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New treatment option for Advanced Solid Tumours
Official title First in Human Study of SIM0610 in Solid Tumors
ClinicalTrials.gov ID: NCT07348211
What this study is testing
What is SIM0610 for Injection?
SIM0610 for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntarily participate and sign the informed consent form
- At least 18 years old, male or female
- people with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;
- people in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and people in Part 2 should have at least one measurable...
- people with locally advanced/metastatic solid tumors who have failed standard treatment: Part 1: people with solid tumors who have experienced...
You likely can't join if
- A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of...
- Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local...
- A history of non-infectious interstitial lung disease (ILD)/pulmonary inflammation requiring corticosteroid treatment; current ILD/pulmonary...
- Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4...
- Failure to recover from adverse events (AEs) induced by prior anti-tumor therapy (i.e., recovery to Grade 1 or baseline level).
- Current participation in a study involving investigational drugs or medical devices, or participation in such a study within 4 weeks prior to the...
See the full eligibility criteria
Who can join
- Voluntarily participate and sign the informed consent form
- At least 18 years old, male or female
- people with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;
- people in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and people in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or...
- people with locally advanced/metastatic solid tumors who have failed standard treatment: Part 1: people with solid tumors who have experienced disease progression during/after at least one previous standard systemic...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival period ≥ 12 weeks
- Adequate organ and bone marrow function
- Archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue or fresh biopsy tissue within 5 years must be provided before the first administration
What rules you out
- A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of recurrence as assessed by the investigator.
- Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local therapy (e.g., radiotherapy or surgery) for CNS metastases; or...
- A history of non-infectious interstitial lung disease (ILD)/pulmonary inflammation requiring corticosteroid treatment; current ILD/pulmonary inflammation; or suspected ILD/pulmonary inflammation that cannot be ruled out...
- Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.
- Failure to recover from adverse events (AEs) induced by prior anti-tumor therapy (i.e., recovery to Grade 1 or baseline level).
- Current participation in a study involving investigational drugs or medical devices, or participation in such a study within 4 weeks prior to the first dose of study treatment.
- Receipt of the following therapies prior to the first dose of study treatment:
- Cytotoxic therapy within 3 weeks; or anti-tumor targeted small-molecule drugs (e.g., tyrosine kinase inhibitors) within 2 weeks.
- Anti-tumor antibody-based immune checkpoint inhibitors, antibody-drug conjugates (ADCs), or other anti-tumor biologics within the shorter of 5 half-lives or 4 weeks.
- Traditional Chinese medicines (TCMs)/herbal preparations with anti-tumor indications within 2 weeks.
- Radiotherapy within 4 weeks.
- Received antibody-drug conjugate (ADC) with topoisomerase I inhibitor (TOP1i) or other ADC targeting EGFR/cMET.
- Received any live vaccine within 4 weeks prior to the first dose of study treatment.
- Received the following medications ≤ 14 days prior to the first dose of study treatment:
- Strong or moderate CYP3A4 induction/inhibitor;
- Drugs known to be at risk for torsade de pointes (TdP);
- Drugs associated with QTcF interval prolongation (TdP risk equivocal).
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
- A history of clinically significant cardiovascular diseases within 6 months prior to the first dose of study treatment, including but not limited to myocardial infarction, severe/unstable angina pectoris, primary...
- A history of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- A history of hypersensitivity to the active ingredients, inactive excipients of SIM0610, or drugs with similar chemical structures or classifications to SIM0610.
- Pregnant or lactating women. For women of childbearing potential (WOCBP), they are also excluded unless:
- The result of serum pregnancy test within 72 hours prior to the first dose of study treatment is negative;
- They use highly effective contraceptive methods from the time of signing the informed consent form (ICF) until 180 days after the last dose of study treatment.
- Male people with female partners of childbearing potential are excluded unless they use highly effective contraceptive methods from the time of signing the ICF until 180 days after the last dose of study treatment.
- Any other conditions that may increase subject-related risks or interfere with the interpretation of study results, and that, in the investigator's judgment, render the subject unsuitable for study enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Harbin, Heilongjiang, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Harbin, Heilongjiang, China; Shenyang, Liaoning, China; Jinan, Shandong, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.