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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2027-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HS-20110 (Phase Ia：Dose escalation )

Group Type EXPERIMENTAL

HS-20110 (Phase Ia：Dose escalation )

Intervention Type DRUG

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

HS-20110 (Phase 1b Dose expansion)

Group Type EXPERIMENTAL

HS-20110 (Phase Ib:Dose expansion )

Intervention Type DRUG

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

Interventions

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HS-20110 (Phase Ia：Dose escalation )

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

Intervention Type DRUG

HS-20110 (Phase Ib:Dose expansion )

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males or females, aged ≥ 18 years.
2. Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
3. Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.

Exclusion Criteria

1. Participants have received or are receiving the following treatment:

1. Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor T cells).
2. 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.
3. 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.
4. Major surgery within 4 weeks prior to the first dose of study treatment.
5. Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.
6. Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.
7. Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.
2. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).
3. Inadequate bone marrow reserve or hepatic and renal functions.
4. Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
5. Participants who are allergic to any component of HS-20110.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No