NCT07834359

Brief Summary

This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
595

participants targeted

Target at P75+ for phase_1

Timeline
39mo left

Started Oct 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

September 10, 2026

Last Update Submit

September 16, 2026

Conditions

Solid Tumors

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (2)

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

    RDE will be determined using DLTs and number of participants with treatment-related adverse events as assessed by CTCAE v6.0 and preliminary clinical efficacy

    From Day 1 to 21 days after first dose

  • Recommended dose for expansion (RDE) of HS-20197 monotherapy

    To comprehensively evaluate the safety, pharmacokinetic profile, and preliminary clinical efficacy to determine the recommended dose for expansion (RDE).

    From Day 1 to 90 days after last dose

Secondary Outcomes (10)

  • Objective response rate (ORR)

    From screening to up to 3 years after last dose

  • Disease control rate (DCR)

    From screening to up to 3 years after last dose

  • Duration of response (DoR)

    From screening to up to 3 years after last dose

  • Progression-free survival (PFS)

    From screening to up to 3 years after last dose

  • Overall survival (OS)

    From screening to up to 3 years after last dose

  • +5 more secondary outcomes

Study Arms (2)

Phase Ia：Dose escalation

EXPERIMENTAL
Drug: HS-20197

Phase 1b Dose expansion

EXPERIMENTAL
Drug: HS-20197

Interventions

HS-20197DRUG

HS-20197 (Phase Ia：Dose escalation ) * HS-20197 for IV infusion of various dose strengths administered in 21 day dosing cycles HS-20197 (Phase Ib:Dose expansion ) * The recommended dose from the dose-escalation stage and other potential doses will be further explored

Phase 1b Dose expansionPhase Ia：Dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Central Study Contacts

Ruihua Xu, PhD

CONTACT

+86-20-87343468xurh2@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 22, 2026

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations

CN(1)