A Phase 1/2, First-In-Human, Multi-Part, Open Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

Advanced Solid Tumors

The primary endpoints in Phase 1/1b are: Occurrence of DLTs during the first 3 weeks of treatment., The primary endpoints in Phase 2 are, for each cohort: Confirmed ORR, per RECIST 1.1, as adjudicated by an IERC.

1. Phase 1/1b Number, severity, and duration of treatment emergent AEs (TEAEs) for all dose groups/indications according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0., 2. Phase 1/1b Change from baseline in laboratory parameters, electrocardiograms (ECGs), vital signs, and Eastern Cooperative Oncology Group (ECOG) performance status., 3. Phase 1/1b DOR according to RECIST 1.1, per Investigator assessment., 4. Phase 1/1b PK parameters for DF6002 (including AUC0-t, AUC0-∞, , Cmax, tmax, and t½, trough concentration [Ctrough]), and nivolumab (concentration at the end of the infusion [Ceoi] and Ctrough), 5. Phase 1/1b BOR, according to RECIST 1.1, per Investigator assessment., 6. Phase 1/1b CBR according to RECIST 1.1, per Investigator assessment., 7. Phase 1/1bThe confirmed ORR, per RECIST 1.1, per investigator assessment., 8. Phase 2 Number, severity, and duration of TEAEs for all dose groups/indications according to the NCI-CTCAE v5.0., 9. Phase 2 Change from baseline in laboratory parameters, ECGs, vital signs, and ECOG performance status., 10. Phase 2 BOR according to RECIST 1.1, per Investigator assessment., 11. Phase 2 PFS according to RECIST 1.1, per Investigator assessment, 12. Phase 2 CBR according to RECIST 1.1, per Investigator assessment, 13. Phase 2 DOR according to RECIST 1.1, per Investigator assessment, 14. Phase 2 CBR according to RECIST 1.1, per IERC., 15. Phase 2 PFS according to RECIST 1.1, per IERC., 16. Phase 2 DOR according to RECIST 1.1, per IERC., 17. Phase 2 Unconfirmed response after 4 cycles according to RECIST 1.1., 18. Phase 2 PK parameters (including AUC0-t, AUC0-∞, , Cmax, Ctrough, tmax, and t½) (all cohorts) and additionally for nivolumab (Ceoi and Ctrough) (Cohort 2C and Cohort 2D).

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