A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Phase I First-in-Human, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms, Malignant
• Intervention / Treatment: Drug: SIM0689 for Injection

• Study Type: Interventional
• Enrollment (Estimated): 472
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tingbo Liang; Phone Number: +86 13666676121; Email: liangtingbo_trial@163.com
• Study Contact Backup: Name: Xueli Bai; Email: baixueli_trial@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Zengqing Guo
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Shuiling Jin
  • Hunan
    • Changsha, Hunan, China, 410013
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Contact: Haiyan Yang
      • Contact: Xingxiang Pu
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Not yet recruiting
      • The First Hospital of China Medical University
      • Contact: Yunpeng Liu
  • Shandong
    • Jinan, Shandong, China, 250117
      • Not yet recruiting
      • Cancer Hospital of Shandong First Medical University
      • Contact: Shuqin Ni
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Tingbo Liang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• In dose-escalation cohorts (Part 1), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
• In the dose-expansion cohorts (Part 2), histologically or cytologically confirmed selected advanced solid tumors.
• Subjects must have at least one measurable lesion according to RECIST Version1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• Adequate organ function.
• Available archived tumor tissue sample to allow for correlative biomarker studies. If unavailable or unsuitable, the subject must consent and undergo fresh tumor biopsy.
• Life expectancy ≥12 weeks.
• Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 180 days after the last dose.

Exclusion Criteria:

• Symptomatic brain metastases.
• Serious non-healing wounds, ulcers or fractures.
• Toxicity from previous treatment has to restore to ≤ grade 1.
• Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment.
• Use of aspirin (> 325 mg/day) within 6 months prior to the first dose.
• Active hepatitis B or hepatitis C.
• Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
• Known hereditary or acquired predisposition to bleeding and thrombosis.
• History of gastrointestinal perforation, gastrointestinal bleeding, fistula, or any life-threatening bleeding event within 6 months prior to enrollment.
• Prior permanent discontinuation of PD-(L)1 and/or VEGF monoclonal antibody because of immune/anti-angiogenesis toxicities, or history of Grade ≥3 immune/anti-angiogenesis-related AEs
• Known or suspected active autoimmune disease.
• Patients with proteinuria at screening (Urine protein >2+ at screening, or 2+ urine protein accompanied by 24-h urine protein ≥1 g/24 h).
• History of myocardial infarction or stroke within 6 months prior to enrollment.
• Subjects with clinically significant cardiovascular disease within 6 months prior to the first dose.
• Pregnant and lactating women.
• Known allergies to any excipient in the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIM0689 for Injection; One intravenous infusion of SIM0689 for Injection, 28 days or 21 days as a treatment cycle.	Drug: SIM0689 for Injection; SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT) (Dose escalation)	DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria.	at the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose (MTD)and / or Recommended dose (RD) (Dose escalation)	The MTD is defined as the dose of SIM0689 with an estimated toxicity rate closest to the target toxicity rate of 27%； RD stands for Recommended Dose, which will be selected based on the evaluation of all available pharmacokinetics, pharmacodynamic, efficacy, safety, and tolerability data	Up to approximately 2 years
Objective Response Rate (ORR) (Dose expansion)	ORR is the proportion of participants with complete response(CR)or partial response (PR) assessed according to RECIST v1.1.	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 6.0.	up to approximately 2 years
Pharmacokinetics: The area under the curve (AUC)	The area under the curve (AUC) of serum concentration of SIM0689	up to approximately 2 years
Pharmacokinetics: Peak concentration (Cmax)	Maximum observed concentration (Cmax) of SIM0689	Up to approximately 2 years
Pharmacokinetics: T1/2	Terminal half-life (T1/2)	Up to approximately 2 years
Pharmacokinetics: Tmax	Time to maximum concentration	Up to approximately 2 years
Immunogenicity	Titer of serum anti-SIM0689 antibodies	Up to approximately 2 years
Immunogenicity	Incidence rate of serum anti-SIM0689 antibodies	Up to approximately 2 years
Immunogenicity	Duration of serum anti-SIM0689 antibodies	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborators: Shanghai Xianwei Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: SIM0689-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No