Phase
Condition
Solid Tumors
Neoplasms
Treatment
HS-20110 (Phase Ia:Dose escalation )
HS-20110 (Phase Ib:Dose expansion )
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females, aged ≥ 18 years.
Participants with pathologically (histologically or cytologically) confirmedadvanced solid tumors.
Participants have at least 1 target lesion other than CNS lesions according toRECIST 1.1.
Exclusion
Exclusion Criteria:
Participants have received or are receiving the following treatment:
Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonalantibodies, bispecific antibodies, antibody-drug conjugates, or chimericantigen receptor T cells).
Anti-tumor drugs within 14 days prior to the first dose of study treatment; anyother IMPs or macromolecular anti-tumor drugs within 28 days prior to the firstdose 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 4weeks prior to the first dose of study treatment.
Major surgery within 4 weeks prior to the first dose of study treatment.
Participants previously treated with drugs that are moderate to stronginhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, stronginhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancerresistance protein (BCRP) or drugs with a narrow therapeutic range that aresensitive substrates of P-gp or BCRP within 7 days prior to the first dose ofthe IMP. Participants who need to receive these drugs during the study periodshould also be excluded.
Current use of drugs known to prolong the QT interval or that may cause torsadede pointes. Participants who need to receive these drugs during the studyperiod should also be excluded.
Live vaccine or live-attenuated vaccine within 28 weeks prior to the firstdose.
Participants who have any Grade ≥ 2 residual toxicity according to CommonTerminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).
Inadequate bone marrow reserve or hepatic and renal functions.
Participants with a history of severe allergy (such as anaphylactic shock), previoussevere infusion reactions, or allergy to recombinant human or murine proteins.
Participants who are allergic to any component of HS-20110.
Study Design
Connect with a study center
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
SUN YAT-SEN University Cancer Center
Guangzhou 1809858, Guangdong 1809935 510000
ChinaSite Not Available
BRCR Medical Center INC
Tamarac, Florida 33321
United StatesActive - Recruiting
BRCR Medical Center INC
Tamarac 4174738, Florida 4155751 33321
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Dallas
Irving, Texas 75039
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
NEXT Dallas
Irving 4700168, Texas 4736286 75039
United StatesSite Not Available
NEXT Oncology
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
NEXT Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
NEXT Virginia
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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