A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2029-06-30

Brief Summary

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This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors

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Detailed Description

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Conditions

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Advanced Solid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A dose escalation of SIM0609

Multiple dose levels of SIM0609 will be explored in dose escalation, and determine the maximum tolerated dose.

Group Type EXPERIMENTAL

SIM0609 for injection

Intervention Type DRUG

Multiple dose levels of SIM0609 will be explored in dose escalation

A dose expansion of SIM0609 -CRC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)

Group Type EXPERIMENTAL

dose expansion of SIM0609 in CRC

Intervention Type DRUG

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)

A dose expansion of SIM0609-GC/GEJC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC)

Group Type EXPERIMENTAL

dose expansion of SIM0609 in GC/GEJC cohort

Intervention Type DRUG

1\~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort

A dose expansion of SIM0609-PDAC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in pancreatic ductal adenocarcinoma (PDAC)

Group Type EXPERIMENTAL

dose expansion of SIM0609 in PDAC cohort

Intervention Type DRUG

1\~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort

A dose expansion of SIM0609-positive other solid tumors cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in positive other solid tumors

Group Type EXPERIMENTAL

dose expansion of SIM0609 in positive other solid tumors

Intervention Type DRUG

1\~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort

Interventions

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SIM0609 for injection

Multiple dose levels of SIM0609 will be explored in dose escalation

Intervention Type DRUG

dose expansion of SIM0609 in CRC

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)

Intervention Type DRUG

dose expansion of SIM0609 in GC/GEJC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort

Intervention Type DRUG

dose expansion of SIM0609 in PDAC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort

Intervention Type DRUG

dose expansion of SIM0609 in positive other solid tumors

1\~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Voluntary participation and signature of informed consent form;
2. At least 18 years old, male or female;
3. Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
4. Participants should have at least one evaluable or measurable tumor lesion;
5. Participants have failed the standard of therapy in the locally advanced/metastatic setting;
6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;
7. Expected survival ≥12 weeks;
8. Adequate organ and bone marrow function;
9. Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory

Exclusion Criteria

1. Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;
2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;
3. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening;
4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;
5. Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;
6. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment;
7. Not recovered from previous anticancer therapy-induced AEs(Adverse Events);
8. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment;
9. Received prior therapies within the following time frames prior to the first dose of study treatment:

1. Previous cytotoxic therapy, anticancer targeted small molecules within 2 weeks.
2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).
3. Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.
4. Radiation therapy within 4 weeks.
10. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies.
11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.
12. Administration of below medications ≤14 days prior to the first dose of study treatment.

1. Strong or moderate CYP3A4 inducers/inhibitors;
2. Drugs with known risk of Torsades de Pointes(TdP);
3. Drugs that may prolong the QT interval;
13. Major surgery within 2 weeks of receiving the first dose of study treatment;
14. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome ;
15. Active or chronic hepatitis B or hepatitis C infection;
16. Participants with clinically significant cardiovascular diseases;
17. History of allogeneic organ transplantation or graft-versus-host disease;
18. History of hypersensitivity to active or inactive excipients of SIM0609 or drugs with a similar chemical structure or class to SIM0609;
19. Pregnant or nursing (lactating) women;
20. Male participants with female partners of reproductive potential, unless they are using highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of study treatment;
21. Presence of any other condition that may increase the risk associate with study participant or may interfere with the interpretation of study results, and, in the opinion of the Investigator, would make the participant inappropriate for entry into the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, , China

Site Status RECRUITING