A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors

NCT07298772 | Recruiting Phase 1

• 1 other identifier: SHR-4375-201
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT).

  3 weeks.

• Recommended phase II dose (RP2D).

  From screening period up to study completion, an average of 1 year.

• Adverse events (AEs).

  From screening period up to study completion, an average of 1 year.

• Objective response rate (ORR).

  From screening period up to study completion, an average of 1 year.

Secondary Outcomes (4)

• Disease control rate (DCR)

  From screening period up to study completion, an average of 1 year.

• Duration of response (DoR)

  From screening period up to study completion, an average of 1 year.

• Progression-free survival (PFS)

  From screening period up to study completion, an average of 1 year.

• Drug Resistant Antibody (ADA) to SHR-4375

  From screening period up to study completion, an average of 1 year.

Study Arms (1)

SHR-4375 Injection in Combination With Other Antitumor Therapies Group

EXPERIMENTAL

Drug: SHR-4375 Injection

Interventions

SHR-4375 Injection DRUG

SHR-4375 injection in combination with other antitumor therapies.

SHR-4375 Injection in Combination With Other Antitumor Therapies Group

Eligibility Criteria

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

You may qualify if:

• Voluntary participation and written informed consent.
• years older, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy ≥ 12 weeks.
• Patients with advanced solid tumors confirmed by cytology or histology who have failed or are intolerant to standard treatment and have no standard treatment.
• Be able to provide fresh or archived tumour tissue.
• At least one measurable lesion according to RECIST v1.1.
• Adequate bone marrow and organ function.
• Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

You may not qualify if:

• There are components of neuroendocrine carcinoma or sarcoma in the histopathological type.
• Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
• Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
• Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration.
• Previously received antibody-drug conjugate therapy containing topoisomerase I inhibitors.
• Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study.
• Suffering from other active malignant tumors within 3 years or at the same time.
• Symptomatic or active central nervous system tumor metastasis.
• Accompanied by uncontrolled tumor related pain.
• Subjects who have experienced severe infections within 30 days prior to their first medication use.
• History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past.
• AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1.
• Active hepatitis B or active hepatitis C.
• Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication.
• Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Yunpeng Jing

CONTACT

+86-0518-82342973; yunpeng.jin.yj1@hengrui.com

Hao Shen

CONTACT

+86-021-61053363; hao.shen@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: December 9, 2025
• First Posted: December 23, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CN (1)