A Study of HS-20197 in Participants With Advanced Solid Tumors

This is a multicenter, open-label, Phase I study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of intravenously administered HS-20197 in participants with advanced solid tumors. The study comprises a Phase Ia dose-escalation phase followed by a Phase Ib dose-expansion phase.

Inclusion criteria

• 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.

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Exclusion criteria

• Participants have received or are receiving the following treatment:

• 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.
• 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.
• 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.
• Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.
• Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior therapies (except alopecia and residual neurotoxicity).
• Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
• Participants who are allergic to any component of HS-20197.