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

NCT07660432 | Not Yet Recruiting Phase 1

• 1 other identifier: SIM0689-101
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Neoplasms, Malignant

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Adverse event rate

  up to approximately 2 years

• Pharmacokinetics: The area under the curve (AUC)

  up to approximately 2 years

• Pharmacokinetics: Peak concentration (Cmax)

  Up to approximately 2 years

• Pharmacokinetics: T1/2

  Up to approximately 2 years

• Pharmacokinetics: Tmax

  Up to approximately 2 years

Study Arms (1)

SIM0689 for Injection

EXPERIMENTAL

One intravenous infusion of SIM0689 for Injection, 28 days or 21 days as a treatment cycle.

Drug: SIM0689 for Injection

Interventions

SIM0689 for Injection DRUG

SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.

SIM0689 for Injection

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• Shanghai Xianwei Medical Technology Co., Ltd.: collaborator

Study Sites (6)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location

The First Affiliated Hospital, Zhejiang University school of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Tingbo Liang

CONTACT

+86 13666676121; liangtingbo_trial@163.com

Xueli Bai

CONTACT

baixueli_trial@163.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: June 10, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

CN (6)