration of Response (DoR) as Assessed by the Investigator

   DoR is defined as the time (in months) from the 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.

   Time frame: Up to approximately 2.9 years

4. Phase 1 and 2: Clinical Benefit Rate (CBR) as Assessed by the Investigator

   CBR is defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) lasting ≥183 days, as assessed by the investigator per RECIST v1.1.

   Time frame: Up to approximately 2.9 years

5. Phase 1 and 2: Disease Control Rate (DCR) as Assessed by the Investigator

   DCR is defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD as assessed by the investigator per RECIST v1.1.

   Time frame: Up to approximately 2.9 years

6. Phase 1 and 2: Time to Response (TTR) as Assessed by the Investigator

   TTR is defined as the time (in months) from the start date of trial intervention (randomization for randomized cohort) to the date of the first documentation of objective response in responders (BOR of confirmed CR or confirmed PR as assessed by the investigator per RECIST v1.1).

   Time frame: Up to approximately 2.9 years

7. Phase 1 and 2: Best Percentage Change in the SoD of Measurable Tumors as Assessed by Investigator

   The best percentage change in SoD as assessed by the investigator per RECIST v1.1, defined as the percentage change in the smallest SoD from all postbaseline tumor assessments, taking as reference the baseline SoD.

   Time frame: Up to approximately 2.9 years

8. Phase 1 and 2: Progression-free Survival (PFS) as Assessed by the Investigator

   PFS is defined as the time (in months) from the start date of trial intervention (randomization for randomized cohort) 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.

   Time frame: Up to approximately 2.9 years

9. Phase 1 and 2: Overall Survival (OS)

   OS is defined as the time (in months) from the start date of trial intervention (date of randomization for randomized cohort) to the date of death due to any cause.

   Time frame: Up to approximately 2.9 years

10. Phase 1 and 2: Plasma Concentration of Dato-DXd, Total Anti-TROP2 Antibody and MAAA-1181a

    Time frame: Pre-dose and at multiple timepoints post-dose from Cycle 1 up to Cycle 8 (each cycle=21 days)

11. Phase 1 and 2: Percentage of Participants With Positive Anti-drug Antibodies (ADAs)

    Time frame: Up to approximately 2.9 years

Individual participant data

Plan to share: 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/

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Data sharing details ↗ · vivli.org