HS-20110 (Phase Ia:Dose escalation ): HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles
HS-20110 (Phase Ib:Dose expansion ): The recommended dose from the dose-escalation stage and other potential doses will be further explored
Study summary
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Maximum tolerated dose (MTD) or maximum applicable dose (MAD) — From day 1 to one months after the last dose in Phase 1a
Objective response rate (ORR) as per RECIST v1.1 — From screening to 2 months after the last dose
Trial sites (8)
Facility
City
Region
Status
BRCR Medical Center INC
Tamarac
Florida
Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne
Indiana
Recruiting
Carolina BioOncology Institute
Huntersville
North Carolina
Recruiting
The University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
NEXT Dallas
Irving
Texas
Recruiting
NEXT Oncology
San Antonio
Texas
Recruiting
NEXT Virginia
Fairfax
Virginia
Recruiting
SUN YAT-SEN University Cancer Center
Guangzhou
Guangdong
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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