This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic solid tumors. The study consists of an Escalation Phase (Phase 1a) and a Dose Expansion/Optimization Phase (Phase 1b).
Male or female patients ≥ 18 years of age.
Be willing and able to provide written informed consent for the study.
Patients in Phase 1a must have a histologically or cytologically documented, advanced (metastatic and/or unresectable) solid tumor that has progressed on or after standard therapy (relapsed/refractory patients; patients must have failed at least one prior line of therapy) or for whom there is no effective standard therapy based on the Investigator's judgment.
Non-squamous NSCLC for which prior standard first-line treatment containing an anti-PD-(1/L1) checkpoint inhibitor alone or in combination has failed and that has progressed to no more than 2 prior systemic therapies. Patients must not have presented with disease progression during the first 3 months of treatment with first line anti-PD-(1/L1)-containing therapy. Patients must have had documented disease progression per RECIST 1.1 within 12 weeks from the last dose of anti-PD-1/L1 mAb to be considered to have failed an anti-PD-(1/L1) mAb containing therapy. The initial evidence of disease progression to anti-PD-1/L1 mAb containing therapy needs to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression.
None
Sequential
DCSZ11
DrugA monoclonal antibody that binds to CD93, DCSZ11 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.
Pembrolizumab
DrugPembrolizumab injection
Doxorubicin
Drug1b SOC Cohort 1: Doxorubicin combination in soft tissue sarcoma
Tebentafusp
Drug1b SOC Cohort 2: Tebentafusp combination in uveal melanoma
Phase 1a: Incidence of dose limiting toxicites (DLTs)
Phase 1a: Frequency and severity of treatment emergent adverse events
Phase 1b: Overall response rate (ORR) per Investigator-assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
Phase 1a: Overall response rate (ORR) per Investigator-assessed RECIST v1.1
Phase 1a and b: Overall response rate (ORR) per Investigator-assessed consensus guideline developed by the RECIST Working Group for the use of modified RECIST, Version 1.1 in cancer immunotherapy trials (iRECIST)
Phase 1a and b: Duration of response (DOR) as determined per Investigator assessment by RECIST v1.1 and iRECIST
Phase 1 a and b: Disease control rate (DCR) as determined per Investigator assessment by RECIST v1.1 and iRECIST.
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