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

NCT07660432
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
472
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Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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Start date
2026-07-03
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Number of sites
6
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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.
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Short title
A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-06-01
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First posted
2026-06-22
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Registry last updated
2026-08-20
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Primary completion date
2028-12-01
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Start date
2026-07-03
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Participants
472
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Participant count basis
Estimated
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Planned participants
472
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Protocol amendments
0
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Number of sites
6
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Registry sponsor category
Industry
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Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07660432
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ClinicalTrials.gov ID
NCT07660432
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Dose-limiting toxicity (DLT) (Dose escalation)

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

    DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria.

  2. Maximum tolerated dose (MTD)and / or Recommended dose (RD) (Dose escalation)

    Timeframe: Up to approximately 2 years

    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

  3. Objective Response Rate (ORR) (Dose expansion)

    Timeframe: Up to approximately 2 years

    ORR is the proportion of participants with complete response(CR)or partial response (PR) assessed according to RECIST v1.1.

  1. Adverse event rate

    Timeframe: up to approximately 2 years

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

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

    Timeframe: up to approximately 2 years

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

  3. Pharmacokinetics: Peak concentration (Cmax)

    Timeframe: Up to approximately 2 years

    Maximum observed concentration (Cmax) of SIM0689

  4. Pharmacokinetics: T1/2

    Timeframe: Up to approximately 2 years

    Terminal half-life (T1/2)

  5. Pharmacokinetics: Tmax

    Timeframe: Up to approximately 2 years

    Time to maximum concentration

  6. Immunogenicity

    Timeframe: Up to approximately 2 years

    Titer of serum anti-SIM0689 antibodies

  7. Immunogenicity

    Timeframe: Up to approximately 2 years

    Incidence rate of serum anti-SIM0689 antibodies

  8. Immunogenicity

    Timeframe: Up to approximately 2 years

    Duration of serum anti-SIM0689 antibodies

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Fujian Cancer HospitalFuzhou, ChinaRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNot yet recruiting
  • Hunan Cancer HospitalChangsha, ChinaNot yet recruiting
  • The First Hospital of China Medical UniversityShenyang, ChinaNot yet recruiting
  • Cancer Hospital of Shandong First Medical UniversityJinan, ChinaNot yet recruiting
  • The First Affiliated Hospital, Zhejiang University school of MedicineHangzhou, ChinaRecruiting
Sources for sites
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Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)