Health TrialsbyHealthPanel

A Study of HS-20110 in Participants With Advanced Solid Tumors

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females, aged ≥ 18 years.

Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.

Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.

Disqualifiers

Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor T cells).

Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.

Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.

Major surgery within 4 weeks prior to the first dose of study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • HS-20110 (Phase Ia：Dose escalation )

    Drug

    HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles

  • HS-20110 (Phase Ib:Dose expansion )

    Drug

    The recommended dose from the dose-escalation stage and other potential doses will be further explored

Treatment groups

475 Participants
are divided into 2 treatment groups
Group A: HS-20110 (Phase Ia：Dose escalation )Experimental treatment 1 intervention
Group B: HS-20110 (Phase 1b Dose expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) or maximum applicable dose (MAD)

Time frame
From day 1 to one months after the last dose in Phase 1a
2

Objective response rate (ORR) as per RECIST v1.1

Time frame
From screening to 2 months after the last dose

Secondary outcomes

1

Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities

Time frame
From the first dose until 90 days after the last dose
2

Objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; overall survival (OS)

Time frame
From screening to up to 3 years after last dose
3

Incidence of anti-HS-20110 antibody (ADA)

Time frame
From the first dose until 90 days after the last dose
4

Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload)

Time frame
From the first dose until 90 days after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Hoffmann-La Roche

Collaborator

Source ClinicalTrials.gov
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