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Neoplasms, MalignantPhase 1NCT07660432

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

A Phase 1 study testing SIM0689 for Injection in people with Neoplasms, Malignant, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Malignant
What is being tested?
SIM0689 for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
472 participants
Where
6 sitesChina
Study dates
3 Jul 2026to Jun 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tingbo Liang contact

+86 13666676121

liangtingbo_trial@163.com

Xueli Bai contact

baixueli_trial@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Xingxiang Pu

    Haiyan Yang

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Zengqing Guo

    Recruiting

  • The First Affiliated Hospital, Zhejiang University school of Medicine

    Hangzhou, Zhejiang, 310003

    Tingbo Liang

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Shuqin Ni

    Not yet recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Yunpeng Liu

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Shuiling Jin

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Being tested
SIM0689 for Injection
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIM0689 for InjectionDrug

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

Study groups in NCT07660432
Study groupRoleWhat they receive
SIM0689 for InjectionExperimentalOne intravenous infusion of SIM0689 for Injection, 28 days or 21 days as a treatment cycle.
Receives: Drug: SIM0689 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at the end of Cycle 1 (each cycle is 28 days)

  2. 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

    Measured: Up to approximately 2 years

  3. 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.

    Measured: Up to approximately 2 years

Secondary outcomes (8)

  1. Adverse event rate

    The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 6.0.

    Measured: up to approximately 2 years

  2. Pharmacokinetics: The area under the curve (AUC)

    The area under the curve (AUC) of serum concentration of SIM0689

    Measured: up to approximately 2 years

  3. Pharmacokinetics: Peak concentration (Cmax)

    Maximum observed concentration (Cmax) of SIM0689

    Measured: Up to approximately 2 years

  4. Pharmacokinetics: T1/2

    Terminal half-life (T1/2)

    Measured: Up to approximately 2 years

  5. Pharmacokinetics: Tmax

    Time to maximum concentration

    Measured: Up to approximately 2 years

  6. Immunogenicity

    Titer of serum anti-SIM0689 antibodies

    Measured: Up to approximately 2 years

  7. Immunogenicity

    Incidence rate of serum anti-SIM0689 antibodies

    Measured: Up to approximately 2 years

  8. Immunogenicity

    Duration of serum anti-SIM0689 antibodies

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start3 Jul 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
472 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07660432
Sponsor's protocol ID
SIM0689-101
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
20 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIM0689 for Injection in people with Neoplasms, Malignant, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tingbo Liang (+86 13666676121, liangtingbo_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (Dose escalation) (time frame: at the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07660432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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