Phase I/II Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors

NCT07769242 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-8203-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (5)

• The number of subjects with dose-limiting toxicity (DLT)

  From first dose of study treatment until the end of Cycle 1（up to 21 days）

• Incidence and severity of AEs

  From the first visit to the end of the safety follow-up period (1 year)

• Maximum Tolerated Dose

  During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)（up to 21 days）

• Determination of Recommended Phase II dose (RP2D)

  After dose optimization, sufficient safety, tolerability, PK and preliminary efficacy results were obtained, and the dose selected for the subsequent indication expansion stage was confirmed by SRC discussion (1 year).

• Objective Response Rate (ORR)

  From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)

Secondary Outcomes (4)

• Duration of Response (DoR)

  From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)

• Disease Control Rate (DCR)

  From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)

• Progression free Survival (PFS)

  From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)

• Overall Survival (OS)

  From time of first dose of objective disease progression until the date of death (2 years)

Study Arms (1)

SHR-8203 Injection

EXPERIMENTAL

Drug: SHR-8203 Injection

Interventions

SHR-8203 Injection DRUG

SHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4

SHR-8203 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years old, gender not limited;
• Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.
• Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;
• Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.
• Have at least one measurable lesion as per RECIST v1.1;
• ECOG PS score: 0-1;
• Good organ function level.

You may not qualify if:

• Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;
• Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;
• Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;
• Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;
• Participants who have experienced severe infections within one month prior to the first medication.

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Central Study Contacts

Fang fang Peng, Doctoral degree

CONTACT

17721288185; fangfang.peng.fp5@hengrui.com

Xin Xu, Bachelor's degree

CONTACT

18036618833; xin.xu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

CN (1)