A Study of IBI3043 Treatment in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors
A Phase 1, Multicenter, Open-label Study of IBI3043 Treatment in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors
A Phase 1, Multicenter, Open-label Study of IBI3043 Treatment in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors
Sponsor study identifier
interventional
604
1 country
1
Study Start
November 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3043 in participants with unresectable,locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2026
Actual (reported)October 29, 2026
Actual (reported)November 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Adverse Event (part 1)
up to 2 years
ORR (part 2)
up to 2 years
Serious Adverse Event
up to 2 years
Maximum Tolerated Dose (part 1)
up to 2 years
DLT(Dose-limiting Toxicity) (part 1)
up to 2 years
PK concentration:IBI3043 serum concentration
up to 2 years
ADA (Anti-drug antibody)
up to 2 years
Nab (Neutralizing antibody)
up to 2 years
ORR (Objective Response Rate) (part 1)
up to 2 years
DoR (Duration of Response)
up to 2 years
IBI3043 is an investigational drug administered as Q2W or Q3W according to the study protocol.
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, 510060, China
First Submitted
October 22, 2026
First Posted
October 29, 2026
Study Start
November 16, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2027
EstimatedA Study of HS-20197 in Participants With Advanced Solid Tumors
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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